HealthyNCT05367804
Dietary Protein Impact on Human Gut Health
A study testing Isolated pea protein in people with Healthy, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Isolated pea protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- 27 Oct 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Växtbaserade Proteiner påverkan på människors tarmhälsa 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.
Read the 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 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).
- Conditions
- Healthy
- Being tested
- Isolated pea protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated pea proteinDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Isolated plant protein | Experimental | Visit 1 to 8 participants will collect faecal samples. Visits 4 to 8 in addition to the faecal sample, urinary samples (24 h urine collection) will be collected by themselves, and blood sample will be collected at the hospital. For the visits with blood collection (visits 4 to 8), subjects will come to the study centre after 10 hours of 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 a week). Receives: Dietary Supplement: Isolated pea protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the faecal metabolites using targeted and untargeted metabolomics
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.
Measured: 8 weeks
Routinely analysed markers for protein intake/compliance - urine
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)
Measured: 5 weeks
Routinely analysed markers for protein intake/compliance - blood
Difference in blood (serum) samples markers due to the protein supplementation (e.g., urea and creatinine)
Measured: 5 weeks
Secondary outcomes (16)
Food intake using food diaries
Food diaries 3 times a week
Measured: 8 weeks
Changes in the gut microbiota profile during the baseline period
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.
Measured: 4 weeks
Changes in the faecal metabolites during the baseline period
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.
Measured: 4 weeks
Profile/composition of the gut microbiota during the intervention
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.
Measured: 5 weeks
Assessment of the Gastrointestinal Symptom rating scale (GSRS) during the study
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)
Measured: 8 weeks
Assessment of the bowel movement using the Bristol scale diary
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.
Measured: 8 weeks
Assessment of physical activity level
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).
Measured: 8 weeks
Assessment of height
The height will be assessed in meters.
Measured: 5 weeks
Assessment of body composition
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.
Measured: 6 weeks
Assessment of body weight during the study
Participants will be weighted in order to have information of their body weight changes in kilograms during the study.
Measured: 6 weeks
Concentrations of faecal calprotectin
Difference in faecal levels of calprotectin during the study intervention
Measured: 5 weeks
Concentration of glucose
Measurement of glucose in blood samples
Measured: 5 weeks
Concentration of insulin
Measurement of insulin in blood samples
Measured: 5 weeks
Concentration of C-reactive protein
Measurement of C-reactive protein in blood samples
Measured: 5 weeks
Concentration of cholesterol (total, LDL, and HDL)
Measurement of cholesterol (total, LDL, and HDL) in blood samples
Measured: 5 weeks
Concentration of triglycerides
Measurement of triglycerides in blood samples
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start27 Oct 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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 production. The study consists of 8 weeks with weekly visits and the subjects will consume an isolated plant-protein for 4 weeks (week 4 to 8), in each week the amount of protein supplementation will increase. Faecal samples will be used to answer the main outcome of gut metabolites and microbiota profile. And the blood and urine samples to measure health status and compliance (protein intake markers). Questionnaires will be used to access gastrointestinal symptoms and bowel movement, physical activity level and dietary intake.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Jan Brummer, MD, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367804
- Sponsor's protocol ID
- PanProtein
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Växtbaserade Proteiner påverkan på människors tarmhälsa Dietary Protein Impact on Human Gut Health
- ClinicalTrials.gov ID
- NCT05367804
- Acronym / sponsor ID
- PanProtein
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model 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 production. The study consists of 8 weeks with weekly visits and the subjects will consume an isolated plant-protein for 4 weeks (week 4 to 8), in each week the amount of protein supplementation will increase. Faecal samples will be used to answer the main outcome of gut metabolites and microbiota profile. And the blood and urine samples to measure health status and compliance (protein intake markers). Questionnaires will be used to access gastrointestinal symptoms and bowel movement, physical activity level and dietary intake.
| Arm | Type | Receives |
|---|---|---|
| Isolated plant protein | Experimental | Dietary Supplement: Isolated pea proteinVisit 1 to 8 participants will collect faecal samples. Visits 4 to 8 in addition to the faecal sample, urinary samples (24 h urine collection) will be collected by themselves, and blood sample will be collected at the hospital. For the visits with blood collection (visits 4 to 8), subjects will come to the study centre after 10 hours of 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 a week). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isolated pea proteinThe 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. | Dietary supplement | Isolated plant protein |
Primary outcome
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.
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)
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)
16 secondary outcomes
Food intake using food diaries
Time frame: 8 weeks
Changes in the gut microbiota profile during the baseline period
Time frame: 4 weeks
Changes in the faecal metabolites during the baseline period
Time frame: 4 weeks
Profile/composition of the gut microbiota during the intervention
Time frame: 5 weeks
Assessment of the Gastrointestinal Symptom rating scale (GSRS) during the study
Time frame: 8 weeks
Assessment of the bowel movement using the Bristol scale diary
Time frame: 8 weeks
Assessment of physical activity level
Time frame: 8 weeks
Assessment of height
Time frame: 5 weeks
Assessment of body composition
Time frame: 6 weeks
Assessment of body weight during the study
Time frame: 6 weeks
Concentrations of faecal calprotectin
Time frame: 5 weeks
Concentration of glucose
Time frame: 5 weeks
Concentration of insulin
Time frame: 5 weeks
Concentration of C-reactive protein
Time frame: 5 weeks
Concentration of cholesterol (total, LDL, and HDL)
Time frame: 5 weeks
Concentration of triglycerides
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Jan Brummer, MD, PhD principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolated pea protein in people with Healthy, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the faecal metabolites using targeted and untargeted metabolomics (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.