Clinical trial NCT01073969: Study to Determine the Digestive and Physiological Effects of an Extract From Bran in Healthy Men and Women
Official title: A Double-blind, Randomized, Controlled Crossover Trial to Assess the Digestive and Physiological Effects of a Wheat Bran Extract in Healthy Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: prebiotic study
modulating colonic bacteria
Lead sponsor: Kellogg Company
Sponsor class: INDUSTRY
Collaborators: name: Provident Clinical Research
name: Tufts University
name: University of Toronto
name: University of Reading
name: University of Saskatchewan
First posted: 2010-02-23
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Baseline to end of each treatment (week 0 to week 3 of each treatment)
Secondary outcomes:
measure: Other fecal bacterial counts
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: laxation
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: fecal pH
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: fecal moisture
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: stool consistency
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: blood glucose
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: Blood insulin
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: plasma lipid profiles
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: serum free fatty acids
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: fecal short chain fatty acids
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: fecal ammonia
timeFrame: baseline to end of each treament (week 0 to week 3 of each treatment)
measure: urinary para-cresol
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: urinary phenol (total)
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: urinary isoprostanes
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: oxidized low density lipoprotein (TBARS, conjugated dienes)
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: Urinary F2alpha-isoprostanes
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: Plasma antioxidant capacity (ORAC, FRAP)
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: serum amyloid A
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: hs-CRP
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: IL-6
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: TNF-alpha
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: gastrointestinal symptom survey
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: stool consistency (Bristol stool scale)
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
measure: Quality of Life questionaire (Quality Metrics SF-36)
timeFrame: baseline to end of each treatment (week 0 to week 3 of each treatment)
Other outcomes:
Locations:
city: Glen Ellyn
country: United States
facility: Provident CRC
state: Illinois
Study officials:
affiliation: Provident Clinical Research and Consulting, Inc
name: Kevin Maki, PhD
role: STUDY_DIRECTOR
References: