Postprandial HyperglycemiaCOBRANCT06253728
A Study of Biochemical Response to Alternative Proteins
A study testing High fiber and protein meal in people with Postprandial Hyperglycemia and Overweight and Obesity, run by University of Eastern Finland at 1 site in Finland.
Trial summary
The overall objective of this research is to determine the digestive faith and health impact of protein and fiber rich foods in different food matrices in type 2 diabetes risk population. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Postprandial Hyperglycemia, Overweight and Obesity, Type2diabetes
- What is being tested?
- High fiber and protein meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFinland
- Study dates
- 18 Jan 2024to 31 Dec 2025
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30-65 years of age
- BMI >25 kg/m2 and <35 kg/m2
- Waist circumference with females >85 cm and with males >100 cm
Who cannot join
- Certain chronic diseases requiring regular medication (e.g., type 2 diabetes, chronic liver, kidney, thyroid, or gastrointestinal diseases)
- Pregnancy or breastfeeding
- Gluten-free or vegan diet
- Use of antibiotics within the last 12 months
- Gastrointestinal surgery within the last two years
- High alcohol consumption
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
University of Eastern Finland
Kuopio, 70211
Moona Partanen, +358440101198, moona.partanen@uef.fi
Marjukka Kolehmainen, 0403553617, marjukka.kolehmainen@uef.fi
About this study
Official title: Comprehensive Study of Biochemical Response to Alternative Protein Sources in Different Food Matrices
The overall objective of this research is to determine the digestive faith and health impact of protein and fiber rich foods in different food matrices in type 2 diabetes risk population. This is achieved by controlled postprandial intervention where plasma amino acids, lipids, glucose metabolism, bile acids and microbial metabolites are evaluated as well as fecal microbiota and metabolites.
Read the detailed description
Detailed research aim of this controlled, randomized crossover postprandial clinical study are:
- To study the impact of complex plant- and animal-based foods on glucose metabolism, acute inflammation, and markers of microbial fermentation of fiber and proteins.
- To investigate the difference in the gut mediated metabolism induced by naturally occurring fiber fraction bound plant protein or by plant protein with added fiber when compared to animal protein.
- To conduct in vitro experiments using fecal samples from participants in the meal study to investigate the distinctions between different animal and plant proteins on both host and microbial metabolites, as well as the function of the gut barrier.
- Being tested
- High fiber and protein meal, Control
- Medical subject headings
- Hyperglycemia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fiber and protein mealDietary supplement
In the intervention participants are assigned to eat high protein and fiber meal that differ in protein source or structure.
ControlDietary supplement
The control meal is low fiber and low protein meal.
| Study group | Role | What they receive |
|---|---|---|
| Meal 1 | Experimental | Meal with plant protein and fiber in an intact structure Receives: Dietary Supplement: High fiber and protein meal |
| Meal 2 | Experimental | Meal with plant protein and fiber, where the cell structure is broken Receives: Dietary Supplement: High fiber and protein meal |
| Meal 3 | Placebo comparator | Low protein and low fiber cereal Receives: Dietary Supplement: Control |
| Meal 4 | Experimental | High protein and low carbohydrate bread with animal proteins Receives: Dietary Supplement: High fiber and protein meal |
| Meal 5 | Experimental | High protein and low carbohydrate bread with plant protein Receives: Dietary Supplement: High fiber and protein meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acids
Plasma free amino acids were measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Measured: 0-4 hours
Gut derived metabolites
Gut derived metabolites are measured with untargeted metabolomics from plasma at 12 hours after consuming the study meal. From fecal sample, the metabolomics are measured at 24 hours after consuming the study meal. Plasma short chain fatty acids are quantified at 12 hours after consuming the study meal.
Measured: 0-24 hours
Secondary outcomes (6)
Plasma glucose
Plasma glucose is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Measured: 0-4 hours
Inflammation marker
Plasma IL-22 is measured at 0, 60, 240 minutes after consuming the study meal.
Measured: 0-4 hours
Plasma triglycerides
Plasma triglycerides are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Measured: 0-4 hours
Urine para-cresol
The amount of para-cresol is measured from urine sample at 24 hours after consuming the study meal.
