HealthyNCT05611138
Dietary Proteins: Metagenomic and Metabolomics Approaches for Human Biomarkers Identification
A study testing Protein supplementation in people with Healthy, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
This project aims to create a methodological framework, including the discovery and validation of novel biomarker panels to decipher the impact of plant-based protein intake on health biomarkers. 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?
- Protein supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSweden
- Study dates
- 15 Sep 2022to 14 Apr 2023
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Växtbaserade Proteiners påverkan på tarmhälsa Hos människa
This project aims to create a methodological framework, including the discovery and validation of novel biomarker panels to decipher the impact of plant-based protein intake on health biomarkers. Moreover, the possibility of predicting biomarkers production will be tested by a colonic in vitro fermentation study using study participants' faecal samples.
Read the detailed description
This study consists of a double-blind, randomised, 3-arm parallel trial, consisting of 2-wk baseline measurements, 4-wk intervention period (with weekly sample collection), and 2-wk after-intervention follow-up, with healthy subjects in each arm consuming different protein sources (from plant- or animal-based sources). Subjects that are eligible to take part in this study will be blinded and randomly allocated to consume an isolated pea protein (arm 1), animal protein (arm 2) or more complex protein pea protein powder (arm 3). The isolated plant and animal protein will be used to evaluate the specific effects of the proteins from the different sources. The more complex protein pea protein powder will be used as a more complex food matrix, containing other food components than protein, to assess how other pea components may impact the specific protein effects. Regardless of the differences in their structure, all supplement powders will be adjusted to provide the same amount of protein. The protein calculation will be done exclusively for each participant, based on their body weight (kg). They will consume up to 2 g of protein per body weight per day. Subjects will be asked to maintain their usual diet and their food intake will be accompanied during the intervention.
Participants' compliance will be followed by their food diaries and by clinical markers for protein intake and will collect blood, faeces and 24 h urine samples. A subset of the participants (max. 15 per arm) for visits 2 and 6 will be invited to participate in a postprandial challenge. After the fastening blood sample collection, they will receive the daily protein portion as breakfast. For those, 9 blood sample time points will be taken, being at 0, 15, 30, 60, 90, 120, 150, 180, and 480 min. After the 180 min measurement, they will receive a standard meal as lunch (e.g., pasta with tomato sauce).
- Conditions
- Healthy
- Being tested
- Protein supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementationDietary supplement
Participants will be instructed to dissolve the protein powder in liquids (such as water) or on their food (e.g., yoghurt, oat porridge). A subset of the participants (max. 15 per arm) for visits 2 and 6 will be invited to participate in a postprandial challenge, where they will receive the daily protein portion as breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Isolated pea protein | Experimental | Dietary supplementation with isolated pea protein powder. Amount: 0.5 g of protein from the supplement per kilogram of body weight, taken in 3 portions during the day, for 4 weeks. Receives: Dietary Supplement: Protein supplementation |
| Isolated whey protein | Experimental | Dietary supplementation with isolated whey protein. Amount: 0.5 g of protein from the supplement per kilogram of body weight, taken in 3 portions during the day, for 4 weeks. Receives: Dietary Supplement: Protein supplementation |
| Concentrated pea protein | Experimental | Dietary supplementation with concentrated pea protein Amount: 0.5 g of protein from the supplement per kilogram of body weight, taken in 3 portions during the day, for 4 weeks. Receives: Dietary Supplement: Protein supplementation |
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 during the intervention
Difference in faecal metabolites depending on the protein supplementation amount and from colonic in vitro fermentation. 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
Changes in the plasma metabolites using targete and untargeted metabolomics during the intervention
Difference in plasma metabolites (blood obtained fastened state) depending on the protein supplementation amount. Targeted and untargeted metabolomics measurements will be used (e.g., lipids, and polar and non polar metabolomics). Plasma 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: 4 weeks
Profile/composition of the gut microbiota during the intervention
Difference in the gut microbiota profile/composition because of the protein supplementation and from colonic in vitro fermentation will be assessed by 16s/NGS. Alpha and Beta diversity will be measured and compared throughout the 4 weeks of intervention and baselines. In the case of NGS, the genome sequence will be annotated and the resulting set of genes encoding for metabolic enzymes will be extracted. Data from shotgun metagenomics and metabolomics will be integrated by constructing dependency networks, with a special attempt to infer causal relationships among different variables.
Measured: 8 weeks
Routinely analysed markers for protein intake/compliance during the intervention - 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: 4 weeks
Routinely analysed markers for protein intake/compliance during the intervention - blood
Difference in blood (serum) samples markers due to the protein supplementation (e.g., urea and creatinine)
Measured: 4 weeks
Changes in the plasma metabolites using targeted and untargeted metabolomics during the dietary challenge
Difference in plasma metabolites depending on the protein taken as breaskfast. Targeted and untargeted metabolomics measurements will be used (e.g., polar and non polar metabolomics). Plasma 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 with those found in the fastening state.
Measured: 4 weeks
Colonic in vitro fermentation
Subjects will have their fresh faecal samples used in the colonic in vitro fermentation experiment to evaluate whether and how gut metabolites production can be predicted in vitro. The same proteins used in the dietary intervention study will be digested in vitro and used for the batch in vitro colonic fermentation. Supernatant will be used for metabolomics analysis (outcome 1) and selected fermentation time point pellets will be used for microbiota composition and functional analyses (outcome 3).
Measured: 4 weeks
Secondary outcomes (18)
Food intake using food diaries
Food diaries 3 times a week.
Measured: 8 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: 4 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: 4 weeks
Assessment of body composition
Participants will be have their body composition measured using Tanita® full body 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: 4 weeks
Concentrations of faecal calprotectin
Difference in faecal levels of calprotectin during the study intervention
Measured: 4 weeks
Fasting blood glucose level
Measurement of glucose in blood samples
Measured: 4 weeks
Fasting blood insulin level
Measurement of insulin in blood samples
Measured: 4 weeks
Fasting blood C-reactive protein level
Measurement of C-reactive protein in blood samples
Measured: 4 weeks
Fasting blood cholesterol (total, LDL, and HDL) level
Measurement of cholesterol (total, LDL, and HDL) in blood samples (fasting state)
Measured: 4 weeks
Fasting blood triglycerides level
Measurement of triglycerides in blood samples (fasting state)
Measured: 4 weeks
Concentration of glucose - dietary challenge
Measurement of glucose in blood samples after the dietary challenge to check its level, compare with the fastening state and evaluate the area under the curve.
Measured: 4 weeks
Concentration of insulin - dietary challenge
Measurement of insulin in blood samples after the dietary challenge to check its level, compare with the fastening state and evaluate the area under the curve.
Measured: 4 weeks
Profile/composition of the gut microbiota after the intervention
Difference in the gut microbiota profile/composition 1 and 2 after the protein supplementation will be assessed by 16s/NGS. Alpha and Beta diversity will be measured and compared throughout these 2 weeks after the intervention. In the case of NGS, the genome sequence will be annotated and the resulting set of genes encoding for metabolic enzymes will be extracted. Data from shotgun metagenomics and metabolomics will be integrated by constructing dependency networks, with a special attempt to infer causal relationships among different variables.
Measured: 2 weeks
Changes in the faecal metabolites using targeted and untargeted metabolomics after the intervention
Difference in faecal metabolites levels after the intervention will be measured. 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 after 1 and 2 weeks of taking the protein supplements.
