NCT03077529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2018

Completed
Last Updated

September 7, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

March 3, 2017

Last Update Submit

September 6, 2018

Conditions

Healthy Young AdultsPrefrail Elderly

Outcome Measures

Primary Outcomes (2)

  • Microbial composition

    Microbiota composition and functional capacity as measured by HiSeq sequencing of fecal 16S rRNA genes.

    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.

    Change from baseline to four weeks supplementation, of each intervention period

Study Arms (2)

Galacto-oligosaccharide

EXPERIMENTAL

During this period subjects will receive 5.65 grams of Vivinal GOS supplements three times daily for four weeks

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

Dietary Supplement: Maltodextrin

Interventions

Galacto-oligosacchrideDIETARY_SUPPLEMENT

During this period subjects will receive 5.65 grams of Vivinal GOS supplements three times daily for four weeks

Galacto-oligosaccharide
MaltodextrinDIETARY_SUPPLEMENT

During this period subjects will receive 7.24 grams of maltodextrin supplements three times daily for four weeks

Maltodextrin

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • Use of antibiotics products within 90 days prior to the study.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 33509667DERIVED

MeSH Terms

Interventions

maltodextrin

Study Officials

  • A.A.M. Masclee

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 13, 2017

Study Start

March 20, 2017

Primary Completion

September 6, 2018

Study Completion

September 6, 2018

Last Updated

September 7, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)