Bovine Milk Oligosaccharide Study
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 3/23/2019 |
| Start Date: | August 2012 |
| End Date: | November 2012 |
Pilot Study: Tolerability of Feeding Different Doses of Bovine Milk Oligosaccharides for Modifying Gastrointestinal Function in Healthy Individuals
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.
the complex indigestible sugars from dairy products called bovine milk oligosaccharides (BMO)
to enrich intestinal microflora toward beneficial populations.
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.
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.
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
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