Measured: 2 weeks
Breath test
From the subset of the participants, a breath sample will be collected by having them breathe into a breath sample collecting device (ReCIVA, Owlstone, UK), in order to measure volatile organic compounds by thermal desorption-gas chromatography coupled to ultra-resolution mass spectrometry (TD-GC-HRMS-Orbitrap).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start15 Sep 2022
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy male and female adult subjects (n=87) will be recruited to take part in a double-blinded, randomized, 3-arms parallel trial. Subjects that are eligible to take part in the study will be blinded and randomly allocated to consume an isolated plant protein (arm 1) or isolated animal protein (arm 2) or plant-based source of protein (arm 3). The subjects eligible to take part in this study will consume the proteins for 4 weeks, before the intervention they will have a baseline of two weeks, and after the intervention, they will have more two visits. Faecal and blood samples will be used to answer the main outcome of gut-related metabolites and microbiota profile. Blood and urine samples will be used 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Brummer, MD, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611138
- Sponsor's protocol ID
- PanProtein 2
- Status last verified
- Apr 2023
- First submitted
- 2 Nov 2022
- Last updated
- 28 Apr 2023
- Results posted
- 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 Proteiners påverkan på tarmhälsa Hos människa
- ClinicalTrials.gov ID
- NCT05611138
- Acronym / sponsor ID
- PanProtein 2
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 9 Nov 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.
This project aims to create a methodological framework, including the discovery and validation of novel biomarker panels to decipher the impact of plant-based protein intake on health biomarkers. Moreover, the possibility of predicting biomarkers production will be tested by a colonic in vitro fermentation study using study participants' faecal samples.
Detailed description
This study consists of a double-blind, randomised, 3-arm parallel trial, consisting of 2-wk baseline measurements, 4-wk intervention period (with weekly sample collection), and 2-wk after-intervention follow-up, with healthy subjects in each arm consuming different protein sources (from plant- or animal-based sources). Subjects that are eligible to take part in this study will be blinded and randomly allocated to consume an isolated pea protein (arm 1), animal protein (arm 2) or more complex protein pea protein powder (arm 3). The isolated plant and animal protein will be used to evaluate the specific effects of the proteins from the different sources. The more complex protein pea protein powder will be used as a more complex food matrix, containing other food components than protein, to assess how other pea components may impact the specific protein effects. Regardless of the differences in their structure, all supplement powders will be adjusted to provide the same amount of protein. The protein calculation will be done exclusively for each participant, based on their body weight (kg). They will consume up to 2 g of protein per body weight per day. Subjects will be asked to maintain their usual diet and their food intake will be accompanied during the intervention.
Participants' compliance will be followed by their food diaries and by clinical markers for protein intake and will collect blood, faeces and 24 h urine samples. A subset of the participants (max. 15 per arm) for visits 2 and 6 will be invited to participate in a postprandial challenge. After the fastening blood sample collection, they will receive the daily protein portion as breakfast. For those, 9 blood sample time points will be taken, being at 0, 15, 30, 60, 90, 120, 150, 180, and 480 min. After the 180 min measurement, they will receive a standard meal as lunch (e.g., pasta with tomato sauce).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Healthy male and female adult subjects (n=87) will be recruited to take part in a double-blinded, randomized, 3-arms parallel trial. Subjects that are eligible to take part in the study will be blinded and randomly allocated to consume an isolated plant protein (arm 1) or isolated animal protein (arm 2) or plant-based source of protein (arm 3). The subjects eligible to take part in this study will consume the proteins for 4 weeks, before the intervention they will have a baseline of two weeks, and after the intervention, they will have more two visits. Faecal and blood samples will be used to answer the main outcome of gut-related metabolites and microbiota profile. Blood and urine samples will be used 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 pea protein | Experimental | Dietary Supplement: Protein supplementationDietary supplementation with isolated pea protein powder. Amount: 0.5 g of protein from the supplement per kilogram of body weight, taken in 3 portions during the day, for 4 weeks. |
| Isolated whey protein | Experimental | Dietary Supplement: Protein supplementationDietary supplementation with isolated whey protein. Amount: 0.5 g of protein from the supplement per kilogram of body weight, taken in 3 portions during the day, for 4 weeks. |
| Concentrated pea protein | Experimental | Dietary Supplement: Protein supplementationDietary supplementation with concentrated pea protein Amount: 0.5 g of protein from the supplement per kilogram of body weight, taken in 3 portions during the day, for 4 weeks. |
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 |
|---|---|---|
| Protein supplementationParticipants will be instructed to dissolve the protein powder in liquids (such as water) or on their food (e.g., yoghurt, oat porridge). A subset of the participants (max. 15 per arm) for visits 2 and 6 will be invited to participate in a postprandial challenge, where they will receive the daily protein portion as breakfast. | Dietary supplement | Concentrated pea protein, Isolated pea protein, Isolated whey protein |
Primary outcome
Changes in the faecal metabolites using targeted and untargeted metabolomics during the intervention
Time frame: 8 weeks
Difference in faecal metabolites depending on the protein supplementation amount and from colonic in vitro fermentation. 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.
