NCT05726435

Brief Summary

Athlete nutrition is becoming an increasingly important factor on the path to achieving top results. Nutrients such as soluble fiber can alter the intestinal microbiota, resulting in metabolites with a positive effect on metabolism. Thus, the fibers become available, an additional source of energy to the host, have an anti-stress effect and delay the feeling of fatigue. The primary goal of the study is to determine the impact of soluble dietary fiber on increasing athletic efficiency, the secondary goal is to determine the impact of fiber on delaying fatigue. Subjects will be randomly divided into experimental and control group. The sample of variables will consist of genome microbiota genome sequencing data, measures to assess morphological characteristics, lower extremity explosive strength tests, and cardiovascular endurance. The statistical package SPSS will be used for data processing. The expected scientific contribution of this research is to expand the scientific knowledge about the importance of dietary fiber in the diet of athletes with the aim of improving sports performance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

July 13, 2021

Last Update Submit

February 1, 2023

Conditions

Keywords

FiberGastrointestinal MicrobiotaNutrition16S rRNA sequencingPerformance

Outcome Measures

Primary Outcomes (3)

  • Rapid microbiota change

    The impact of fiber supplementation on gut microbiome shall assessed through monitoring of relative taxonomic abundance of bacteria that compose gut microbiota. DNA shall be extracted from collected faecal samples, stored at -80°C. DNA extraction shall be performed using the QIAamp® PowerFecal® DNA Kit. DNA concentration shall be quantified using Promega Quantus Flourometer before being sent to amplicon sequencing of variable regions 3 and 4 of the 16S rRNA gene with the primer set 341F (5'-CCTAYGGGRBGCASCAG -3') 806R (5'- GGACTACNNGGGTATCTAAT -3'). Obtained sequenceing raw data (reads) shall be analyzed using 'Quantitative Insights Into Microbial Ecology 2' (QIIME2) software in order to evaluate microbial composition of each sample. The comparison on intial sample (before intervention) and sample 1 (after 2 weeks) of supplementation shall provide a baseline insight into eventual rapid microbiota change as a response to supplementation/placebo.

    2 weeks

  • Altered microbiota composition

    Prolonged supplementation after initial 2 weeks will support the established altered gut microbiota in participants receiving fiber supplement. The impact of fiber supplementation on gut microbiome shall assessed through monitoring of relative taxonomic abundance of bacteria that compose gut microbiota. Gut microbiota DNA shall be extracted from collected faecal samples, stored at -80°C. DNA shall be processed in the same manner as previously described (Outcome 1). Obtained sequenceing raw data (reads) shall be analyzed using 'Quantitative Insights Into Microbial Ecology 2' (QIIME2) software in order to evaluate microbial composition of each sample. The comparison on intial sample (before intervention) and sample 2 (after 4 weeks) of supplementation shall provide an insight into eventual microbiota change as a response to prolonged supplementation/placebo.

    4 weeks

  • Effect on the perception of fatigue

    The major question is whether the moderately increasing fiber intake in athletes has the potential to support the intestinal microbiota and conversely positively impact training-induced perception of fatigue. In order to understand the impact of fiber consumption on the perception of fatigue, after each training session or match, the participants shall be asked to record and send a rating of perceived exertion through a mobile messaging application. The Borg's CR10 RPE scale shall be used for this purpose. This scale has a range from 0 to 10 (RPE - Rating of Perceived Exertion). The RPE scale is a tool used to monitor the perceptual response to training, as a method of determining physical exertion during exercise. The original RPE scale, developed more than 40 years ago, was primarily used to monitor aerobic load, but it still remains widely used in athlete tracking.

    4 weeks

Secondary Outcomes (1)

  • Long-term microbiota impact

    8 weeks

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

Seven randomly selected active basketball players will be supplemented with defined prebiotic fibre (20 grams per day divided in two 10 gram doses - 85% total fiber content) for the total duration of 4 weeks, while being stationed in the training camp under constant coach and nutrition expert surveillance.

Dietary Supplement: Soluble dietary fiber with prebiotic properties

Control group

PLACEBO COMPARATOR

Seven randomly selected active basketball players will be supplemented with placebo resembling prebiotic fibre in all visible and taste aspects (20 grams per day divided in two 10 gram doses) for the total duration of 4 weeks, while being stationed in the training camp under constant coach and nutrition expert surveillance.

Dietary Supplement: Placebo

Interventions

14 adult professional baskeyball players will be divided randomly in two groups, each containing 7 players. One group shall receive Nutriose fiber, two times per day 10 grams per dose in total duration of 4 weeks. Second group shall receive same amount of Placebo in form of Maltodextrin. Each group will undergo a series of sports performance tests and questionnaires and shall donate their feces several times during the study in order to monitor gut microbiota changes. The Nutriose group in this particular intervention contains 7 randomy selected players.

Also known as: Nutriose
Experimental group
PlaceboDIETARY_SUPPLEMENT

14 adult professional baskeyball players will be divided randomly in two groups, each containing 7 players. One group shall receive Nutriose fiber, two times per day 10 grams per dose in total duration of 4 weeks. Second group shall receive same amount of Placebo in form of Maltodextrin. Each group will undergo a series of sports performance tests and questionnaires and shall donate their feces several times during the study in order to monitor gut microbiota changes. This second (Placebo) group also consists of the 7 players and receives Maltodextrin supplementation. Since the study type is "double-blind", neither the participants (players) nor the person handing out the supplementation know the exact nature of fiber substance being handed during the entire duration of the trial. Independent statistician is handling the randomization of both interventions.

