Microbial ColonizationDenaliNCT05762965
Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women
A study testing GOS 1 and GOS 2 in people with Microbial Colonization, run by Wageningen University and Research at 1 site in Netherlands.
Trial summary
Within the Denali study the effect of 3 weeks intervention with GOS on the abundance of Bifidobacterium in faecal samples will be investigated. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- GOS 1 and GOS 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 May 2023to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy women
- Aged between 40 - 70 year
- Body Mass Index (BMI) between 18.5 - 30 kg/m2
Who cannot join
- Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, Ulcerative colitis, or diagnosed irritable bowel syndrome;
- 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 and diagnosed constipation;
- Having a food allergy to cow's milk or being lactose intolerant;
Show all 17Show fewer
- Self-reported slimming, medically prescribed or other diets
- Reported weight loss or weight gain of >5kg in the month prior to screening
- Use of (foods with) 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;
- Use 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.
Trial locations and contacts
1 site in 1 country.
About this study
Within the Denali study the effect of 3 weeks intervention with GOS on the abundance of Bifidobacterium in faecal samples will be investigated.
Read the detailed description
This randomized, parallel, double-blinded intervention study of 6 weeks will include 88 females, who will consume GOS for three consecutive weeks. Faecal samples will be collected at several time points to measure microbiota composition.
- Conditions
- Microbial Colonization
- Being tested
- GOS 1, GOS 2
- Keywords
- galacto-oligosaccharides, prebiotics, microbiota
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOS 1Dietary supplement
Also called galacto oligosaccharide
1 sachet each morning
GOS 2Dietary supplement
Also called galacto oligosaccharide
1 sachet each morning
| Study group | Role | What they receive |
|---|---|---|
| GOS 1 | Experimental | Galacto-oligosaccharide Receives: Dietary Supplement: GOS 1 |
| GOS 2 | Experimental | Galacto-oligosaccharide Receives: Dietary Supplement: GOS 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
faecal abundance of Bifidobacterium
faecal abundance of Bifidobacterium.
Measured: At week -3 (start control)
faecal abundance of Bifidobacterium
faecal abundance of Bifidobacterium.
Measured: At week 0 (end control)
faecal abundance of Bifidobacterium
faecal abundance of Bifidobacterium.
Measured: At week 3 (end intervention)
Secondary outcomes (3)
Faecal microbiota composition
Gene-based microbiota profiling of faecal samples
Measured: At week -3 (start control)
Faecal microbiota composition
Gene-based microbiota profiling of faecal samples
Measured: At week 0 (end control)
Faecal microbiota composition
Gene-based microbiota profiling of faecal samples
Measured: At week 3 (end intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start12 May 2023
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study applies a randomized, parallel, double-blind design of 6 weeks
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
- Investigators
- Maartje van den Belt, Msc, Principal investigator, Wageningen Food and Biobased Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762965
- Sponsor's protocol ID
- 6239229900
- Acronym
- Denali
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Looijesteijn E, Schoemaker MH, van den Belt M, Hester ER, Kortman GAM, Viskaal-van Dongen M, Nauta A. A double-blind intervention trial in healthy women demonstrates the beneficial impact on Bifidobacterium with low dosages of prebiotic galacto-oligosaccharides. Front Nutr. 2024 Aug 19;11:1440319. doi: 10.3389/fnut.2024.1440319. eCollection 2024.
PubMed 39224188
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women
- ClinicalTrials.gov ID
- NCT05762965
- Acronym / sponsor ID
- Denali / 6239229900
- Conditions
- Microbial Colonization
- Keywords
- galacto-oligosaccharides, prebiotics, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- 12 May 2023 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Within the Denali study the effect of 3 weeks intervention with GOS on the abundance of Bifidobacterium in faecal samples will be investigated.
Detailed description
This randomized, parallel, double-blinded intervention study of 6 weeks will include 88 females, who will consume GOS for three consecutive weeks. Faecal samples will be collected at several time points to measure microbiota composition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study applies a randomized, parallel, double-blind design of 6 weeks
| Arm | Type | Receives |
|---|---|---|
| GOS 1 | Experimental | Dietary Supplement: GOS 1Galacto-oligosaccharide |
| GOS 2 | Experimental | Dietary Supplement: GOS 2Galacto-oligosaccharide |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Apparently healthy women
- Aged between 40 - 70 year
- Body Mass Index (BMI) between 18.5 - 30 kg/m2
Key exclusion criteria (17 listed)
- Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, Ulcerative colitis, or diagnosed irritable bowel syndrome;
- 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 and diagnosed constipation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GOS 1Also: galacto oligosaccharide1 sachet each morning | Dietary supplement | GOS 1 |
| GOS 2Also: galacto oligosaccharide1 sachet each morning | Dietary supplement | GOS 2 |
Primary outcome
faecal abundance of Bifidobacterium
Time frame: At week -3 (start control)
faecal abundance of Bifidobacterium.
faecal abundance of Bifidobacterium
Time frame: At week 0 (end control)
faecal abundance of Bifidobacterium.
faecal abundance of Bifidobacterium
Time frame: At week 3 (end intervention)
faecal abundance of Bifidobacterium.
3 secondary outcomes
Faecal microbiota composition
Time frame: At week -3 (start control)
Faecal microbiota composition
Time frame: At week 0 (end control)
Faecal microbiota composition
Time frame: At week 3 (end intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 39224188Looijesteijn E, Schoemaker MH, van den Belt M, Hester ER, Kortman GAM, Viskaal-van Dongen M, Nauta A. A double-blind intervention trial in healthy women demonstrates the beneficial impact on Bifidobacterium with low dosages of prebiotic galacto-oligosaccharides. Front Nutr. 2024 Aug 19;11:1440319. doi: 10.3389/fnut.2024.1440319. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maartje van den Belt, Msc principal investigator
Wageningen Food and Biobased Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GOS 1 and GOS 2 in people with Microbial Colonization, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
faecal abundance of Bifidobacterium (time frame: At week -3 (start control)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05762965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.