Changes in the plasma metabolites using targete and untargeted metabolomics during the intervention
Time frame: 4 weeks
Difference in plasma metabolites (blood obtained fastened state) depending on the protein supplementation amount. Targeted and untargeted metabolomics measurements will be used (e.g., lipids, and polar and non polar metabolomics). Plasma 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.
Profile/composition of the gut microbiota during the intervention
Time frame: 8 weeks
Difference in the gut microbiota profile/composition because of the protein supplementation and from colonic in vitro fermentation will be assessed by 16s/NGS. Alpha and Beta diversity will be measured and compared throughout the 4 weeks of intervention and baselines. In the case of NGS, the genome sequence will be annotated and the resulting set of genes encoding for metabolic enzymes will be extracted. Data from shotgun metagenomics and metabolomics will be integrated by constructing dependency networks, with a special attempt to infer causal relationships among different variables.
Routinely analysed markers for protein intake/compliance during the intervention - urine
Time frame: 4 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 during the intervention - blood
Time frame: 4 weeks
Difference in blood (serum) samples markers due to the protein supplementation (e.g., urea and creatinine)
Changes in the plasma metabolites using targeted and untargeted metabolomics during the dietary challenge
Time frame: 4 weeks
Difference in plasma metabolites depending on the protein taken as breaskfast. Targeted and untargeted metabolomics measurements will be used (e.g., polar and non polar metabolomics). Plasma 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 with those found in the fastening state.
Colonic in vitro fermentation
Time frame: 4 weeks
Subjects will have their fresh faecal samples used in the colonic in vitro fermentation experiment to evaluate whether and how gut metabolites production can be predicted in vitro. The same proteins used in the dietary intervention study will be digested in vitro and used for the batch in vitro colonic fermentation. Supernatant will be used for metabolomics analysis (outcome 1) and selected fermentation time point pellets will be used for microbiota composition and functional analyses (outcome 3).
18 secondary outcomes
Food intake using food diaries
Time frame: 8 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: 4 weeks
Assessment of body weight during the study
Time frame: 4 weeks
Assessment of body composition
Time frame: 4 weeks
Concentrations of faecal calprotectin
Time frame: 4 weeks
Fasting blood glucose level
Time frame: 4 weeks
Fasting blood insulin level
Time frame: 4 weeks
Fasting blood C-reactive protein level
Time frame: 4 weeks
Fasting blood cholesterol (total, LDL, and HDL) level
Time frame: 4 weeks
Fasting blood triglycerides level
Time frame: 4 weeks
Concentration of glucose - dietary challenge
Time frame: 4 weeks
Concentration of insulin - dietary challenge
Time frame: 4 weeks
Profile/composition of the gut microbiota after the intervention
Time frame: 2 weeks
Changes in the faecal metabolites using targeted and untargeted metabolomics after the intervention
Time frame: 2 weeks
Breath test
Time frame: 4 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 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 Protein supplementation 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 during the intervention (time frame: 8 weeks). The study lists 7 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.