Original Article
Comparison of the Effects of Oat Bran and Low-Fiber Wheat on Serum Lipoprotein Levels and Blood Pressure
N Engl J Med 1990; 322:147-152January 18, 1990
- Abstract
- Abstract
Previous studies have shown that supplementation of the diet with oat bran may lower serum cholesterol levels. However, it is not known whether oat-bran diets lower serum cholesterol levels by replacing fatty foods in the diet or by a direct effect of the dietary fiber contained in oat bran. To determine which is the case, we compared the effect of isocaloric supplements of high-fiber oat bran (87 g per day) and a low-fiber refined-wheat product on the serum lipoprotein cholesterol levels of 20 healthy subjects, 23 to 49 years old. After a one-week base-line period during which they consumed their usual diets, the subjects were given each type of supplement for six-week periods in a double-blind, crossover trial.
Mean serum cholesterol levels (±SD) were not significantly different during the high-fiber and low-fiber periods: total cholesterol, 4.44±0.73 and 4.46±0.64 mmol per liter (172±28 and 172±25 mg per deciliter); low-density lipoprotein, 2.69±0.63 and 2.77±0.59 mmol per liter (104±24 and 107±23 mg per deciliter); and high-density lipoprotein, 1.40±0.39 and 1.32±0.39 mmol per liter (54.2±15.0 and 50.9±15.2 mg per deciliter), respectively. However, both types of supplements lowered the mean base-line serum cholesterol level, 4.80±0.80 mmol per liter (186±31 mg per deciliter), by 7 to 8 percent (95 percent confidence interval for high fiber, 11 to 4 percent, and for low fiber, 11 to 3 percent). The subjects ate less saturated fat and cholesterol and more polyunsaturated fat during both periods of supplementation than at base line. Those changes in dietary fats were sufficient to explain all of the reduction in serum cholesterol levels caused by the high-fiber and low-fiber diets. The average blood pressure was 112/68 mm Hg at base line and did not change during either dietary period.
We conclude that oat bran has little cholesterol-lowering effect and that high-fiber and low-fiber dietary grain supplements reduce serum cholesterol levels about equally, probably because they replace dietary fats. (N Engl J Med 1990; 322:147–52.)
Media in This Article
Table 1
Composition of Dietary Supplements.Table 2
Intake of Nutrients and Body Weight during the High-Fiber and Low-Fiber Study Periods.*Article Activity
- Article
IT has been hypothesized that a high dietary intake of fiber among people in nonindustrialized countries may confer some protection against cardiovascular disease by lowering serum cholesterol levels and blood pressure.1 However, direct trials of supplementing the Western diet with various fibers have yielded conflicting results. Wright et al.2 reported that wheat fiber lowered blood pressure in a predominantly normotensive group. However, other researchers have not confirmed the hypotensive effect of a variety of dietary fibers from fruit, vegetables, or grains.3 4 5 Some water-soluble dietary fibers, such as pure gels and gums, consistently lower serum cholesterol levels.6 7 8 Fibers from mixed sources have less effect,9 10 11 and water-insoluble wheat fiber and cellulose have no effect6 , 12 13 14 on serum cholesterol levels. It has therefore been proposed that water-soluble fibers, but not insoluble fibers, have hypolipidemic properties, in part because they can bind bile acids and promote the excretion of sterols.7 , 15
Oat bran has been studied as a convenient source of soluble fiber.16 Oat bran (100 g per day) lowered serum cholesterol levels by 15 to 19 percent in men with hypercholesterolemia.17 , 18 However, other studies have cast doubt on the existence of an important direct hypocholesterolemic action of oat bran.19 20 21 Two of these studies added oatmeal or oat bran to a standard low-fat diet.20 , 21 In one, serum cholesterol levels decreased 3 percentage points more with the low-fat diet plus oat bran than with the low-fat diet alone.20 In the other, serum cholesterol levels decreased about 4 percentage points less with the low-fat diet plus oat bran than with the low-fat, low-fiber diet.21 Judd and Truswell19 carefully maintained a constant amount of fat in an oat diet and a low-fiber control diet and found no significant difference in serum cholesterol levels. Oat bran could lower serum cholesterol levels by replacing foods in the diet that contain saturated fat and cholesterol rather than by a direct action of the soluble fiber. When oat bran is added to a low-fat diet, the further elimination of saturated fat and consequent lowering of serum cholesterol levels should be minimal.
