Status:

COMPLETED

Dietary Protein Impact on Human Gut Health

Lead Sponsor:

Örebro University, Sweden

Conditions:

Healthy

Eligibility:

All Genders

18-45 years

Phase:

NA

Brief Summary

The overall aim of this project is to evaluate the quantity of dietary protein that affects gut protein metabolization and if the baseline measurements are stable.

Detailed Description

Healthy male and female adult subjects (n=39) will be recruited to take part in an evaluation study to determine the amount of dietary protein intake which influences gut-protein-derived metabolites p...

Eligibility Criteria

Inclusion

  • Age 18-45 years
  • Body mass index (BMI) 18,5-30 kg/m2
  • Weight stable within the previous 3 months
  • Maintenance of the usual physical activity habits during the study
  • Intake of fibre between 15 and 25 g per day (evaluated by 3 food diaries or 24-hours recalls)
  • Omnivores

Exclusion

  • Acute chronic disease, inflammatory or functional gastrointestinal diseases and any other disease or disorder that could affect the outcome of the study
  • Use of a medication that may interfere the study outcome
  • Eating disorder
  • High protein intake (more than 15% of energy or maximum 1,2 g of protein per kg of body weight per day; evaluated by 3 food diaries or 24-hours recalls)
  • Use of antibiotic medication during the last 3 months prior the first visit
  • Use of antibiotic medication very early in life (e.g., asthmatic children or ear inflammation)
  • Use of laxative or anti-diarrhoea medication within the past 3 months before the study
  • Regular consumption of probiotic or prebiotic product for the past 6 weeks before the study
  • Special diet that is considered to affect the study participation and/or study results, for example, high protein diets
  • More than 5 h of moderate-vigorous exercise per week
  • Pregnancy or breastfeeding
  • Intolerance to dietary supplements that will be used in the study
  • Smoking
  • Abuse of alcohol or drugs (according to AUDIT score)

Key Trial Info

Start Date :

October 27 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2022

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT05367804

Start Date

October 27 2021

End Date

June 1 2022

Last Update

April 28 2023

Active Locations (1)

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1

Campus USÖ, Örebro University

Örebro, Sweden, 70362