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Completed

NCT Number: NCT05367804

Dietary Protein Impact on Human Gut Health

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus USÖ, Örebro University

Örebro, 70362, Sweden

About this study

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 production. The subjects eligible to take part in this study will consume an isolated plant protein for 4 weeks, in each week the amount of protein supplementation will increase. The protein will be provided as a powder in opaque bags and participants will be instructed to dissolve the contained powder in liquids (as water) or on their food (e.g., yogurt, oat porridge). The baseline will consist in 4 visits, which in all visits faecal samples will be collected by themselves at their house or at hospital, using materials provided by the study staff. In one baseline visits (visit 4) in addition to the faecal sample, urinary sample will be collected by themselves, and blood samples will be collected at the hospital. After that, subjects will have the dietary intervention for four weeks and more 4 visits. For the visits with blood collection (visits 4 to 8), subjects will come to the study centre after 10 hours overnight fast. Subjects will have anthropometry measurements taken in the visits 4, 5, 6, and 7 using a Tanita® full body composition. Subjects will respond to questionnaires about their physical activity (once a week), Gastrointestinal Symptom rating scale (GSRS - once a week) and track their intestinal habits using Bristol scale (every day). Subjects' diet will be assessed using a web-based 24-hour diet recall (interviewed so the participants learn how to use the tool regardless of where they are) followed by multiple day records (3 times week).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

Isolated Pea Protein

Dietary Supplement

The subjects eligible to take part in this study will consume an isolated plant protein for 4 weeks (week 4 to 8), in each week the amount of protein supplementation will increase (0.25 to 1.0 g of protein per kg of body weight). The protein will be provided as a powder in opaque bags and participants will be instructed to dissolve the contained powder in liquids (as water) or on their food (e.g., yogurt, oat porridge). The baseline will consist of 4 visits (1 to 4) to see how stable are the baseline results.

Primary outcomes

  1. Changes in the faecal metabolites using targeted and untargeted metabolomics

    Time frame: 8 weeks

    Difference in faecal metabolites depending on the protein supplementation amount. Targeted and untargeted metabolomics measurements will be used (e.g., short-chain fatty acids and branched chain fatty acids analyses, and polar and non polar metabolomics). Faecal samples will have their metabolites extracted and quantified by liquid chromatography coupled with high-resolution time-of-flight mass spectrometry (UHPLC-qToF-MS), and gas chromatography coupled with high-resolution mass spectroscopy (GC-Orbitrap). The level of metabolites will be compared throughout the whole study.

  2. Routinely analysed markers for protein intake/compliance - urine

    Time frame: 5 weeks

    Difference in 24 h urine samples markers due to the protein supplementation (e.g., for 24 h urine: urea nitrogen from 24 h urine, creatinine, uric acid)

  3. Routinely analysed markers for protein intake/compliance - blood

    Time frame: 5 weeks

    Difference in blood (serum) samples markers due to the protein supplementation (e.g., urea and creatinine)

Secondary outcomes

  1. Food intake using food diaries

    Time frame: 8 weeks

    Food diaries 3 times a week

  2. Changes in the gut microbiota profile during the baseline period

    Time frame: 4 weeks

    Difference in the gut microbiota profile/composition during the baseline period will be assessed by 16s/NGS (next-generation sequencing). Alpha and Beta diversity will be measured and compared throughout these 4 weeks of baseline.

  3. Changes in the faecal metabolites during the baseline period

    Time frame: 4 weeks

    The difference in the metabolites profile during the baseline will be assessed by targeted and untargeted metabolomics. Targeted and untargeted metabolomics measurements will be used (e.g., short-chain fatty acids and branched chain fatty acids analyses and polar and non-polar metabolomics). Faecal samples will have their metabolites extracted and quantified by liquid chromatography coupled with high-resolution time-of-flight mass spectrometry (UHPLC-qToF-MS), and gas chromatography coupled with high-resolution mass spectroscopy (GC-Orbitrap). The level of metabolites will be compared during the baseline period.

  4. Profile/composition of the gut microbiota during the intervention

    Time frame: 5 weeks

    Difference in the gut microbiota profile/composition because of the protein supplementation will be assessed by 16s/NGS. Alpha and Beta diversity will be measured and compared throughout the 5 weeks of intervention.

  5. Assessment of the Gastrointestinal Symptom rating scale (GSRS) during the study

    Time frame: 8 weeks

    The gastrointestinal symptoms will be assessed during the baseline and protein supplementation period. Difference in the frequency and severity of gastrointestinal symptoms during the study will be assessed (15 questions with a scale of 1-7, minimum value 1, maximum 7, higher score correspond to a worse outcome)

  6. Assessment of the bowel movement using the Bristol scale diary

    Time frame: 8 weeks

    The bowel movement will be assessed during the baseline and protein supplementation period by the Bristol scale diary. In the diary they write down the type of stool based on the scale which shows 7 pictures of different forms of stool, from watery diarrhea to compact. Participants are asked to choose the form of stool they have every day during the study.

  7. Assessment of physical activity level

    Time frame: 8 weeks

    To assess the maintenance or difference of physical activity level during the baseline and dietary intervention by the AKTIVITETSVANOR questionnaire (Swedish questionnaire to assess physical activity frequency for 7 days).

  8. Assessment of height

    Time frame: 5 weeks

    The height will be assessed in meters.

  9. Assessment of body composition

    Time frame: 6 weeks

    Participants will be have their body composition measured using Tanita® full body scale. For this their height (m) will be measured and the information will be entered at the Tanita® scale. The obtained results by Tanita are: weight (kg), muscle mass (% and kg), body water content (% and kg), fat mass (% and kg), basal energy expenditure (kcal and kJ) and BMI in kg/m^2.

  10. Assessment of body weight during the study

    Time frame: 6 weeks

    Participants will be weighted in order to have information of their body weight changes in kilograms during the study.

  11. Concentrations of faecal calprotectin

    Time frame: 5 weeks

    Difference in faecal levels of calprotectin during the study intervention

  12. Concentration of glucose

    Time frame: 5 weeks

    Measurement of glucose in blood samples

  13. Concentration of insulin

    Time frame: 5 weeks

    Measurement of insulin in blood samples

  14. Concentration of C-reactive protein

    Time frame: 5 weeks

    Measurement of C-reactive protein in blood samples

  15. Concentration of cholesterol (total, LDL, and HDL)

    Time frame: 5 weeks

    Measurement of cholesterol (total, LDL, and HDL) in blood samples

  16. Concentration of triglycerides

    Time frame: 5 weeks

    Measurement of triglycerides in blood samples

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Official study title

Växtbaserade Proteiner påverkan på människors tarmhälsa Dietary Protein Impact on Human Gut Health

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 10, 2022
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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