Pilot Study: Tolerability of Feeding Different Doses of Bovine Milk Oligosaccharides for Modifying Gastrointestinal Function in Healthy Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Gut microbiota
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Placebo Control, 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.
Intervention: Placebo Glucose Polymer (Dietary Supplement)
Treatment 2: Low-Dose BMO
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.
Intervention: Bovine Milk Oligosaccharide (Dietary Supplement)
Treatment 3: High-Dose BMO
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.
Intervention: Bovine Milk Oligosaccharide (Dietary Supplement)
Outcomes
Primary Outcomes
Gut microbiota
Time Frame: 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 Outcomes
- Urinary Metabolites(Days 0, 4, 11)
- Stool Consistency(Minus Day 7 and Days 0-10)
- Fecal BMO(Days 0, 4 and 11)
- Fecal Metatranscriptome(Days 0 and 11)
- Plasma Lipid Profile(Day 0 and Day 11)
- Plasma Glucose(Day 0 and Day 11)
- Dietary Macronutrient Intake(Day 0)
- Gut Tolerability(Days Minus 7 and Days 0-10)