Healthy Young AdultsNCT03077529
GOS and Microbial Fermentation in Aging
A study testing Galacto-oligosacchride and Maltodextrin in people with Healthy Young Adults and Prefrail Elderly, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The population is aging worldwide, concomitant frailty is increased in older age groups. Frailty has a strong impact on outcomes of multi-morbidity and daily living, thereby negatively influencing quality of life and health care costs. Prevention or delay of onset of frailty associated with aging is needed. Read more about this study
- Who is it for?
- Ages 25 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults, Prefrail Elderly
- What is being tested?
- Galacto-oligosacchride and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Mar 2017to 6 Sep 2018
- 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 25 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Based on medical history no gastrointestinal complaints can be defined.
- Age 25 - 50 years and classified as 'robust' by the Fried frailty criteria, or age 70 - 85 years and classified as 'prefrail' by the Fried frailty criteria.
- Body Mass Index (BMI) ≥ 20 and < 30 kg/m2.
- Weight-stable for at least 90 days prior to participation (no change in bodyweight, i.e. < 3kg).
- Hemoglobin value of 8.2-11.0 mmol/L for men, 7.3-9.7 mmol/L for women.
- C-reactive protein (CRP) value of <10 mg/L.
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- Creatinin value of 60-115 μmol/L for men, 50-100 μmol/L for women.
- Alanine transaminase (ALAT) value of <45 U/L for men, 34 U/L for women.
- Gamma-glutamyl transpeptidase (GGT) value of <55 U/L for men, <38 U/L for women.
- Will be informed in case of any unexpected finding.
Who cannot join
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- Self-admitted human immunodeficiency virus-positive state.
- Disease with a life expectancy shorter than 5 years.
- Abdominal surgery interfering with gastrointestinal function, upon judgment of the medical doctor, who will decide on in- or exclusion based on the surgery applied.
- Use of antibiotics products within 90 days prior to the study.
- Use of other medication will be reviewed by a medical doctor, who will decide on in- or exclusion based on the drug(s) used.
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- Use of laxatives within 14 days prior to the study.
- Institutionalized (e.g. hospital or nursing home).
- Pregnancy or lactation.
- Plan to lose weight or follow a specific diet within the study period.
- Alcohol intake >14 units/week.
- Drug use.
- Blood donation within 30 days prior to the study.
- Administration of probiotic or prebiotic supplements, investigational drugs or participation in any scientific intervention study, which may interfere with this study (to be decided by the principle investigator), in the 14 days prior to the study.
- History of side effects towards intake of prebiotic supplements.
- Self-admitted lactose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Galacto-oligosaccharides on Microbial Fermentation Capacity and Markers of Frailty in Healthy Adults and Elderly
The population is aging worldwide, concomitant frailty is increased in older age groups. Frailty has a strong impact on outcomes of multi-morbidity and daily living, thereby negatively influencing quality of life and health care costs. Prevention or delay of onset of frailty associated with aging is needed. Dietary intake of galacto-oligosaccharides (GOS) may have beneficial effects on microbiota composition and health outcome parameters. As microbiota composition and function may be altered in elderly compared to younger adults, it will investigated whether the effects of GOS on selected parameters of microbiota and gut health differ between elderly versus younger adults. The primary objective of this study is to compare the effects of four weeks GOS supplementation on intestinal microbiota composition and activity in elderly versus younger adults. Further, this study has four secondary objectives. The study conforms to a randomized double-blind placebo-controlled cross-over design per age-group. Study populations are human volunteers (male and female), healthy young adults of 25-50 years and prefail older adults of 70-85 years old, BMI 20-30 kg/m2. One intervention period subjects will receive 7.2 grams of Vivinal® GOS Powder three times daily for four weeks. The other intervention period subjects will receive isocaloric placebo supplements (5.7 grams maltodextrin) three times daily for four weeks. At the start and end of each intervention period, several measurements will take place. There will be a washout period of four to five weeks between intervention periods. The main study parameter is the change in microbial composition and activity induced by GOS intervention, in younger adults and elderly.
- Conditions
- Healthy Young Adults, Prefrail Elderly
- Being tested
- Galacto-oligosacchride, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galacto-oligosacchrideDietary supplement
During this period subjects will receive 5.65 grams of Vivinal GOS supplements three times daily for four weeks
MaltodextrinDietary supplement
During this period subjects will receive 7.24 grams of maltodextrin supplements three times daily for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Galacto-oligosaccharide | Experimental | During this period subjects will receive 5.65 grams of Vivinal GOS supplements three times daily for four weeks Receives: Dietary Supplement: Galacto-oligosacchride |
| Maltodextrin | Placebo comparator | During this period subjects will receive 7.24 grams of maltodextrin supplements three times daily for four weeks Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial composition
Microbiota composition and functional capacity as measured by HiSeq sequencing of fecal 16S rRNA genes.
Measured: Change from baseline to four weeks supplementation, of each intervention period
Microbial activity
Microbial activity as measured by metabolites, such as organic acids analysis in feces and plasma.