We designed the present study to investigate directly whether oat bran has an intrinsic hypocholesterolemic action. We compared the effects of a high-fiber diet containing oat bran and a low-fiber diet containing refined wheat. Since the two supplements were similar in energy and nutrients other than fiber, any difference in the resulting serum cholesterol levels could be attributed to the difference in fiber intake, rather than to the replacement of other nutrients by high-fiber foods.
Methods
Subjects
Dietitians and other employees of Brigham and Women's Hospital volunteered to be study subjects. Each prospective subject completed a detailed medical history and had a clinical and laboratory evaluation. Exclusion criteria were hypertension (systolic blood pressure over 150 mm Hg or diastolic blood pressure over 95 mm Hg), hyperlipidemia, use of medications that affect blood pressure or serum lipid levels, and obesity. Twenty-four subjects began the trial. Three dropped out within the first three weeks, and one did not provide a blood sample or dietary information for the final study period. Data from these subjects were not used in the analysis. Twenty subjects, 4 men and 16 women (mean age, 30 years [range, 23 to 49]), completed the trial. Sixteen were dietitians or dietetic interns. All were within the range for desirable body weight as established by the 1959 Metropolitan Life Insurance tables, except for one woman who exceeded the upper limit by 10 percent. Two subjects smoked cigarettes. All the subjects gave informed consent, and the study was approved by the Committee for the Protection of Human Subjects of Brigham and Women's Hospital.
Study Design
The study was a randomized, double-blind, crossover trial with high-fiber and low-fiber periods. During a one-week base-line period, plasma lipid levels, body weight, and blood pressure were measured in each subject. The subjects continued to consume their usual diets. Each participant was then randomly assigned to receive either low-fiber or high-fiber dietary supplements for six weeks. This period was followed by a two-week break during which no supplements were eaten. Finally, the subjects consumed the other type of supplement for another six-week period. The women began each treatment period at the same point in their menstrual cycles, which were regular. None were using oral contraceptives. Nine subjects received the high-fiber supplement first, and 11 the low-fiber supplement.
The supplements were supplied as entrees or muffins (Table 1Table 1
Composition of Dietary Supplements.). All the recipes were developed by members of the dietary staff of the Clinical Research Center, and the supplements were prepared and distributed by the staff of the metabolic-research kitchen. Each type of supplement was prepared in high-fiber and low-fiber versions that were similar in weight, size, other nutrients (Table 1), and seasonings. Muffins and entrees contained oat bran (20 g and 40 g, respectively; Mother's Oat Bran, Quaker Oats, Chicago) or a similar amount of refined low-fiber wheat (Cream of Wheat, Nabisco Brands, El Paso, Tex., and white flour). The high-fiber foods contained approximately 3 g more fat than the low-fiber versions, mainly unsaturated fatty acids from oat bran and corn oil. Both the subjects and the personnel distributing the foods were blinded as to the version supplied. The subjects were asked to eat daily a combination of entrees and muffins that contained 100 g of oat bran or wheat. They kept a daily record of their intake of supplements. The consumption of other foods was unrestricted, and they were selected or prepared by the subjects themselves. The subjects ate the supplements and other foods in the hospital and at home, at their convenience.Measurements
Dietary Intake
Dietary intake was assessed at base line with use of a food-frequency questionnaire, which was analyzed rapidly with an automated, computerized nutrient databank.22 Four-day food-intake records, including one weekend day, were completed during week 5 of the high-fiber and low-fiber study periods. Subjects recorded their intake of supplements and foods they had selected themselves. The records were analyzed with use of the computer program Food Processor II (ESHA Research, Salem, Oreg). Computer entry of the food-intake data was performed by a single dietitian. We compared the intake of nutrients during the high-fiber and low-fiber periods using the four-day records. Changes in nutrient intake from base line were studied by comparing data from the food-frequency questionnaire with data from the dietary records. The comparability of data on dietary fats produced with the two methods has been validated.22 , 23 In two populations studied for one year with use of the food-frequency questionnaire and dietary records, the mean percentage of energy from saturated, monounsaturated, and polyunsaturated fatty acids as assessed by the two methods differed by less than 1 percent, and the daily dietary cholesterol intake differed by 5 and 20 mg per 1000 kcal.22 , 23
