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

Kellogg Company65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: Baseline to end of each treatment (week 0 to week 3 of each treatment)