Appendix 3 – Characteristics of included studies Reference Study design Objectives Participants & sample size Interventions Methods Confounders Results Notes Abrahamsson 1994 Comparison of effect between oat and wheat fibre on cholesterol metabolism in healthy women 31 healthy females aged 20-46 y, majority with normal cholesterol. 27 included in final analysis. made with oat or wheat bran. 7d food records for compliance and food intake. Average -glucan intake 7.5g per day in oat group, 1.1g per day in wheat group. 1wk run-in period then 2x 5wk periods. Compliance and dietary intake by 7d weighed food records. Lipids measured by enzymatic assay. LDL-C measured directly. ANOVA analysis Controlled by design and measured by food intake. Non-significant decrease in total, LDL-C, and Dietary intakes well-matched between strata. Amundsen 2003 Assess effects of addition of oat bran concentrate to a low saturated fat and cholesterol diet. 20 subjects (56% men) with hypercholesterolaemia. 16 completed study. Whole diet provided, prepared with oat bran concentrate or placebo diet. Test diet provided 5 g (2.7 g soluble) -glucan per day. 2x 3wk periods with 2.5wk washout. 7d food record for baseline dietary intakes, food for consumption of test and non-test foods. LDL-C calculated. t-test analysis Minimised by design and provision of all foods. Significant decrease in and LDL-C, decrease in Power calculation performed for total cholesterol.
Biorklund 2008 Parallel To assess the effects of consuming in a ready to eat meal on blood lipid and postprandial glucose and insulin response. 43 healthy participants with mild hypercholesterolaemia (44% male). 4g -glucan as a soluble oat fibre concentrate consumed daily as a soup. 3wk run in, 5wk test period. Compliance by daily recording of soup intake. Dietary intake by 3d. Blood lipids by standard techniques, calculated. ANOVA analysis Statistical analysis by t-test. Groups well matched at baseline. Non-significant decrease in total cholesterol, and HDL-C. calculation for change in LDL performed. Braaten 1994 – To determine whether -glucan is responsible for the effect of oat bran. 20 free-living hypercholesterolaemic participants (47% male). 19 completed study. -glucan as or maltodextrin placebo, was consumed twice daily in a drink. Subgroup analyses performed on “responders” vs. “non-responders”. 1-3wk run-in, 2x 4wk intervention with 3-4wk washout. Compliance by returned packets. Dietary intake by 3d food record in first 2wk of each intervention period. Blood lipids measured by automated method, LDL-C calculated. ANOVA and t-test analysis. Controlled by cross-over design. Some differences in fat and cholesterol intake between oat and placebo phase. Significant decrease in total cholesterol and LDL-C Baseline lipids calculated from pooled values of pre-test, placebo and placebo wash-out phase. Data for placebo groups presented in graph only. Bremer 1991 To compare lipid-lowering effects of oat compared to wheat bran. 12 participants aged 38-66 (42% male) with hyperlipidaemia and stable consumption of a lipid-lowering diet Participants consumed bread with oat or wheat bran, average oat bran intake 45/day. 2wk run in with 2x 4wk interventions separated by a 2wk washout. Dietary intake, including bread, recorded daily. Blood lipids measured by standardised techniques with LDL-C calculated. Paired t-test analysis. Controlled by cross-over design and daily measurement of food intake. Non-significant decreases in total cholesterol and LD-C. HDL-C increased in both groups, but was relatively decreased in oat group.
Chen 2006 Parallel To test the effects of soluble from oat-bran on blood lipids in people with normal blood cholesterol concentration. 110 healthy adults (40% male, aged were randomised, 56 to control group and 54 to intervention. 102 completed the study (52 in control, 50 in intervention) Intervention group consumed oat bran concentrate in muffins and oatmeal cereal to give 7.3g -glucan per day. Control group consumed low fibre wheat muffin and corn flakes. 2wk run in then 12wk intervention. Compliance by daily records and returning unused packets. Dietary intake by 24hr recall. Blood lipids by standard techniques, calculated. ITT performed, comparisons by ANOVA and paired t-test. Randomisation stratified by gender and ethnicity, but oat was older (3.6 year, p=0.03) and had 26% higher baseline dietary fibre intake. Non-significant decreases in total, LDL-C and HDL-C cholesterol. Similar GI symptoms reports in both groups. Cugnet-Anceau 2010 Parallel To test the effect of enriching a normal diet with -glucan on glucose control and blood lipids in diabetics. 67 diabetic subjects randomised (60% male, aged 30-75, 50% on lipid-lowering medication). 53 completed the trial, 24 in control, 29 in intervention. Soluble oat concentrate or placebo consumed in a soup once a day. 3wk run-in then 8wk intervention. Compliance by returning unused packets, dietary intake by 5d food intake questionnaire. Blood lipids by standard techniques, LDL calculated. Unpaired t-test or Mann Whitney U test used. Dietary intakes not well matched. 21% participants withdrew, but distribution of withdrawals was not reported. Non-significant changes in total, LDL and HDL cholesterol. Power calculation performed for glucose marker. Thorough assessment, including blood analyses, found no serious adverse effects.
