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The Effect of Prebiotics on Endurance Performance

Primary Purpose

Microtia

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Prebiotic
Placebo
Sponsored by
Maastricht University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microtia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prebiotic intervention group

Placebo control group

Arm Description

Prebiotic supplementation

Maltodextrin

Outcomes

Primary Outcome Measures

Time to Exhaustion
Time on cycle ergometer until exhaustion

Secondary Outcome Measures

Gut microbiota composition
Composition of the gut microbiota by faecal sample analysis
Plasma short chain fatty acids
Short chain fatty acids in plasma
Blood glucose
Fasted blood glucose
Insulin
Fasted insulin
Intestinal permeability by sugar test
Intestinal permeability measured by a sugar drink test

Full Information

First Posted
May 5, 2021
Last Updated
June 23, 2021
Sponsor
Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT04946578
Brief Title
The Effect of Prebiotics on Endurance Performance
Official Title
Modulation of the Intestinal Microbiome, and Its Effects on Endurance Exercise Capacity in Moderately Trained Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
August 23, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microtia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study conforms to a randomized, single-blinded, placebo-controlled parallel study design.
Masking
Participant
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prebiotic intervention group
Arm Type
Experimental
Arm Description
Prebiotic supplementation
Arm Title
Placebo control group
Arm Type
Placebo Comparator
Arm Description
Maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotic
Intervention Description
6 weeks of prebiotic supplementation twice a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
6 weeks of maltodextrin supplementation twice a day
Primary Outcome Measure Information:
Title
Time to Exhaustion
Description
Time on cycle ergometer until exhaustion
Time Frame
From baseline to end of the study (up to max 45 days)
Secondary Outcome Measure Information:
Title
Gut microbiota composition
Description
Composition of the gut microbiota by faecal sample analysis
Time Frame
From baseline to end of the study (up to max 45 days)
Title
Plasma short chain fatty acids
Description
Short chain fatty acids in plasma
Time Frame
From baseline to end of the study (up to max 45 days)
Title
Blood glucose
Description
Fasted blood glucose
Time Frame
From baseline to end of the study (up to max 45 days)
Title
Insulin
Description
Fasted insulin
Time Frame
From baseline to end of the study (up to max 45 days)
Title
Intestinal permeability by sugar test
Description
Intestinal permeability measured by a sugar drink test
Time Frame
From baseline to end of the study (up to max 45 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Freddy Troost, Dr.
Phone
+31(0)43 3884296
Email
f.troost@maastrichtuniversity.nl
Facility Information:
Facility Name
Maastricht University
City
Maastricht
State/Province
Limburg
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Prebiotics on Endurance Performance

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