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

NCT01073969 | Completed Phase 4

• 1 other identifier: PRV-08011
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

prebiotic study; modulating colonic bacteria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• 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)

Study Arms (3)

Control cereal

PLACEBO COMPARATOR

grain-based ready to eat cereal that does not contain active wheat bran extract

Other: control wheat bran extract

low dose

ACTIVE COMPARATOR

grain-based ready to eat cereal containing a low dose of wheat bran extract

Other: wheat bran extract

High dose

ACTIVE COMPARATOR

grain-based ready to eat cereal that contains a high dose of wheat bran extract

Other: wheat bran extract

Interventions

wheat bran extract OTHER

Comparison of control cereal (containing no added wheat bran extract)to two test cereals containing different amounts of added wheat bran extract

Also known as: wheat bran oligosccharides, prebiotic oligosccharides

High dose; low dose

control wheat bran extract OTHER

Comparison of control cereal (containing no added wheat bran extract) to two test cereals containing different amounts of added wheat bran extract

Also known as: wheat bran oligosccharides, prebiotic oligosccharides

Control cereal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kellogg Company: lead
• Provident Clinical Research: collaborator
• Tufts University: collaborator
• University of Toronto: collaborator
• University of Reading: collaborator
• University of Saskatchewan: collaborator

Study Sites (1)

Provident CRC

Glen Ellyn, Illinois, 60137, United States

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kevin Maki, PhD

  Provident Clinical Research and Consulting, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 23, 2010
• Study Start: March 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 23, 2010

Record last verified: 2010-02

Locations

US (1)