NCT03077529

GOS and Microbial Fermentation in Aging

Impact of Galacto-oligosaccharides on Microbial Fermentation Capacity and Markers of Frailty in Healthy Adults and Elderly

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 25 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Young Adults
• Prefrail Elderly

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Galacto-oligosacchride	During this period subjects will receive 5.65 grams of Vivinal GOS 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

Timeline

• Start date: 2017-03-20
• Primary completion: 2018-09-06
• Completion: 2018-09-06
• First posted: 2017-03-13
• Last updated: 2018-09-07

Locations

1 site across 1 country: Netherlands