Davidson 1991 Parallel To test the effects of increasing amounts of oatmeal and oat bran consumed in combination with a NCEP Step 1 diet. 211 participants with borderline or high enrolled in diet stabilisation phase. 156 “diet stable” subjects randomised. 148 completed study, 140 included in per protocol analysis. 6 oat groups with 20-23 subjects, control group 15 subjects. Intervention groups consumed 28g, 56g or 84g of oatmeal or oat bran per day to give 1.2. 2.4, 3.6, 2.0, 4.0, 6.0g respectively. Control consumed 28g farina (low fibre cereal). 8wk run-in, 6wk intervention followed by 6wk washout. Compliance by recording and return of unused packets. Dietary intake by 4d food records. RMANOVA Blood lipids by standard techniques, calculated. Per protocol analysis reported, ITT gave similar results. Baseline dietary fibre appeared systematically different, with higher baseline levels in participants assigned to higher -glucan consumption. Significant decreases in total and LDL-C in groups consuming 56g and 84g oat bran, and 84g oatmeal. increase in No clear for and cholesterol. calculation performed for total cholesterol. Davy 2002 Parallel To compare the effects of 2 large serves per day of oat or cereals on blood lipids and lipoproteins. 39 overweight men (age 50-75, BMI 25-35) participated, 36 completed the study but lipid data reported for 35 (17 oat, 18 wheat). Oat group consumed 60g oatmeal and 76g oat bran cereal per day to give 5.5g -glucan. Wheat group consumed 60g whole wheat hot cereal and 81g frosted wheat cereal per day. 12wk trial. Compliance by returning uneaten cereal, dietary intake by 4d food records. Lipids measured by nuclear magnetic resonance. Groups poorly matched for baseline saturated fat and fibre intake. Large differences in reductions in dietary cholesterol intake between groups. Non-significant decrease in total cholesterol and increase in Significant decrease in Total and LDL-C increased in wheat group.
1990 Parallel To compare the effects of addition of oat bran to a low fat low cholesterol (NCEP) diet. Adults (aged 20-65, %men unclear) with hypercholesterolaemia. 81 subjects assigned to 4 groups, 68 completed study. In analysis, 18 in oat bran group and 15 in control group. All subjects followed and NCEP step 1 diet. Oat group consumed 50g unprocessed oats. 2wk run-in, then 12wk trial with follow-up every 4wks. Compliance by returning unused packets and food records. Dietary assessment of 3d food records at baseline and 3 times during intervention. Lipid analysis by standard methods (note no LDL-C data) RMANOVA analysis. Large differences in baseline saturated fat and fibre intakes at baseline. Non-significant increase in total cholesterol. No LDL-C data and HDL decreased in both groups (only reported graphically) 4 study strata, regular diet with oat bran, regular diet with processed oat bran, low fat low cholesterol diet or low fat low cholesterol diet with oat bran. Addition of oat bran to a regular diet was not included as no adequate control groups for these strata. Gerhardt 1998 Parallel To compare the effects of oat bran and rice bran for the treatment of hyperlipidaemia. In oat bran and rice starch placebo groups: 33 moderately hypercholesterolaemic adults (52% male).Final analysis of 30 adults, 13 in oat bran and 17 in rice starch placebo. Subjects consumed 84g/d of oat bran (3.3g soluble fibre) or placebo (84g/d of rice starch) in addition to usual low-fat diet. 6wk trial. Compliance by returning unused packets, dietary intake by weekly food records. Blood lipids measured in pathology laboratory, LDL-C calculated. ANOVA with analysis. Differences in baseline SFA and fibre intake. Significant decrease in total cholesterol and LDL-C. No difference in Rice bran not considered in analysis. GI symptoms in oat bran group reported.
Kashtan 1992 Parallel To compare oat bran effect on blood lipid in adults with previous polypectomy and those without such history 84 adults aged 61.3years, 31 men and 14 women, with normal blood lipid levels Oat bran (88g/day) or wheat bran supplement (73g/day), twice per day. Taken with hot or cold cereal, at both breakfast and dinner. Wheat bran diet was supplemented with cream of wheat and cheddar cheese, in order to match nutrient profile. Compliance by comparing consumed foods composition according to the subjects’ records with prescribed diets provided. t-test analysis and ANCOVA adjusting baseline values and gender. On average, the 84 participants consumed 91% of dietary calorie. 43 participants consumed 90% of designated supplement and diet and results include only those. Significant decrease in total and LDL cholesterol in oat consuming treatment compared with wheat. No change in HDL. Keogh 2003 To test the effects of a highly -glucan enriched barley on markers of CVD risk. 18 mildly hypercholesterolaemic and overweight men (aged 18-65y). diet provided containing highly enriched b-glucan from barley in a variety of foods. Treatment stratum consumed -glucan/d. Control consumed isoenergetic amount of 6.5-9.2 g glucose/d. 2x 4wk periods, minimum 4wk washout. Compliance by urinary nitrogen measures. Unclear method of blood lipid measurement. ANOVA and t-test analysis. Minimised by cross design and provision of total diet. Total cholesterol and LDL-C fluctuated throughout intervention period, no significant difference observed. Data presented as least square means.
Kerckhoffs 2003 Parallel To test the effect of -glucan from oat bran in goods on serum lipids and lipoproteins. 51 mildly hypercholesterolaemic adults (44% male, 48 completed study. Oat bran and oat bran concentrate administered in bread and cookies to give daily intake 5.9g -glucan. Subgroup analysis performed for gender. 3wk 4wk intervention. Compliance by recording daily intake of test foods. Dietary intakes by FFQ. Blood lipids measured enzymatically, LDL-C calculated. ANOVA and t-test analysis, gender subgroup analysis. Groups at baseline. No significant changes in lipid profile. No effect of gender. Power calculation performed for LDL-C. Kestin 1990 To test the effect of different cereal brans on blood lipids and lipoproteins as well as measures of glucose and insulin and stool frequency. 28 mildly hypercholesterolaemic men (aged 29-61). 24 completed study. Low fibre diet supplemented with bread and muffins made with oat, wheat or rice bran. Wheat bran selected as control group. Oat group consumed 95g containing 5.8g of water soluble fibre. 3wk low fibre run-in then 3x 4wk intervention periods. Compliance by food intake diary and weighed food records. Dietary intake by 4d weighed food records in each period. Blood lipids measured using automated methods, LDL-C calculated. ANOVA and t-test analysis. Minimised by cross-over design Significant decrease in and LDL-C. difference in and TG.
Leadbetter 1991 To test the effect of consuming different quantities of oat bran on blood lipids. 40 mildly hypercholesterolaemic subjects (50% male, 25-64y). 2 subjects withdrew but were replaced. Addition of 0, 30, 60 or 90g per day oat bran to regular diet. 4 x 1mo periods in Latin square design. Compliance by returning unused sachets. Dietary intake by 5d food record before and 1d food records during each intervention period. Blood lipids measured enzymatically, LDL-C calculated. RMANOVA analysis. Minimised by design No significant difference on total cholesterol, or HDL-C. Significant, negative correlation between oat bran amount and Lepre 1992 To determine if adding oat bran to a low saturated fat, low cholesterol diet had additional effects. 37 mildly hypercholesterolaemic subjects (43% male, 28-69y). 30 completed study. Subjects consumed a low saturated fat, low cholesterol diet, with 2 muffins per day containing either 60g oat bran (3.2g soluble or 60g wheat bran. 3x 8wk periods (diet only, oat muffin or wheat muffin) Compliance by diet review and 4 x 1 day food records in last 4 of study. Dietary intake by 4 x 1 day weighed food records (1 day/week for last four weeks of each period). Blood lipids measured, LDL-C calculated. Statistical analysis by variance and Minimised by cross-over design. Small but statistically significant differences in some nutrient intakes between intervention periods. Significant decrease in non-significant decrease in cholesterol. Minor GI symptoms in some subjects (unclear in which intervention)
Li 2003 To test the effect of barley intake on blood lipids and glucose in healthy young Japanese women. 10 healthy females (mean age 20.4). Cholesterol status unspecified but baseline value indicates normal cholesterol concentration. Whole diet provided, in test phase 30% of carbohydrates replaced with barley as wholegrain (45% barley bran). 2x 4wk intervention with 4wk washout. Compliance not reported but all meals were provided. Blood lipids measured using commercial kits, LDL-C calculated. RMANOVA and analysis. Minimised by cross-over design. Saturated fat intake not reported, but total fat intake similar. Significant decrease in total cholesterol and LDL-C. No change in HDL-C. No side effects of intervention. Lupton 1994 Parallel To test whether adding barley bran or barley oil to a NCEP diet enhances 79 hypercholesterolaemic subjects (45% male). 53 subjects in 2 relevant strata of trial. All subjects consumed NCEP step 1 diet. One group consumed 30g of barley bran flour (70% fibre) provided as a supplement. Control group consumed 20g of cellulose. 30d intervention. Compliance unclear. Dietary intake by 3d dietary records. Blood lipids measured enzymatically, LDL-C calculated. ANOVA and t-test analysis. Barley bran group had significant decreases in energy, cholesterol and fat intake, whereas control group only reduced total fat intake. Blood cholesterol concentration tended to be higher in barley compared to control group. Significant decrease in cholesterol, HDL-C, apoA and apoB. difference in TG. Barley oil stratum of not considered further.
Ma 2013 Parallel To investigate the effects of naked oats on people with Type 2 diabetes using a randomised controlled trial. 119 volunteers (mean age 59 yrs) with metabolic syndrome and Type 2 diabetes but normal cholesterol concentration (43% male). The control group received structured dietary intervention including intensive nutrition education and systematic meal plans. The experimental group received the same diet advice and meal plans with the addition of 50 g/day of naked oats (2.5 beta glucan/day) replacing other staple products such as rice, wheat flour, corn and millet. 1wk run in, 30 day experiment. Food intake and compliance recorded. Venous fasting blood samples were taken. Total and HDL-C were analysed using the enzymatic method, and was calculated. X2 tests and ANOVAs were used for between group comparisons. Relatively low attrition rate, statistical analysis showed no effect of experimental treatment on dropouts. Significant decrease in total and LDL-C following naked oat intervention. No significant change in in Maki 2003 To assess the clinical efficacy of consuming in cereals in blood cholesterol concentration in children. 29 hypercholesterolaemic children (6-14y, 72% male). 18 completed study per protocol. Weight loss diet (NCEP Step 1 dietary guidelines) with 2 portions of b-glucan containing cereal (3g of soluble fibre) or low fibre cereal per day. 4wk run-in, 1wk baseline, then 2x 4wk test periods. Compliance by return of unused packets. Dietary intake by 3d diet record at baseline and in each test period. Blood lipids measured in certified pathology laboratory, LDL-C calculated. Subgroup analysis by BMI. RMANOVA analysis. High attrition. Significantly lower energy intake in -glucan treatment period. Significant decrease in in per-protocol analysis, but not ITT. decrease in total cholesterol and HDL-C. Change in LDL-C significant in subjects below, but not above, median BMI.
Momenizadeh 2014 Parallel Assess the effects of containing oat bran on serum lipid levels in patients with 60 participants (mean age 51 yrs) receiving statins for hypercholesterolaemia (35% male) All participants received hypocaloric diet. Controls received min 5 servings/day bread (150g/day) whilst experimental group received 150g/day oat bran bread (6g/serving beta glucan, 30g beta glucan/day). 2wk run in, 4wk intervention Fasting samples were used to determine total, LDL-C and HDL-C, which were measured with an Autoanalyser. Between group differences calculated using Student’s t test, paired t tests for before and after comparison. Numerical reductions in and LDL-C following oat bran bread, but not significantly different to reductions in wheat bread group. Unclear reporting of statistical calculations and effects. Newman 1989 Parallel To compare the effects of consuming made from barley flour compared to isofibrous wheat foods on blood cholesterol concentration. 14 male volunteers aged >35y. Serum cholesterol status prior to study was not a consideration. Participants from the barley consumed 42g of fibre from cereal and baked goods made with barley flour (12g 8g Control foods were made with wheat flour and bran to match fibre content. 4wk intervention. Compliance and dietary intake by 3d dietary recall at baseline and end of intervention. Blood lipids measured enzymatically, LDL calculated. Statistical analysis by linear regression. Groups poorly matched for baseline fibre and fat intake, but intakes similar during intervention. No significant changes in profile. Cholesterol appeared to increase in wheat group. Both groups reported mild GI side effects.
Noakes 1996 (2 strata) To compare the effects of a diet enriched in low or high amylose starch, or oat bran, on blood glucose, insulin, lipids and bowel function. 23 overweight hyperlipidaemic subject. 10 females (45-61y) and 13 males (44-64y). considered as 2 trials; 1 in men and 1 in women Participants consumed bread, cereal, pasta, muffins made with oat bran or high amylose starch on a low fat low fibre background diet. Females consumed 87g oat bran and males consumed 121g oat bran. 3x 4wk intervention. Compliance by daily food records. Dietary intake by 3d weighed food records during each period. Blood lipids measured enzymatically, LDL-C calculated. RMANOVA and analysis. Minimised by cross-over design. No significant change in cholesterol concentration. High amylose stratum selected as control as it provided a better of fibre intakes. The low amylose stratum was not considered further. Onning 1999 To study the properties of an oat milk deprived of insoluble fibre in men 66 men with moderate hypercholesterolaemia (mean age, 62.6y). 52 men completed the study. Participants consumed 0.75L oat milk/day with a daily -glucan intake of 3.825g. Controls drank equivalent volume rice milk. 2 x 5wk intervention with 5wk washout period. Blood lipids measured using automated analyser, LDL-C calculated. Analysed using paired t tests and Wilcoxon nonparametric tests (lipid values were not normally distributed) Minimised by cross-over design. Compliance and dietary intake information not recorded. High attrition due to unwillingness to continue. Significant decreases in total cholesterol and LDL-C. No change in HDL-C. Taste and sensation of milks were tested; participants could not tell them apart.
Pick 1996 To test the long term effects of oat bran concentrate product on diabetes control. 8 diabetic men Participants consumed oat bran concentrate in and bread products with a mean intake of 9g soluble fibre. Control products were white bread. 2x 12wk periods. Compliance by 3 weekly appointments including 48hr recalls. Dietary intake by 4x 48hr recalls in each intake period. Blood lipids measured enzymatically, LDL-C calculated. RMANOVA analysis. Minimised by cross-over design. Difference in test products bread vs. variety of bread products) may introduce confounding. Significant decreases in total cholesterol and LDL-C. No change in HDL-C. Intervention was well tolerated. Poulter 1994 To test the effect of cereal on blood cholesterol in a group representative of the general population. 64 participants (29% male) mean age 56y. Majority of participants were recruited from a hypertension clinic and not selected on blood lipid status. Participants in the oat group consumed a mean intake of 56g of commercially available oat based cereal per day (2.24g soluble fibre). 2x 4wk period. Compliance by returned cereal and weighing of unused cereal. Dietary intake by 2d food diary at baseline and end of intervention. Blood lipids measured enzymatically, LDL-C calculated. Statistical analysis by t-test and a method for trials. Dietary fat intake and polyunsaturated: saturated fat ratio fluctuated throughout trials Significant decrease in cholesterol and LDL-C. No change in HDL-C. Amount of soluble fibre consumed by oat group unclear (reported as 2.24g, but when calculated from information in paper amount is 3g per day).
Saltzman 2001 Parallel To determine whether w weight loss diet with oats would have addition benefits on blood pressure and lipid concentration compared to weight loss alone. 43 adults (47% male, 19-30y in younger group and 64-78 in older group). BMI Not selected for lipid status (mean values normal). Whole diet provided, weight loss diet +/- 45g oats per day. Quaker quick oats incorporated into wide range of foods and were consumed at every meal. 2 week weight stabilisation followed by 6 week weight loss phase with or without oats. Compliance and dietary intake by provided diet. Weight loss in accordance with predictions also indicated compliance. Blood lipids measured enzymatically, LDL-C calculated. ANCOVA and analysis. Groups generally well matched. Similar weight loss between groups. Significant decrease in cholesterol and LDL-C. increase in Designed to allow comparison between older and younger ages, and body weight classifications, but data not reported Sundberg 2008 To determine the effects of soluble fibre in a commercial barley product on risk markers for CHD, namely LDL-C, HDL-C and total cholesterol 44 adults (30% male) with elevated LDL-C (>3.2 mmol/L) between the ages of 20 and 75 years (mean 63.4 years) Intervention consisted of 60g/day barley fibre flakes (3.06g/day Placebo group received 60g/day of wheat flakes with cellulose. No 2x 4 wk intervention with 4 wk washout. Compliance by daily recording of test food intake and returned packages (>97%). Dietary intake with 3 d food records. Blood analysed according to standard procedures at Centre for Laboratory Medicine, Uppsala., Sweden. Differences analysed with paired t-tests. Groups well matched for diet during the interventions, but no data regarding usual diet prior to intervention. Higher concentration of insoluble dietary fibre recorded during the placebo treatment. Significant decreases in total cholesterol and LDL-C. Equal numbers of adverse events (gastric problems) recorded for each intervention.
Swain 1990 To compare the effect of oat bran and low fibre refined-wheat product on blood cholesterol concentration. 24 dietitians and hospital employees (20% male, 23-49y). Normal cholesterol concentration. 20 completed study. oat bran group consumed muffins and entrees containing oat bran to give 100g oat bran per day (86% compliance). Control group received placebo foods made with refined low-fibre wheat. 1wk run-in, 2x 6wk intervention with 2wk washout. Compliance by recording of test food intake. Dietary intake by 4d food records in week 5 of intervention. Blood lipids measured enzymatically, LDL-C measured directly. RMANOVA with test. Total and saturated fat intake higher during test phase. No significant difference in blood cholesterol concentration. GI symptoms enables subjects to correctly identify intervention Theuwissen 2007 To compare the effects of intake alone or in combination with and plant stanol esters on blood lipid concentration and lipid metabolism. 43 mildly hypercholesterolaemic participants (48% male, 18-65y). 42 completed study, but 2 excluded from analyses. Muesli with fibre (control) or from oat fibre was consumed 2x daily at least 5 hours apart. Mean intake was 4.8g per day in the oat group. 3x 4wk intervention with 2wk washout. Compliance by returned packages and record of any protocol deviations. Dietary intake by FFQ at end of intervention phases. Blood lipids measured enzymatically, LDL-C calculated. ANOVA with Tukey post-hoc analysis. Minimised by cross-over design Significant decrease in total cholesterol and LDL-C. No change in HDL-C. Power calculation for LDL-C. 2 subjects were excluded due to elevated liver enzymes throughout study (including control period). Intervention of combined of and sterols was not considered.
Thongoun 2013 Assess the impact of consuming oatmeal on lipid profiles in adults in Thailand 24 hypercholesterolaemic participants (8% male, mean age 51 yrs). Test participants consumed 70g/day instant oatmeal (3g beta glucan/day). Controls ate 70g/day rice porridge. 1wk 4wk intervention (possible 1 wk washout, wording unclear) Total cholesterol, LDL-C and HDL-C were measured in fasting blood samples before and after each intervention. Compliance was assessed using 2 x 3d dietary records. ANOVA used to analyse data. During the control intervention, intake of CHO increased whilst fat decreased. Significant decreases in cholesterol and LDL-C following oat intervention. Torronen 1992 Parallel To assess the effect of consuming bread made with oat bran concentrate on blood lipid concentration. 30 adult males 28 completed study, 13 in oat group and 15 in control group. Test group consumed oat bran concentrate bread to give 5.6g -glucan for first 2wk increasing to 11.2g -glucan for next 6wk. Control group consumed bread giving 0.3g per day. 2wk run-in, 8wk intervention with increase in time, 2wk follow-up. Compliance by intake records. Dietary intake by 3x 3d food records (baseline, during and after intervention). Blood lipids measured enzymatically, LDL-C measured directly. MANOVA and t-test analysis. decrease in saturated fat intake during oat intervention leading to lower saturated fat intake during intervention. Non-significant decreases in cholesterol, or HDL-C. Significant increase in TG and VLDL-C observed in oat group.
Van Horn 1991 Parallel To test the effect of consuming moderate amounts of instant oats on concentration as well as to assess dietary adaptations to the daily inclusion of oats. 111 hypocholesterolaemic adults (50% male, 80 completed study. 56g instant oats isocalorically substituted into regular diet (recorded consumption 54g). Subgroup analyses by baseline cholesterol, gender and BMI. 8wk trial period. Compliance by food records. Dietary intake by 3d food record at baseline, 4 and 8wks. Blood lipids measured enzymatically, LDL-C calculated. Statistical analysis by t-test. High attrition. Baseline characteristics of groups well matched at baseline. Saturated fat intake changes significantly between groups, with decreased intake in intervention but increased intake in control group. Non-significant decrease in cholesterol and LDL-C. . No side effects reported from oat intake. Vortser 1986 To compare the acceptability and some biochemical effects of a new oats fibre tablet to a similar amount of wheat bran. 18 healthy undergraduate volunteers. 6 men and 12 women (mean age 20y). Normal cholesterol values. 15g oat fibre tablets (15 x 1g tablets). Wheat bran tablets as control. 2 x 3wk intervention, with 4wk washout period. Habitual food intake recorded at baseline. Blood lipids measured enzymatically, LDL-C measured directly. Blood glucose tested, as well as ease of intake of supplements. RMANOVA, ANCOVA and analysis. Minimised by cross-over design and provision of tablets. Compliance and dietary intake through intervention not recorded. No change in blood glucose. Oat and wheat supplements lowered total cholesterol and LDL-C in the first intervention period; only oat supplements lowered them in the second. Study reported each period of cross-over as separate experiment. When combined, there were no significant effects of oats on total cholesterol or LDL-C. Oat supplements were easier to take than wheat, with fewer side effects.