Measured: 24 hours
Plasma insulin
Plasma insulin is measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Measured: 0-4 hours
Plasma free fatty acids
Plasma free fatty acids are measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Measured: 0-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start18 Jan 2024
- Primary completion3 Jun 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjukka Kolehmainen, Professor, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253728
- Sponsor's protocol ID
- A80406
- Acronym
- COBRA
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Study of Biochemical Response to Alternative Protein Sources in Different Food Matrices
- ClinicalTrials.gov ID
- NCT06253728
- Acronym / sponsor ID
- COBRA / A80406
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 3 Jun 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Feb 2024 (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 objective of this research is to determine the digestive faith and health impact of protein and fiber rich foods in different food matrices in type 2 diabetes risk population. This is achieved by controlled postprandial intervention where plasma amino acids, lipids, glucose metabolism, bile acids and microbial metabolites are evaluated as well as fecal microbiota and metabolites.
Detailed description
Detailed research aim of this controlled, randomized crossover postprandial clinical study are:
- To study the impact of complex plant- and animal-based foods on glucose metabolism, acute inflammation, and markers of microbial fermentation of fiber and proteins.
- To investigate the difference in the gut mediated metabolism induced by naturally occurring fiber fraction bound plant protein or by plant protein with added fiber when compared to animal protein.
- To conduct in vitro experiments using fecal samples from participants in the meal study to investigate the distinctions between different animal and plant proteins on both host and microbial metabolites, as well as the function of the gut barrier.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Meal 1 | Experimental | Dietary Supplement: High fiber and protein mealMeal with plant protein and fiber in an intact structure |
| Meal 2 | Experimental | Dietary Supplement: High fiber and protein mealMeal with plant protein and fiber, where the cell structure is broken |
| Meal 3 | Placebo comparator | Dietary Supplement: ControlLow protein and low fiber cereal |
| Meal 4 | Experimental | Dietary Supplement: High fiber and protein mealHigh protein and low carbohydrate bread with animal proteins |
| Meal 5 | Experimental | Dietary Supplement: High fiber and protein mealHigh protein and low carbohydrate bread with plant protein |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 30-65 years of age
- BMI >25 kg/m2 and <35 kg/m2
- Waist circumference with females >85 cm and with males >100 cm
Key exclusion criteria (6 listed)
- Certain chronic diseases requiring regular medication (e.g., type 2 diabetes, chronic liver, kidney, thyroid, or gastrointestinal diseases)
- Pregnancy or breastfeeding
- Gluten-free or vegan diet
- Use of antibiotics within the last 12 months
- Gastrointestinal surgery within the last two years
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 |
|---|---|---|
| High fiber and protein mealIn the intervention participants are assigned to eat high protein and fiber meal that differ in protein source or structure. | Dietary supplement | Meal 1, Meal 2, Meal 4, Meal 5 |
| ControlThe control meal is low fiber and low protein meal. | Dietary supplement | Meal 3 |
Primary outcome
Plasma amino acids
Time frame: 0-4 hours
Plasma free amino acids were measured at 0, 30, 60, 90, 180, and 240 minutes after consuming the study meal.
Gut derived metabolites
Time frame: 0-24 hours
Gut derived metabolites are measured with untargeted metabolomics from plasma at 12 hours after consuming the study meal. From fecal sample, the metabolomics are measured at 24 hours after consuming the study meal. Plasma short chain fatty acids are quantified at 12 hours after consuming the study meal.
6 secondary outcomes
Plasma glucose
Time frame: 0-4 hours
Inflammation marker
Time frame: 0-4 hours
Plasma triglycerides
Time frame: 0-4 hours
Urine para-cresol
Time frame: 24 hours
Plasma insulin
Time frame: 0-4 hours
Plasma free fatty acids
Time frame: 0-4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Marjukka Kolehmainen, Professor principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fiber and protein meal in people with Postprandial Hyperglycemia and Overweight and Obesity, run by University of Eastern Finland at 1 site in Finland.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. 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 Finland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marjukka Kolehmainen, Professor (0403553617, marjukka.kolehmainen@uef.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma amino acids (time frame: 0-4 hours). The study lists 2 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 12 Feb 2024.