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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Other: control wheat bran extract; Other: wheat bran extract

• Registration Number: NCT01073969
• Lead Sponsor: Kellogg Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-07
• Study Completion: 2009-08
• Status Verified: 2010-02
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-22
• Last Update Submitted: 2010-02-22
• Study First Posted: 2010-02-23
• Last Update Posted: 2010-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control cereal	control wheat bran extract	grain-based ready to eat cereal that does not contain active wheat bran extract
low dose	wheat bran extract	grain-based ready to eat cereal containing a low dose of wheat bran extract
High dose	wheat bran extract	grain-based ready to eat cereal that contains a high dose of wheat bran extract

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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)
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)
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)

Trial Locations

Locations (1)

Provident CRC; 🇺🇸 Glen Ellyn, Illinois, United States