GOS and Microbial Fermentation in Aging (NCT03077529) | Clinical Trial Compass
CompletedNot Applicable
GOS and Microbial Fermentation in Aging
Netherlands44 participantsStarted 2017-03-20
Plain-language 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. 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.
Who can participate
Age range
25 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Creatinin value of 60-115 μmol/L for men, 50-100 μmol/L for women.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Microbial composition
Timeframe: Change from baseline to four weeks supplementation, of each intervention period
2
Microbial activity
Timeframe: Change from baseline to four weeks supplementation, of each intervention period
. Alanine transaminase (ALAT) value of \<45 U/L for men, 34 U/L for women.
Exclusion criteria
. 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.
. Use of laxatives within 14 days prior to the study.
. Institutionalized (e.g. hospital or nursing home).