Bovine Milk Oligosaccharide Study (BMO)

University of California (UC) Davis

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Placebo Glucose Polymer; Dietary Supplement: Bovine Milk Oligosaccharide

Study type: Interventional

Funder types: Other

Identifiers

NCT01814540

264294

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 3 patient groups, including a placebo group

Placebo Control, Glucose polymer

Placebo Comparator group

Description:

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:

Dietary Supplement: Placebo Glucose Polymer

Treatment 2: Low-Dose BMO

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Bovine Milk Oligosaccharide

Treatment 3: High-Dose BMO

Experimental group

Description:

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:

Dietary Supplement: Bovine Milk Oligosaccharide