Bovine Milk Oligosaccharide Study

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo Glucose Polymer; Dietary Supplement: Bovine Milk Oligosaccharide

• Registration Number: NCT01814540
• Lead Sponsor: University of California, Davis

Brief Summary

The purpose of this study is to elucidate tolerability and effectiveness in consumption of the complex indigestible sugars from dairy products called bovine milk oligosaccharides (BMO) to enrich intestinal microflora toward beneficial populations.

Detailed Description

This is a single-blind crossover study designed to determine if BMO at two different doses selectively enrich beneficial bacteria in the human gut and will be tolerated in healthy participants compared with a placebo control supplement. Each participant will consume two sachets of supplement for eleven days, separated by a two-week washout before starting the second and third arms. To determine the effect of dose, the placebo-control supplement will be administered in the first arm, followed by the low and high dose. Participants will collect stool and first morning urine and study personnel collected blood from each participant at baseline (day 0) and at the end (Day 11) of each study arm for all three arms.

Study Timeline

• Study Start: 2012-08-01
• Primary Completion: 2012-11-16
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-19
• Study First Posted: 2013-03-20
• Study Completion: 2021-01-22
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy men and women aged 18-40 years old
• BMI 18-25
• Born by vaginal birth (not C-section)
• Breastfed for a minimum of 2 months after birth

Exclusion Criteria

• Individuals who regularly consume high fiber cereals or fiber supplements
• Individuals who frequently consume yogurt (eligible if willing to refrain consumption during the study period)
• Individuals who are lactose intolerant and/or allergic to dairy or wheat
• Individuals who use tobacco products
• Individuals who are pregnant or lactating
• Individuals with a known presence of gastrointestinal/malabsorption disorders or autoimmune disease
• Individuals taking prescription or over-the-counter medications that include pre/probiotics, corticosteroids, anti-obesity agents, laxatives, and lipid- altering medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Control, Glucose polymer	Placebo Glucose Polymer	Treatment 1: Polycose Glucose Polymer Module powder (Abbott Nutrition, Abbott Park, Illinois 60064), fed as 25% of each individual's daily fiber intake based on calculated energy expenditure (14 grams of fiber for every 1000 kcal consumed) for eleven consecutive days.
Treatment 3: High-Dose BMO	Bovine Milk Oligosaccharide	Treatment 3: Bovine Milk Oligosaccharide (BMO) powder (Hilmar Ingredients, Hilmar, California 95324) Dosage: 35% of individual daily fiber intake, split into two daily servings Frequency: Two servings per day (for total of 25% dosage per day) Duration: 11 days, followed by a 2-week wash-out period Fiber intake was 35% of each individual's daily fiber intake based on calculated energy expenditure (14 grams of fiber for every 1000 kcal consumed) for eleven consecutive days.
Treatment 2: Low-Dose BMO	Bovine Milk Oligosaccharide	Treatment 2: Bovine Milk Oligosaccharide (BMO) powder (Hilmar Ingredients, Hilmar, California 95324) Dosage: 25% of individual daily fiber intake, split into two daily servings Frequency: Two servings per day (for total of 25% dosage per day) Duration: 11 days, followed by a 2-week wash-out period Fiber intake was 25% of each individual's daily fiber intake based on calculated energy expenditure (14 grams of fiber for every 1000 kcal consumed) for eleven consecutive days.

Primary Outcome Measures

Name	Time	Method
Gut microbiota	Change from baseline to day 11	Gut microbiota will be analyzed for 16s rRNA by next generation sequencing, terminal restriction fragment length polymorphism, and quantitative polymerase chain reaction.

Secondary Outcome Measures

Name	Time	Method
Urinary Metabolites	Days 0, 4, 11	First morning urine samples will be analyzed by nuclear magnetic resonance spectroscopy.
Stool Consistency	Minus Day 7 and Days 0-10	Participants will fill out the Bristol Stool Scale when they have bowel movements seven days before starting each study arm and daily during each study arm. The discretized visual analog scale 1-7 describes hardness to softness of stool.
Fecal BMO	Days 0, 4 and 11	Measurement of BMOs in feces
Fecal Metatranscriptome	Days 0 and 11	Measurement of fecal metatranscriptome
Plasma Lipid Profile	Day 0 and Day 11	Fasting plasma lipid profile (total triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol) will be analyzed by enzymatic analysis by UC Davis Pathology Lab.
Plasma Glucose	Day 0 and Day 11	Fasting plasma glucose will be measured by enzyme analysis by UC Davis Pathology Lab.
Dietary Macronutrient Intake	Day 0	Participants will fill out three-day diet records for two weekdays and one weekend before starting each dietary supplemental arm in order to determine if intake of BMO vs. placebo control influences habitual dietary intake.
Gut Tolerability	Days Minus 7 and Days 0-10	Participants will fill out a standardized gut tolerability questionnaire (Pedersen et al., 1997) rating their symptoms of gut and stomach discomfort on a 0-10 discretized visual analog scale daily seven days before starting each arm and on five different occasions on Days 0-10 during each study arm.

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Davis, California, United States