Serum Lipids
Blood samples were obtained from an antecubital vein at base line and on the final two days of the high-fiber and low-fiber periods. The subjects ingested nothing but water for 12 to 14 hours before blood sampling. Serum was separated, immediately frozen, and stored at -80°C. At the end of the study, the samples were thawed. Very-low-density lipoprotein was separated from low-density and high-density lipoprotein by preparative ultracentrifugation at 25,000 rpm for 18 hours in a type 25 rotor in a Beckman L8–70M instrument (Beckman Instruments, Palo Alto, Calif.). High-density lipoprotein was separated from serum by precipitation after the addition of dextran and magnesium chloride.24 Cholesterol concentrations were determined by enzymatic methods25 (Boehringer–Mannheim, Indianapolis) in total serum, high-density lipoprotein, and the fraction from ultracentrifugation that contained low-density and high-density lipoprotein. All analyses were performed in one batch. The laboratory is standardized for measurements of cholesterol and high-density lipoprotein by the Lipid Standardization Program of the Centers for Disease Control. Every cholesterol value presented is the mean of two measurements.
Blood Pressure Recorded in the Hospital
Blood pressure was measured at the Clinical Research Center on three days during the base-line period and during weeks 3 and 6 of each study period with use of an automated oscillometric machine (Dinamap, model 845 xT, Critikon, Tampa, Fla.). One instrument was used throughout the study for all the subjects. Measurements were performed at the same time each day in a quiet area after the subject had rested in a sitting position for 5 to 10 minutes. The machine was programmed to take three readings from the right arm at two-minute intervals at each sitting.
Blood Pressure Recorded at Home
The subjects measured their own blood pressure for seven days during the base-line period and during weeks 3 and 6 of each study period. One blood-pressure machine (Lumiscope, Edison, N.J.) was assigned to each subject for the entire trial. The machine automatically inflated the cuff to a pressure 20 mm Hg above the subject's previous systolic reading, and then decreased the pressure by 2 mm Hg per second, printing a record of the date, time, systolic and diastolic blood pressure, and heart rate. Blood pressure was measured in the sitting position, in duplicate, three times a day (morning, late afternoon, and late evening). Each instrument was tested for accuracy against a standard mercury sphygmomanometer as described previously.26
Urinary Measurements
A 24-hour urine collection was obtained during week 5 of the high-fiber and low-fiber periods. Sodium and potassium concentrations were measured with use of a NOVA Analyzer I (NOVA Biomedical, Waltham, Mass.) and creatinine concentrations with use of a Beckman Analyzer II at the core laboratory of the Clinical Research Center.
Weight
Body weight was measured in light clothing without shoes at base line and during weeks 3 and 6 of each dietary period, on one upright scale (Detecto, Webb City, Mo.).
Statistical Analysis
We analyzed differences in serum cholesterol levels and blood pressure in the three study periods — base line, high fiber, and low fiber — by repeated-measures analysis of variance followed by pairwise comparisons, using the Student—Newman—Keuls test.27 The general linear-models procedure of the Statistical Analysis System was used for these analyses.27 We computed the 95 percent confidence intervals for the differences in serum cholesterol levels between the high-fiber and low-fiber periods, using the standard errors of the differences in the least-squares means. A two-tailed paired t-test was used to compare the differences in the intake of nutrients as measured by dietary records during the high-fiber and low-fiber periods.
Results
Intake of Nutrients
At base line, the subjects ate their usual diets, which contained moderate amounts of fat (30.6 percent of energy), cholesterol (274 mg per day), and fiber (23.3 g per day) (Table 2Table 2
Intake of Nutrients and Body Weight during the High-Fiber and Low-Fiber Study Periods.*). The subjects ate 93 percent of the refined-wheat and 87 percent of the oat-bran supplements that were distributed. Intake of the supplements, whether high or low in fiber, caused slight decreases in the subjects' dietary intake of saturated fat and cholesterol and an increase in the intake of polyunsaturated fat. The mean daily intake of energy from the supplements was 864±94 kcal and 944±115 kcal during the high-fiber and low-fiber periods, respectively (P<0.05). Total dietary fiber increased from 18.4 g per day during the low-fiber period to 38.9 g per day during the high-fiber, oat-bran period (P<0.001). Dietary fat was significantly higher during the oat-bran period than during the wheat period (P<0.001). Most of the increase in dietary fat was due to the linoleic and oleic acids in oat bran and corn oil. There were no significant differences between the treatment periods in the intake of cholesterol. Body weight (Table 2) remained stable throughout the study. The total intake of energy was lower in the base-line period than during the supplementation periods. Since physical activity and body weight did not change, the difference in the reported energy intake may have been the result of the different methods used to assess dietary intake.Blood Pressure
The average systolic and diastolic blood pressure as measured in the hospital was 112/68 mm Hg at base line and did not change during either period of dietary supplementation. The average blood pressure as measured in the subjects' homes was 110/67 and 107/65 mm Hg during the high-fiber and low-fiber periods, respectively (P = 0.3). The study had a power of 80 percent to detect a significant (P<0.05) effect of oat bran on hospital-recorded blood pressure of 2.6 mm Hg systolic and 2.1 mm Hg diastolic, with use of the standard deviations of the changes in blood pressure between the high-fiber and low-fiber periods.
Serum Cholesterol
The mean serum cholesterol level decreased significantly from base line during both the high-fiber and low-fiber dietary periods, by 7.5 percent (95 percent confidence interval, 3.5 to 11.5 percent) and 7.1 percent (3.1 to 11.0 percent), respectively (Table 3Table 3
Serum Lipoprotein Cholesterol Levels before and during High-Fiber and Low-Fiber Dietary Supplementation.*). Low-density lipoprotein cholesterol levels also decreased significantly on both the high-fiber and low-fiber diets, by 9.1 percent (4.4 to 13.9 percent) and 6.4 percent (1.7 to 11.2 percent), respectively. We used the equation of Keys and his colleagues,28 derived from dietary experiments on a metabolic ward, to determine to what extent the decreases from base line in dietary saturated fat and cholesterol levels and the increase in polyunsaturated fat, taken together, could explain the decline in serum cholesterol levels from base line. The Keys equation predicted a decrease of 0.34 mmol per liter (13 mg per deciliter) during the high-fiber period and 0.31 mmol per liter (12 mg per deciliter) during the low-fiber period. Both predicted values were within 0.03 mmol per liter (1 mg per deciliter) of the actual decrease. There was no significant difference in levels of total cholesterol, low-density lipoprotein, high-density lipoprotein, or very-low-density lipoprotein between the high-fiber and low-fiber periods (P>0.05). There was a trend for the high-density lipoprotein level to be lower on the low-fiber diet than on the high-fiber diet, possibly because the total fat intake was lower during the low-fiber period.29 30 31 The 95 percent confidence intervals for the differences in serum cholesterol and low-density lipoprotein levels between the low-fiber and high-fiber periods were -0.20 to 0.17 mmol per liter and -0.22 to 0.06 mmol per liter, respectively. These intervals include possible hypocholesterolemic effects of fiber of 4 percent for total cholesterol and 8 percent for low-density lipoprotein. In the subjects who had serum cholesterol levels in the upper half of the distribution (4.7 to 7.0 mmol per liter [183 to 270 mg per deciliter]), the difference between serum cholesterol levels during the two treatment periods was -0.04 mmol per liter (-1.5 mg per deciliter) (P not significant). There was no evidence of a carry-over (order) effect between treatment periods.Urinary Measurements
Urinary measurements (means ±SD) during the high-fiber and low-fiber periods, respectively, were as follows: sodium, 103±38 and 118±50 mmol per day; potassium, 60±19 and 58±19 mmol per day; and creatinine, 1.24±0.28 and 1.25±0.26 g per day. None of the differences were significant.
