The Effect of Prebiotics on Endurance Performance

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

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.

Study Overview

• Status: Recruiting
• Conditions: Microtia
• Intervention / Treatment: Dietary supplement: Prebiotic; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Freddy Troost, dr.; Phone Number: +31(0)43 3884296; Email: f.troost@maastrichtuniversity.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands
      • Recruiting
      • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prebiotic intervention group; Prebiotic supplementation	Dietary supplement: Prebiotic; 6 weeks of prebiotic supplementation twice a day
Placebo Comparator: Placebo control group; Maltodextrin	Other: Placebo; 6 weeks of maltodextrin supplementation twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Exhaustion	Time on cycle ergometer until exhaustion	From baseline to end of the study (up to max 45 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota composition	Composition of the gut microbiota by faecal sample analysis	From baseline to end of the study (up to max 45 days)
Plasma short chain fatty acids	Short chain fatty acids in plasma	From baseline to end of the study (up to max 45 days)
Blood glucose	Fasted blood glucose	From baseline to end of the study (up to max 45 days)
Insulin	Fasted insulin	From baseline to end of the study (up to max 45 days)
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)

Collaborators and Investigators

• Sponsor: Maastricht University

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2020
• Primary Completion (Anticipated): August 23, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Otorhinolaryngologic Diseases; Ear Diseases; Congenital Microtia
• Other Study ID Numbers: Sport and microbiota

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No