Analysis of the Impact of Used Probiotic Strains and Diet on Body Composition, Cardiopulmonary Efficiency and the Incidence of Gastrointestinal Disorders in Runners

NCT04530929 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-08-28

No results posted yet for this study

Summary

The aim of the study was to assess the diet and the effect of probiotic therapy on reducing the incidence of gastrointestinal disorders and selected parameters determining the inflammation of the body, body composition, cardiopulmonary efficiency and selected serum biochemical parameters.

70 competitors took part in the study. The research was carried out at the Department of Dietetics and Clinical Nutrition (Medical University of Bialystok), Fitness Club Maniac Gym in Bialystok, as well as at the Hematological Diagnostics Department and the Biochemical Diagnostics Department of the University Teaching Hospital in Bialystok.

The study was randomized using a double-blind trial. 35 persons selected in the draw were G1 group and the remaining G2 group (n=35). The intervention factor was the SANPROBI BARRIER multi-strain probiotic or placebo. Competitors used probiotic/ placebo for three months at a dose of 2x2 capsules daily (2.5 x 10 9 CFU / g (1 capsule)). The consent of the Bioethics Committee of the Medical University, no. RI-002/81/2017, was obtained for the study.

The study consisted of two stages (W1 and W2), and each stage was associated with three visits by the participants. The first of these (W1) included qualification for the study, completing the questionnaire and 3-day nutrition diaries. At the second visit, body composition analysis and cardiopulmonary efficiency test on a medical treadmill were performed. For morphological tests (blood count with smear, lipid profile, fasting glucose, C-reactive protein and ionogram) at the third visit for each competitor was collected blood from the vein in the amount of 10 ml. The final stage (W2) included similar three visits, where the first visit was made after 3 months of taking product A or B. 66 competitors took part in it.

Conditions

  • Gastrointestinal Disorder, Functional

Interventions

DIETARY_SUPPLEMENT

SANPROBI BARRIER

Competitors used probiotic for three months at a dose of 2x2 capsules daily (2.5 x 109 CFU / g (1 capsule)).

DIETARY_SUPPLEMENT

PLACEBO

Competitors used placebo for three months at a dose of 2x2 capsules daily.

Sponsors & Collaborators

  • Maniac Gym Bialystok

    collaborator UNKNOWN
  • University Teaching Hospital, Bialystok

    collaborator UNKNOWN
  • Medical University of Bialystok

    lead OTHER

Principal Investigators

  • Joanna Smarkusz-Zarzecka, PhD · Department of Dietetics and Clinical Nutrition, Medical University of Bialystok

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04530929 on ClinicalTrials.gov