Braaten 1994 ? Method not stated ? Not described high Participants blinded, but correctly identified phase ? Not stated low 5% attrition low Expected outcomes reported low Bremer 1991 ? Method not stated ? Not described low Participants blinded, not personnel ? Not stated low no attrition low Expected outcomes reported low Chen 2006 ? Stratified by race and gender, method unclear low Opaque envelopes low Double blind low blinded low 7% attrition low Expected outcomes reported low 2010 ? Method not stated ? Not described low Double blind ? Not stated high 21% attrition low Expected outcomes reported low Davidson 1991 ? Stratified by LDL chol., method unclear ? Not described ? Personnel blinded, but groups received different number of packets ? Not stated low 5% attrition, analysis performed low Expected outcomes reported high Pattern of baseline dietary fibre varies with intervention Davy 2002 ? Method not stated ? Not described high Unclear, but obvious differences in foods ? Not stated low 11% attrition low Expected outcomes reported low 1990 High Sequential randomisation high Not detailed, unlikely with randomisation method high Not blinded ? Not stated ? 16% attrition, but unclear distribution low Expected outcomes reported low Gerhardt 1998 ? Method not stated ? Not described low Double blind ? Not stated low 10% attrition low Expected outcomes reported low Ibrugger 2013 (2 strata) low Computer generated sequence ? Not described low Double blind Low blinded low 19% attrition low Expected outcomes reported low Johnston 1998 ? Stratified by gender and LDL-C. Method not stated ? Not described high Unclear, but obvious differences in foods ? Not stated low 8% attrition low Expected outcomes reported low
Karmally 2005 ? Block randomisation, method unclear ? Not described high Unclear, but obvious differences in foods ? Not stated low 4% attrition low Expected outcomes reported low Kashtan 1992 ? Method not stated ? Not described low Double blind ? Not stated low 11% attrition low Expected outcomes reported low Keogh 2003 ? Method not stated ? Not described low Participants blinded ? Not stated low no attrition low Expected outcomes reported low Kerckhoffs 2003 ? Stratified by gender and age, method unclear ? Not described high Not blinded high Not blinded low 6% attrition low Expected outcomes reported low Kestin 1990 ? Method not stated although design grid ? Not described low Double blind ? Not stated low 14% attrition low Expected outcomes reported low Leadbetter 1991 ? Latin square ? Not described high Not blinded ? Not stated low 5% withdrew, but were replaced low Expected outcomes reported low Lepre 1992 ? Method not stated ? Not described low Double blind ? Not stated low 19% attrition low Expected outcomes reported low Li 2003 ? Method not stated ? Not described high Not blinded ? Not stated low No attrition low Expected outcomes reported low Lupton 1994 ? Method not stated ? Not described high Not stated, but one stratum involved capsule so unlikely ? Not stated low No attrition low Expected outcomes reported low Ma 2013 low Used a random number generator low Technicians and statisticians were blind unclear Not described but due to nature of intervention, unlikely low Technicians and statisticians were blind low Low attrition (5%) low Expected outcomes reported low
Maki 2003 ? Method not stated ? Not described low Double blind ? Not stated high 38% attrition, per protocol analysis low Expected outcomes reported low Maki 2010 ? Method not stated ? Not described high Not blinded ? Not stated high 29% attrition per protocol analysis low Expected outcomes reported low McGeoch 2013 low Performed by independent statistician ? Not described high Not blinded ? Not stated low No attrition low Expected outcomes reported low McIntosh 1991 ? Method not stated ? Not described high Unclear, likely detectable differences in food ? Not described low No attrition low Expected outcomes reported low Momenizadeh 2014 low Used a random number generator ? Not described ? Not described ? Not described low Low attrition (6%) low Expected outcomes reported low Newman 1989 ? Method not stated ? Not described low Participants blinded ? Not stated low No attrition low Expected outcomes reported low Noakes 1996 (2 strata) ? Method not stated ? Not described high Unclear, but obvious differences in foods ? Not stated low No attrition low Expected outcomes reported low Onning 1999 ? Method not stated ? Not described low Participants blinded ? Not stated high 22% attrition low Expected outcomes reported low Pick 1996 ? Method not stated ? Not described high Not blinded ? Not stated low No attrition low Expected outcomes reported low Poulter 1994 ? Method not stated high Participants randomised to day of attendance high Not blinded ? Not stated low 8% attrition low Expected outcomes reported high Systematic differences between control and intervention periods Robitaille 2005 ? Method not stated ? Not described high Not blinded ? Not stated low No attrition low Expected outcomes reported ? Intervention but not control
group prepared muffins. Rondanelli 2011 low Randomly permutated block randomisation list low Identical packaging low Double blind ? Not stated low No attrition low Expected outcomes reported low Saltzman 2001 ? Stratified by gender and age (and BMI in younger subjects), method unclear ? Not described high Unclear, but obvious differences in foods ? Not stated low No attrition low Expected outcomes reported, but not results of analysis low Swain 1990 ? Method not stated ? Not described high Participants blinded, but 90% correctly guessed intervention ? Not stated low 17% attrition low Expected outcomes reported low Sundberg 2008 ? Method not stated low Random allocation low Double low Blinded low 8% attrition low Expected outcomes reported low Theuwissen 2007 ? Method not stated ? Not described low Double blind ? Not stated low 2% attrition low Expected outcomes reported low Thongoun 2013 ? Method not stated ? Not described ? Not stated ? Not stated low 0% attrition low Expected outcomes reported low Torronen 1992 ? Method not stated ? Not described low Double blind ? Not stated low 7% attrition low Expected outcomes reported low Uusitupa 1992 ? Method not stated ? Not described low Double blind ? Not stated low 12% attrition low Expected outcomes reported high Uneven withdrawals created gender imbalance between groups Van Horn 1988 ? Stratified by gender and total chol., ? Not described high Not blinded ? Not stated low 8% attrition low Expected outcomes reported low
method unclear Van Horn 1991 ? Stratified by gender and total chol., method unclear ? Not described high Not blinded ? Not stated high 28% attrition low Expected outcomes reported low Vorster 1986 ? Method not stated ? Not described low Participants blinded ? Not stated low No attrition low Expected outcomes reported low 1992 ? Method not stated ? Not described ? Not stated ? Not stated low 4% attrition low Expected outcomes reported low Wolever 2010 low Computer generated low Sequentially numbered opaque envelopes low Double blind low Blinded low 6% attrition, analysis performed low Expected outcomes reported low Zhang 2012 ? Method not stated ? Not described high Not blinded low Statistician blinded low 9% attrition low Expected outcomes reported low ?, indicates unclear risk of bias Appendix 6 – GRADE summary of findings table for β-glucan Question: What is the food-health relationship between pure β-glucan and blood cholesterol concentration? Quality assessment of body of evidence Participants Effect estimate Quality (degree of certainty in relationship) Number of studies Design Risk of bias Inconsistency Indirectness Imprecision Considerations Mean difference (95% CI) Change in total cholesterol 0 Not applicable Not applicable Not applicable Not applicable 0 0 0 Change in LDL cholesterol 0 Not applicable Not applicable Not applicable Not applicable 0 0 0
Appendix 8 – GRADE summary of findings table for barley* Question: What is the food-health relationship between barley and blood cholesterol concentration? Quality assessment of body of evidence Participants Effect estimate Quality (degree of certainty in relationship) Number of studies Design Risk of bias Inconsistency Indirectness Imprecision Considerations Mean difference (95% CI) Change in total cholesterol 7 RCTs Low1 None None Serious# None 118 33 34 -0.32 [-0.42, Moderate Change in total cholesterol – baseline total cholesterol <5.5 mmol/L 2 RCTs Low1 None None Serious# None 10 7 7 -0.54 [-0.76, Moderate Change in total cholesterol – baseline total cholesterol ≥5.5 mmol/L 5 RCTs Low1 None None Serious# None 108 26 27 -0.27 [-0.36, Moderate Change in LDL cholesterol 7 RCTs Low1 None None Serious# None 118 33 34 -0.25 [-0.32, Moderate Change in LDL cholesterol – baseline total cholesterol <5.5 mmol/L 2 RCTs Low1 None None Serious# None 10 7 7 -0.30 [-0.39, Moderate Change in LDL cholesterol – baseline total cholesterol ≥5.5 mmol/L 5 RCTs Low1 None None Serious# None 108 26 27 -0.22 [-0.32, Moderate No change in HDL cholesterol 7 RCTs Low1 None None Serious None 118 33 34 -0.03 [-0.06, 0.00] Moderate