Measured: Change from baseline to four weeks supplementation, of each intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start20 Mar 2017
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
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 Healthy Young AdultsStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University
- Responsible party
- Sponsor
- Investigators
- A.A.M. Masclee, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077529
- Sponsor's protocol ID
- 163046
- Status last verified
- Apr 2018
- First submitted
- 3 Mar 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilms E, An R, Smolinska A, Stevens Y, Weseler AR, Elizalde M, Drittij MJ, Ioannou A, van Schooten FJ, Smidt H, Masclee AAM, Zoetendal EG, Jonkers DMAE. Galacto-oligosaccharides supplementation in prefrail older and healthy adults increased faecal bifidobacteria, but did not impact immune function and oxidative stress. Clin Nutr. 2021 May;40(5):3019-3031. doi: 10.1016/j.clnu.2020.12.034. Epub 2021 Jan 12.
PubMed 33509667
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Galacto-oligosaccharides on Microbial Fermentation Capacity and Markers of Frailty in Healthy Adults and Elderly
- ClinicalTrials.gov ID
- NCT03077529
- Acronym / sponsor ID
- 163046
- Conditions
- Healthy Young Adults, Prefrail Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Wageningen University
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 13 Mar 2017 (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.
The population is aging worldwide, concomitant frailty is increased in older age groups. Frailty has a strong impact on outcomes of multi-morbidity and daily living, thereby negatively influencing quality of life and health care costs. Prevention or delay of onset of frailty associated with aging is needed. Dietary intake of galacto-oligosaccharides (GOS) may have beneficial effects on microbiota composition and health outcome parameters. As microbiota composition and function may be altered in elderly compared to younger adults, it will investigated whether the effects of GOS on selected parameters of microbiota and gut health differ between elderly versus younger adults. The primary objective of this study is to compare the effects of four weeks GOS supplementation on intestinal microbiota composition and activity in elderly versus younger adults. Further, this study has four secondary objectives. The study conforms to a randomized double-blind placebo-controlled cross-over design per age-group. Study populations are human volunteers (male and female), healthy young adults of 25-50 years and prefail older adults of 70-85 years old, BMI 20-30 kg/m2. One intervention period subjects will receive 7.2 grams of Vivinal® GOS Powder three times daily for four weeks. The other intervention period subjects will receive isocaloric placebo supplements (5.7 grams maltodextrin) three times daily for four weeks. At the start and end of each intervention period, several measurements will take place. There will be a washout period of four to five weeks between intervention periods. The main study parameter is the change in microbial composition and activity induced by GOS intervention, in younger adults and elderly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galacto-oligosaccharide | Experimental | Dietary Supplement: Galacto-oligosacchrideDuring this period subjects will receive 5.65 grams of Vivinal GOS supplements three times daily for four weeks |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinDuring this period subjects will receive 7.24 grams of maltodextrin supplements three times daily for four weeks |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Based on medical history no gastrointestinal complaints can be defined.
- Age 25 - 50 years and classified as 'robust' by the Fried frailty criteria, or age 70 - 85 years and classified as 'prefrail' by the Fried frailty criteria.
- Body Mass Index (BMI) ≥ 20 and < 30 kg/m2.
- Weight-stable for at least 90 days prior to participation (no change in bodyweight, i.e. < 3kg).
- Hemoglobin value of 8.2-11.0 mmol/L for men, 7.3-9.7 mmol/L for women.
Key exclusion criteria (16 listed)
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- Self-admitted human immunodeficiency virus-positive state.
- Disease with a life expectancy shorter than 5 years.
- Abdominal surgery interfering with gastrointestinal function, upon judgment of the medical doctor, who will decide on in- or exclusion based on the surgery applied.
- Use of antibiotics products within 90 days prior to the study.
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 |
|---|---|---|
| Galacto-oligosacchrideDuring this period subjects will receive 5.65 grams of Vivinal GOS supplements three times daily for four weeks | Dietary supplement | Galacto-oligosaccharide |
| MaltodextrinDuring this period subjects will receive 7.24 grams of maltodextrin supplements three times daily for four weeks | Dietary supplement | Maltodextrin |
Primary outcome
Microbial composition
Time frame: Change from baseline to four weeks supplementation, of each intervention period
Microbiota composition and functional capacity as measured by HiSeq sequencing of fecal 16S rRNA genes.
Microbial activity
Time frame: Change from baseline to four weeks supplementation, of each intervention period
Microbial activity as measured by metabolites, such as organic acids analysis in feces and plasma.
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 7 Sep 2018.
- Derived from this study: PubMed 33509667Wilms E, An R, Smolinska A, Stevens Y, Weseler AR, Elizalde M, Drittij MJ, Ioannou A, van Schooten FJ, Smidt H, Masclee AAM, Zoetendal EG, Jonkers DMAE. Galacto-oligosaccharides supplementation in prefrail older and healthy adults increased faecal bifidobacteria, but did not impact immune function and oxidative stress. Clin Nutr. 2021 May;40(5):3019-3031. doi: 10.1016/j.clnu.2020.12.034. Epub 2021 Jan 12.
- 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.
A.A.M. Masclee principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galacto-oligosacchride and Maltodextrin in people with Healthy Young Adults and Prefrail Elderly, run by Maastricht University Medical Center 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 10 inclusion and 16 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 7 Sep 2018. 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. Some participants in this study may receive a placebo. 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?
Microbial composition (time frame: Change from baseline to four weeks supplementation, of each intervention period). The study lists 2 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 NCT03077529, 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 7 Sep 2018.