Side Effects
After the trial was completed, the subjects were questioned about side effects and asked to guess the order of the supplements. The high-fiber period was identified by 18 of the 20 subjects, mainly because of the gastrointestinal reactions, such as flatulence, cramping, bloating, loose stools, and diarrhea, experienced by 15 subjects. One subject reported a gastrointestinal reaction (constipation) during the low-fiber period.
Discussion
The present study was conducted to determine the effect of oat bran on serum lipoprotein cholesterol levels and blood pressure in a free-living population of healthy persons. Oat bran did not significantly lower serum cholesterol levels or blood pressure any more than did an isocaloric dietary supplement of refined low-fiber wheat. The design of the study, a randomized, double-blind, crossover trial, was intended to overcome the limitations of other designs previously used. Studies that lacked a low-fiber control group could have found a cholesterol-lowering effect that resulted from the replacement of foods that contained saturated fat or cholesterol or from nonspecific influences, rather than from the fiber itself.32 Subjects in studies that were not conducted blindly could have adjusted their intake of other nutrients or other aspects of their lifestyles that affected blood pressure or cholesterol.20 , 21 The crossover design of the present study, in which subjects served as concurrent randomized controls, was intended to minimize nonspecific effects and confounding from changes in the intake of foods other than oat bran and refined wheat. Oat bran contains, in addition to fiber, more fat than refined wheat. However, since the fat had twice as much polyunsaturated as saturated fatty acids, no alteration in serum cholesterol or low-density lipoprotein cholesterol levels would be expected from the fat content of oat bran.28 It is possible that oat bran in the amount that we used has a small cholesterol-lowering effect (4 percent) that was not detected in this study. Such a small decrease in response to such a large daily intake of oat bran is unlikely to be important in a practical sense, particularly in view of the uncomfortable gastrointestinal reactions produced.
Fiber and Blood Pressure
Initially, Wright et al.2 found that wheat fiber (29 g per day) or fiber from various sources lowered blood pressure in normotensive men. However, other researchers have not confirmed a hypotensive property of wheat or other sources of fiber. Kelsay et al.3 found that a high-fiber diet of whole fruits and vegetables did not lower blood pressure as compared with a low-fiber diet containing fruit and vegetable juices. Brussaard et al.4 compared a low-fiber diet with three different high-fiber regimens — containing fruits and vegetables, isolated citrus pectin, and coarse wheat bran — and found no hypotensive effect of any of the fibers. These reports3 , 4 also suggest no advantage of soluble as compared with insoluble fiber in lowering blood pressure, since wheat bran has little soluble fiber as compared with the other supplements used. Margetts et al.5 studied a diet high in fiber from various sources that was designed to resemble the high-fiber component of a vegetarian diet. As compared with a low-fiber control diet, the high-fiber diet did not significantly lower blood pressure.
This study also does not support a role for dietary fat in the control of blood pressure, since there was no decrease in blood pressure when the intake of dietary fat decreased during the supplementation periods. Most previous studies have not found significant effects of dietary fats on blood pressure.33 It is important to remember, however, that our subjects were normotensive; it is possible that hypertensive patients might respond differently.
Fiber and Serum Cholesterol Levels
From previous reports on patients with hypercholesterolemia, we expected that oat bran would decrease serum cholesterol levels as compared with the low-fiber refined wheat.17 , 18 For example, Kirby et al.17 found that oat bran (100 g per day) lowered serum cholesterol levels by 13 percent as compared with a low-fiber diet. But in the present study of subjects with normal lipid levels, oat bran and low-fiber refined wheat had similar effects. Both supplements significantly lowered serum cholesterol levels from base-line values, by 7.5 and 7.1 percent, respectively. During both periods of supplementation, the subjects ate less saturated fat and cholesterol and more polyunsaturated fats than at base line. The Keys equation28 predicts from these changes in the intake of dietary fats a decrease in serum cholesterol levels that is nearly identical to the decreases we observed. These findings suggest that supplements high in complex carbohydrates, whatever their fiber content, replace fatty foods that raise serum cholesterol levels, and that oat bran may not have specific hypocholesterolemic properties.
