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

Kellogg´s

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Other: control wheat bran extract; Other: wheat bran extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01073969

PRV-08011

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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65 participants in 3 patient groups, including a placebo group

Control cereal

Placebo Comparator group

Description:

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

Treatment:

Other: control wheat bran extract

low dose

Active Comparator group

Description:

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

Treatment:

Other: wheat bran extract

High dose

Active Comparator group

Description:

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

Treatment:

Other: wheat bran extract