The Effect of Prebiotics on Endurance Performance

NCT04946578 | Unknown DMC

• 1 other identifier: Sport and microbiota
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Microtia

Outcome Measures

Primary Outcomes (1)

• Time to Exhaustion

  Time on cycle ergometer until exhaustion

  From baseline to end of the study (up to max 45 days)

Secondary Outcomes (5)

• Gut microbiota composition

  From baseline to end of the study (up to max 45 days)

• Plasma short chain fatty acids

  From baseline to end of the study (up to max 45 days)

• Blood glucose

  From baseline to end of the study (up to max 45 days)

• Insulin

  From baseline to end of the study (up to max 45 days)

• Intestinal permeability by sugar test

  From baseline to end of the study (up to max 45 days)

Study Arms (2)

Prebiotic intervention group

EXPERIMENTAL

Prebiotic supplementation

Dietary Supplement: Prebiotic

Placebo control group

PLACEBO COMPARATOR

Maltodextrin

Other: Placebo

Interventions

Prebiotic DIETARY_SUPPLEMENT

6 weeks of prebiotic supplementation twice a day

Prebiotic intervention group

Placebo OTHER

6 weeks of maltodextrin supplementation twice a day

Placebo control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, Netherlands

RECRUITING

MeSH Terms

Conditions

Congenital Microtia

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Central Study Contacts

Freddy Troost, Dr.

CONTACT

+31(0)43 3884296; f.troost@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study conforms to a randomized, single-blinded, placebo-controlled parallel study design.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: July 1, 2021
• Study Start: August 24, 2020
• Primary Completion: August 23, 2021
• Study Completion: September 30, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)