Other studies are compatible with this interpretation. De Groot et al.32 found that serum cholesterol levels decreased by 11 percent in 21 subjects with hypercholesterolemia who ate 140 g of oatmeal per day. This result could have been caused by the replacement of fatty foods, since there was no control group with a low-fiber diet. Other researchers compared the effects on serum cholesterol levels of oat bran (100 g per day) or dried beans (115 g per day) containing similar amounts of plant and soluble fiber.18 Serum cholesterol levels decreased by 19 percent and low-density lipoprotein levels decreased by 23 to 24 percent with both the oat-bran and bean diets. Again, since there was no randomized low-fiber control group, this study suggests only that oat bran and beans are equivalent, not that either oats or beans have direct cholesterol-lowering properties. Van Horn et al.20 studied 208 healthy volunteers who followed an American Heart Association modified-fat diet for six weeks and then added oat bran (39 g per day) or oatmeal (35 g per day) for another six weeks. The modified-fat diet caused a 5.2 percent reduction in serum cholesterol levels. The addition of oat bran or oatmeal resulted in a further 3 percent reduction in serum cholesterol levels (two-sided P value <0.10). Since the study did not use a low-fiber control supplement, the slight decline in cholesterol levels could have been caused by replacement. Demark-Wahnefried et al.21 found that a low-fat diet plus oat bran (50 g per day) produced no significant lowering of serum cholesterol levels beyond that achieved with the low-fat diet without oat bran. Perhaps when the intake of dietary fat and cholesterol is low, there is little of these nutrients left for fiber to replace. Therefore, we conclude that oat bran has little inherent cholesterol-lowering action in persons with normal serum cholesterol levels.
It is possible that patients with hypercholesterolemia are more responsive than healthy subjects to oat bran. The present data give no support to this concept, since the serum cholesterol levels of the subjects in the upper half of the cholesterol range showed no tendency to decrease with oat bran as compared with wheat. There is no precedent for nutritional changes to be selectively effective in persons with hypercholesterolemia. Decreases in dietary fat and cholesterol cause serum cholesterol levels to decline by a similar percentage in persons with levels in the upper or lower portion of the range.28 , 34 The clinical usefulness of oat bran in patients with hyperlipidemia, even if a true effect on serum cholesterol levels is confirmed in controlled trials, would seem to be limited by the large amounts of oat bran that would be needed (more than 100 g per day17 , 18), the likely adverse gastrointestinal effects, and the monotony of the overall diet needed to provide such a high daily intake of oat bran.
The present study suggests that persons with normal or elevated serum cholesterol levels will benefit from diets that are rich in oat bran if their dietary fat intake decreases to compensate for the calories of the oat bran. As we also found, low-fiber products can achieve the same result with fewer gastrointestinal side effects.
Supported by a grant (HL34593) from the National Heart, Lung, and Blood Institute and a Clinical Research Center grant (M01-RR02635) from the National Institutes of Health. Dr. Sacks is the recipient of an Established Investigator Award from the American Heart Association, and Dr. Rouse was a Neil Hamilton Fairley Fellow of the National Health and Medical Research Council of Australia.
We are indebted to Ray Gleason, Ph.D., for statistical consultation, to Gregory Krukonis and Cory Lenherr for lipoprotein measurements, and to the staff of the metabolic-research kitchen.
Source Information
From the Channing Laboratory, Department of Medicine, and the Clinical Research Center, Brigham and Women's Hospital, and Harvard Medical School, Boston. Address reprint requests to Dr. Sacks at 180 Longwood Ave., Boston, MA 02115.
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