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Completed

NCT Number: NCT01814540

Bovine Milk Oligosaccharide Study

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bovine Milk Oligosaccharide

Dietary Supplement

The BMO powder will be isolated from whey streams by Hilmar Ingredients (Hilmar, California 95324). Hilmar Ingredients employs the same membrane filtration, and centrifugation processes used to purify whey protein in their commercial practice to extract and purify BMO from whey permeate. Furthermore, the same sterilization processes used on the equipment to purify whey products will be used to purify BMO. This method uses a novel high-throughput food-grade isolation protocol that leads to purification of specific BMOs with bifidogenic activity as prebiotic oligosaccharides that mimic the activities observed for Human Milk Oligosaccharides (HMO). This strategy of developing methods for their large scale fractionation allows us to obtain a final product that mimics the naturally beneficial oligosaccharides present in human milk.

Placebo Glucose Polymer

Dietary Supplement

Primary outcomes

  1. 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

  1. Urinary Metabolites

    Time frame: Days 0, 4, 11

    First morning urine samples will be analyzed by nuclear magnetic resonance spectroscopy.

  2. Plasma Lipid Profile

    Time frame: 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.

  3. Plasma Glucose

    Time frame: Day 0 and Day 11

    Fasting plasma glucose will be measured by enzyme analysis by UC Davis Pathology Lab.

  4. Dietary Macronutrient Intake

    Time frame: 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.

  5. Gut Tolerability

    Time frame: 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.

  6. Stool Consistency

    Time frame: 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.

  7. Fecal BMO

    Time frame: Days 0, 4 and 11

    Measurement of BMOs in feces

  8. Fecal Metatranscriptome

    Time frame: Days 0 and 11

    Measurement of fecal metatranscriptome

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Dairy Research Institute

Registry information

Official study title

Pilot Study: Tolerability of Feeding Different Doses of Bovine Milk Oligosaccharides for Modifying Gastrointestinal Function in Healthy Individuals

Acronym: BMO

Important dates

Study start
2012
Primary completion
2012
Study completion
2021
First posted
Mar 20, 2013
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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