Skip to content

Effect of low dose galacto-oligosaccharides (GOS) on faecal gut microbiota in adult women

Effect of low dose galacto-oligosaccharides (GOS) on faecal gut microbiota in adult women - Denali study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53648
Enrollment
88
Registered
2023-03-02
Start date
2023-03-22
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

n.v.t. gut bacteria microbiota

Interventions

Subjects receive 1 sachet of GOS (1.3 or 2 grams) per day. They have to dissolve this in a product of their choice (water, yogurt, milk, tea, coffee, custard) at breakfast. Subjects are instructed t

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Apparently healthy women (based on screening questionnaire), living in the surrounding of Wageningen (+50 km ) - Aged between 40 - 70 year - Body Mass Index (BMI) between 18,5 - 30 kg/m2

Exclusion criteria

Exclusion criteria: - Having a gastro-intestinal disease, such as celiac disease, Crohn*s disease, Ulcerative colitis, or diagnosed irritable bowel disease; - Having a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy; - Diagnosed with diabetes mellitus; Use of medication that may influence the study results, such as laxatives, lactase preparations, metformin, antibiotics, proton pomp inhibitors, antipsychotics, NSAID*s (judged by our research physician); - Self-perceived or diagnosed constipation; - Having a food allergy to cow*s milk or being lactose intolerant; - Reported slimming, medically prescribed or other diets - Reported weight loss or weight gain of >5kg in the month prior to screening - Use of pre-, pro- , syn- and/or postbiotics (should be stopped at least 4 weeks before the start of the study), or other supplements that can influence the study results (to be determined by the medical investigator); - History of side effects with the use of prebiotic supplements - Use of antibiotic treatment less than 3 months before start of the study - Pregnant or lactating (or having the wish to become pregnant during the study period, self-reported); - Not able to comply with study procedures; - Abuse of drugs (should be stopped at least 4 weeks before the study); - Alcohol intake >=7 glasses of alcoholic beverages per week, on average - Participation in another clinical trial at the same time; - Being an employee of the Food, Health & Consumer Research group of Wageningen Food & Biobased Research or employee of FrieslandCampina R&D.

Design outcomes

Primary

MeasureTime frame
The main study parameter is the absolute abundance of faecal Bifidobacterium.

Secondary

MeasureTime frame
The secondary study parameters are faecal microbiota composition. Tertiary Objectives are gastrointestinal (GI) comfort, sleep quality (Athens Insomnia scale), well-being and stress (DASS-21).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)