Study to Determine the Digestive and Physiological Effects of an Extract From Bran in Healthy Men and Women

Study Overview
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Brief Summary
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The primary objective of this trial is to determine whether two doses of an extract from bran demonstrate a prebiotic effect on colonic bacteria (by modulating selected fecal microbial populations, particularly bifidobacteria). The secondary objective is to measure the potential beneficial effects of consuming an extract from bran on the following physiological parameters: laxation, fecal pH, fecal moisture and stool consistency, blood glucose and insulin concentrations, plasma lipid profiles and serum free fatty acids, colonic bacterial short chain fatty acid production, ammonia metabolism and protein degradation, and biomarkers of oxidative stress and inflammation.

Official Title
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A Double-blind, Randomized, Controlled Crossover Trial to Assess the Digestive and Physiological Effects of a Wheat Bran Extract in Healthy Men and Women

Conditions
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Healthy

Intervention / Treatment
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* Other: wheat bran extract
* Other: control wheat bran extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18-75 years of age Body mass index ≥18.5 and <35.0 kg/m2 Fasting LDL-C level ≥100 mg/dL and <200 mg/dL Otherwise judged to be in good health, willing to maintain habitual food and beverage intake and physical activity patterns throughout the trial Exclusion Criteria: Significant gastrointestinal condition Use of pre/probiotic foods or supplements Use of antibiotics Pregnancy Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications Poorly controlled hypertension Cancer treated within prior 2 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control cereal<br>grain-based ready to eat cereal that does not contain active wheat bran extract | Other: control wheat bran extract<br>* Comparison of control cereal (containing no added wheat bran extract) to two test cereals containing different amounts of added wheat bran extract<br>* Other names: prebiotic oligosccharides;|
| Active Comparator: low dose<br>grain-based ready to eat cereal containing a low dose of wheat bran extract | Other: wheat bran extract<br>* Comparison of control cereal (containing no added wheat bran extract)to two test cereals containing different amounts of added wheat bran extract<br>* Other names: prebiotic oligosccharides;|
| Active Comparator: High dose<br>grain-based ready to eat cereal that contains a high dose of wheat bran extract | Other: wheat bran extract<br>* Comparison of control cereal (containing no added wheat bran extract)to two test cereals containing different amounts of added wheat bran extract<br>* Other names: prebiotic oligosccharides;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome variable will be the difference between treatments in bifidobacteria counts per g of feces, expressed as log10 cells per g feces (dry weight) |  | Baseline to end of each treatment (week 0 to week 3 of each treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other fecal bacterial counts |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| laxation |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| fecal pH |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| fecal moisture |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| stool consistency |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| blood glucose |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| Blood insulin |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| plasma lipid profiles |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| serum free fatty acids |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| fecal short chain fatty acids |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| fecal ammonia |  | baseline to end of each treament (week 0 to week 3 of each treatment) | 
| urinary para-cresol |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| urinary phenol (total) |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| urinary isoprostanes |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| oxidized low density lipoprotein (TBARS, conjugated dienes) |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| Urinary F2alpha-isoprostanes |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| Plasma antioxidant capacity (ORAC, FRAP) |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| serum amyloid A |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| hs-CRP |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| IL-6 |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| TNF-alpha |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| gastrointestinal symptom survey |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| stool consistency (Bristol stool scale) |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 
| Quality of Life questionaire (Quality Metrics SF-36) |  | baseline to end of each treatment (week 0 to week 3 of each treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prebiotic study, modulating colonic bacteria