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GOS and Microbial Fermentation in Aging

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ClinicalTrials.gov Identifier: NCT03077529
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Wageningen University
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Young Adults Prefrail Elderly Dietary Supplement: Galacto-oligosacchride Dietary Supplement: Maltodextrin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Galacto-oligosaccharides on Microbial Fermentation Capacity and Markers of Frailty in Healthy Adults and Elderly
Actual Study Start Date : March 20, 2017
Actual Primary Completion Date : September 6, 2018
Actual Study Completion Date : September 6, 2018

Arm Intervention/treatment
Experimental: Galacto-oligosaccharide
During this period subjects will receive 5.65 grams of Vivinal GOS supplements three times daily for four weeks
Dietary Supplement: Galacto-oligosacchride
During this period subjects will receive 5.65 grams of Vivinal GOS supplements three times daily for four weeks

Placebo Comparator: Maltodextrin
During this period subjects will receive 7.24 grams of maltodextrin supplements three times daily for four weeks
Dietary Supplement: Maltodextrin
During this period subjects will receive 7.24 grams of maltodextrin supplements three times daily for four weeks




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Based on medical history no gastrointestinal complaints can be defined.
  2. 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.
  3. Body Mass Index (BMI) ≥ 20 and < 30 kg/m2.
  4. Weight-stable for at least 90 days prior to participation (no change in bodyweight, i.e. < 3kg).
  5. Hemoglobin value of 8.2-11.0 mmol/L for men, 7.3-9.7 mmol/L for women.
  6. C-reactive protein (CRP) value of <10 mg/L.
  7. Creatinin value of 60-115 μmol/L for men, 50-100 μmol/L for women.
  8. Alanine transaminase (ALAT) value of <45 U/L for men, 34 U/L for women.
  9. Gamma-glutamyl transpeptidase (GGT) value of <55 U/L for men, <38 U/L for women.
  10. Will be informed in case of any unexpected finding.

Exclusion Criteria:

  1. 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.
  2. Self-admitted human immunodeficiency virus-positive state.
  3. Disease with a life expectancy shorter than 5 years.
  4. Abdominal surgery interfering with gastrointestinal function, upon judgment of the medical doctor, who will decide on in- or exclusion based on the surgery applied.
  5. Use of antibiotics products within 90 days prior to the study.
  6. Use of other medication will be reviewed by a medical doctor, who will decide on in- or exclusion based on the drug(s) used.
  7. Use of laxatives within 14 days prior to the study.
  8. Institutionalized (e.g. hospital or nursing home).
  9. Pregnancy or lactation.
  10. Plan to lose weight or follow a specific diet within the study period.
  11. Alcohol intake >14 units/week.
  12. Drug use.
  13. Blood donation within 30 days prior to the study.
  14. 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.
  15. History of side effects towards intake of prebiotic supplements.
  16. Self-admitted lactose intolerance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077529


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Wageningen University
Investigators
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Principal Investigator: A.A.M. Masclee Maastricht University Medical Center

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03077529     History of Changes
Other Study ID Numbers: 163046
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No