Also known as: Maltodextrin
Control group

Eligibility Criteria

Age18 Years - 22 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Professional basketball players from the same team participating in the same monitored training process

You may not qualify if:

  • Diabetes or other chronic disease, taking sports performance enhancing drugs, taking antibiotics 3 months prior or during the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Food Technology and Biotechnology

Zagreb, 10000, Croatia

Location

Related Publications (11)

  • Wosinska L, Cotter PD, O'Sullivan O, Guinane C. The Potential Impact of Probiotics on the Gut Microbiome of Athletes. Nutrients. 2019 Sep 21;11(10):2270. doi: 10.3390/nu11102270.

    PMID: 31546638BACKGROUND
  • Marttinen M, Ala-Jaakkola R, Laitila A, Lehtinen MJ. Gut Microbiota, Probiotics and Physical Performance in Athletes and Physically Active Individuals. Nutrients. 2020 Sep 25;12(10):2936. doi: 10.3390/nu12102936.

    PMID: 32992765BACKGROUND
  • Clark A, Mach N. Exercise-induced stress behavior, gut-microbiota-brain axis and diet: a systematic review for athletes. J Int Soc Sports Nutr. 2016 Nov 24;13:43. doi: 10.1186/s12970-016-0155-6. eCollection 2016.

    PMID: 27924137BACKGROUND
  • Mohr AE, Jager R, Carpenter KC, Kerksick CM, Purpura M, Townsend JR, West NP, Black K, Gleeson M, Pyne DB, Wells SD, Arent SM, Kreider RB, Campbell BI, Bannock L, Scheiman J, Wissent CJ, Pane M, Kalman DS, Pugh JN, Ortega-Santos CP, Ter Haar JA, Arciero PJ, Antonio J. The athletic gut microbiota. J Int Soc Sports Nutr. 2020 May 12;17(1):24. doi: 10.1186/s12970-020-00353-w.

    PMID: 32398103BACKGROUND
  • Erdogan Z, Erdogan S, Aslantas O, Celik S. Effects of dietary supplementation of synbiotics and phytobiotics on performance, caecal coliform population and some oxidant/antioxidant parameters of broilers. J Anim Physiol Anim Nutr (Berl). 2010 Oct;94(5):e40-8. doi: 10.1111/j.1439-0396.2009.00973.x.

    PMID: 20487099BACKGROUND
  • Lefranc-Millot C, Guerin-Deremaux L, Wils D, Neut C, Miller LE, Saniez-Degrave MH. Impact of a resistant dextrin on intestinal ecology: how altering the digestive ecosystem with NUTRIOSE(R), a soluble fibre with prebiotic properties, may be beneficial for health. J Int Med Res. 2012;40(1):211-24. doi: 10.1177/147323001204000122.

    PMID: 22429361BACKGROUND
  • Farhangi MA, Javid AZ, Sarmadi B, Karimi P, Dehghan P. A randomized controlled trial on the efficacy of resistant dextrin, as functional food, in women with type 2 diabetes: Targeting the hypothalamic-pituitary-adrenal axis and immune system. Clin Nutr. 2018 Aug;37(4):1216-1223. doi: 10.1016/j.clnu.2017.06.005. Epub 2017 Jun 10.

    PMID: 28669666BACKGROUND
  • Aliasgharzadeh A, Dehghan P, Gargari BP, Asghari-Jafarabadi M. Resistant dextrin, as a prebiotic, improves insulin resistance and inflammation in women with type 2 diabetes: a randomised controlled clinical trial. Br J Nutr. 2015 Jan 28;113(2):321-30. doi: 10.1017/S0007114514003675.

    PMID: 27028002BACKGROUND
  • Li S, Guerin-Deremaux L, Pochat M, Wils D, Reifer C, Miller LE. NUTRIOSE dietary fiber supplementation improves insulin resistance and determinants of metabolic syndrome in overweight men: a double-blind, randomized, placebo-controlled study. Appl Physiol Nutr Metab. 2010 Dec;35(6):773-82. doi: 10.1139/H10-074.

    PMID: 21164548BACKGROUND
  • Guerin-Deremaux L, Pochat M, Reifer C, Wils D, Cho S, Miller LE. The soluble fiber NUTRIOSE induces a dose-dependent beneficial impact on satiety over time in humans. Nutr Res. 2011 Sep;31(9):665-72. doi: 10.1016/j.nutres.2011.09.004.

    PMID: 22024490BACKGROUND
  • Nazare JA, Sauvinet V, Normand S, Guerin-Deremaux L, Gabert L, Desage M, Wils D, Laville M. Impact of a resistant dextrin with a prolonged oxidation pattern on day-long ghrelin profile. J Am Coll Nutr. 2011 Feb;30(1):63-72. doi: 10.1080/07315724.2011.10719945.

    PMID: 21697540BACKGROUND

MeSH Terms

Interventions

NUTRIOSEmaltodextrin

Study Officials

  • Antonio Starcevic, PhD

    University of Zagreb, Faculty of Food Technology and Biotechnology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Program is used to make random selection and grouping of participants in two groups: experimental one receiving fiber and control one, receiving placebo. A research assistant who is not involved in study (neither design nor implementation) will pack prebiotic/placebo daily doses (20 grams/day) and provide nutritionist who is one of the investigators with doses for each participant. Only when the study is completed and all results processed will the information on who received fiber/placebo be released.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Double-blind study of defined prebiotic supplementation for active basketball players investigating fiber effect on microbiota composition and delayed feeling of fatigue. There are two arms, active one receiving prebiotic fibre and control one receiving placebo. Each arm contains 7 randomly selected participants who signed informed consent and will receive supplementation during 4 weeks in total while being in the same training camp and under same training conditions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 13, 2021

First Posted

February 14, 2023

Study Start

September 1, 2021

Primary Completion

October 31, 2021

Study Completion

December 20, 2021

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations