The Effect of Prebiotics on Endurance Performance

Microtia Clinical Trial

Official title:

Modulation of the Intestinal Microbiome, and Its Effects on Endurance Exercise Capacity in Moderately Trained Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04946578
• Other study ID #: Sport and microbiota
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: June 2021
• Source: Maastricht University
• Contact: Freddy Troost, Dr.
• Phone: +31(0)43 3884296
• Email: f.troost[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effect of a six-week period personalised food intervention with prebiotic supplementation on intense exercise performance in healthy, recreationally active adults.

Description:

The study conforms to a randomized, single-blinded, placebo-controlled parallel study design. a prebiotic supplement will be selected based on a participants gut microbiota. 1 sachet of prebiotic or placebo will be given twice a day over a period of 6 weeks. Before the start of the study, a VO2max test will be performed. Subjects will bring faecal samples which is collected at home. A time to exhaustion of approximately 80% of their VO2max will be performed at baseline and after the 6 weeks intervention period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: September 30, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male or female 18 - 40 y
• BMI range 18.5 - 25 kg/m2
• Recreational active (performing non-competitive physical endurance exercise at least two times per week with a minimum duration of 60 minutes per exercise bout)

Exclusion Criteria:

• Smoking
• Performing regular resistance training (3+ times per week, carrying out progressive overload training)
• Subject following an overly imbalanced or restrictive diet as per nutritional advice
• Participants who received antibiotics in the 90 days prior to the start of the study
• Self-admitted lactose intolerance
• Administration of probiotic or prebiotic supplements in the 14 days prior to the study

Related Conditions & MeSH terms

• Microtia

Intervention

Dietary Supplement:
• Prebiotic
6 weeks of prebiotic supplementation twice a day

Other:
• Placebo
6 weeks of maltodextrin supplementation twice a day

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Exhaustion	Time on cycle ergometer until exhaustion	From baseline to end of the study (up to max 45 days)
Secondary	Gut microbiota composition	Composition of the gut microbiota by faecal sample analysis	From baseline to end of the study (up to max 45 days)
Secondary	Plasma short chain fatty acids	Short chain fatty acids in plasma	From baseline to end of the study (up to max 45 days)
Secondary	Blood glucose	Fasted blood glucose	From baseline to end of the study (up to max 45 days)
Secondary	Insulin	Fasted insulin	From baseline to end of the study (up to max 45 days)
Secondary	Intestinal permeability by sugar test	Intestinal permeability measured by a sugar drink test	From baseline to end of the study (up to max 45 days)