High Cholesterol/HyperlipidemiaNCT05526092
OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals
A study testing Dietary intervention and Postprandial meal test in people with High Cholesterol/Hyperlipidemia and High Blood Pressure, run by University of Turku at 2 sites in Finland.
Trial summary
The overall objective of this research entity is to reveal the comprehensive health impact of oats in metabolically challenged individuals in a 6-week intervention, compared to that of rice. Read more about this study
- Who is it for?
- Ages 30 to 68 years
- Conditions the study is for
- High Cholesterol/Hyperlipidemia, High Blood Pressure, Overweight and Obesity
- What is being tested?
- Dietary intervention and Postprandial meal test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesFinland
- Study dates
- 12 Sep 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Commits to follow the instructed low-gluten diet for 6 weeks
- 30 - 68 years of age
- BMI > 25 kg/m^2
- High cholesterol (without medication) characterized as total cholesterol > 5 mmol/l, AND either LDL > 3 mmol/l OR HDL (men/women) < 1.0/1.2 mmol/l AND/OR Hypertension (systolic > 140 mmHg or diastolic > 90 mmHg).
Who cannot join
- Regular medication that can affect the research outcomes (balanced medication for hypertension, hypo-/hyperthyroidism, hormone replacement therapy, and inhaled medicines allowed)
- Pregnancy or lactation
- Heavy smoking
- Recent course of antibiotics (less than 3 months prior to the study)
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Institute of Public Health and Clinical Nutrition, University of Eastern Finland
Kuopio, 70211
Food Sciences, Department of Life Technologies, University of Turku
Turku, Turku, 20500
About this study
Official title: OAT-GUT-BRAIN: Comprehensive Health Effects of Long-term Consumption of Oats in Metabolically Challenged Volunteers - Gut-mediated Metabolomics and Vitality
The overall objective of this research entity is to reveal the comprehensive health impact of oats in metabolically challenged individuals in a 6-week intervention, compared to that of rice. This is achieved by investigation of the lipids, short-chain fatty acids, inflammation markers and antioxidant status from plasma, fecal microbiome, and plasma metabolome. Additionally the effect of the 6-week diet on postprandial glycemia and postprandial satiety and vitality are investigated.
Read the detailed description
Aims in this 6-week randomised, single-blinded clinical trial, including a postprandial study, with metabolically challenged volunteers on oat-rich low-gluten diet, are to:
- Compare effect of oat and rice rich diets to blood lipid and glucose status, perceived gut and general well-being and dietary intake.
- Investigate changes in fecal microbiome, SCFAs, plasma antioxidant status and inflammation markers resulting from consumption of oat or rice rich low-gluten diets.
- Examine the impact of the oat or rice-rich low-gluten diet on the change in metabolite profiles in blood by non-targeted metabolomics approach.
- Find out the long-term effects of oat and rice consumption on recovery and vitality by modulating the gut-brain axis and measured with neuropsychological testing and using tryptophan metabolites as biomarkers.
- Discover how the long-term consumption of oats and rice and their possible alterations in fecal microbiome affect subsequent postprandial glycaemia and response of microbiota to the meal (as seen in plasma SCFAs).
- Being tested
- Dietary intervention, Postprandial meal test
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias, Hypertension, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Changes in dietary intake, metabolism, fecal microbiome, vitality and perceived health after a 6-week consumption of oat or rice-rich low-gluten diet.
Postprandial meal testOther
Postprandial changes after the 6-week consumption of either oat or rice-rich low-gluten diet, including blood markers, microbiome, satiety, recovery and vitality.
| Study group | Role | What they receive |
|---|---|---|
| Oat-rich and low-gluten diet with oat-rich meal test | Experimental | Participants will consume oats as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served an oat-rich breakfast. Receives: Other: Dietary intervention; Other: Postprandial meal test |
| Rice-rich low-gluten diet with oat-rich meal test | Active comparator | Participants will consume rice as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served an oat-rich breakfast. Receives: Other: Dietary intervention; Other: Postprandial meal test |
| Oat-rich low-gluten diet with rice-rich meal test | Experimental | Participants will consume oats as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served a rice-rich breakfast. Receives: Other: Dietary intervention; Other: Postprandial meal test |
| Rice-rich low-gluten diet with rice-rich meal test | Active comparator | Participants will consume rice as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served a rice-rich breakfast. Receives: Other: Dietary intervention; Other: Postprandial meal test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in Serum Total Cholesterol
Serum total cholesterol will be measured from fasting blood samples at the baseline (week 0) and after 6 week of the dietary intervention (week 6).
Measured: Week 0 and Week 6
Changes from Baseline in Interleukin-10
Interleukin-10 is measured from fasting plasma samples at the baseline (week 0) and after the 6-week diet intervention (week 6). It will be analysed as part of the Olink Target 48 Cytokine Panel (Olink Proteomics, Uppsala, Sweden) that provides absolute quantities for 45 different proteins, such as interleukins, interferons, chemokines and growth factors that are related to inflammation.
Measured: Week 0 and Week 6
Secondary outcomes (19)
Changes from Baseline in Blood Lipids
Cholesterols (HDL, LDL), Triglycerides and Free fatty acids (FFA) are measured from fasting blood samples before and after the 6-week dietary intervention.
Measured: Week 0 and Week 6
Changes from Baseline in Glucose Metabolism
Glucose and insulin are measured from fasting blood samples before and after the 6-week dietary intervention.
Measured: Week 0 and Week 6
Changes in Postprandial Glucose metabolism
Glucose and insulin in blood is measured during 3 hours (8 time points) after consumption of the study meal (including the fasted state at 0 min). The changed postprandial status is studied at the baseline (week 0) and after the 6-week diet intervention (week 6).
Measured: 0, 15, 30, 45, 60, 90, 120, 180 minutes after the study meal at week 0 and week 6
Changes from Baseline in Inflammation markers
Inflammation markers of 45 different proteins, such as interleukins, interferons, chemokines and growth factors are measured from fasting plasma samples at the baseline before and after the 6-week diet intervention. The absolute quantities of the markers will be analysed with Olink Target 48 Cytokine Panel (Olink Proteomics, Uppsala, Sweden).
Measured: Week 0 and Week 6
Changes from Baseline in Plasma metabolome
Circulating metabolites are measured from fasting plasma samples before and after the 6-week dietary intervention.
Measured: Week 0 and Week 6
Changes from Baseline in Plasma Tryptophan Metabolites
Circulating tryptophan metabolites are measured from fasting plasma samples before and after the 6-week dietary intervention to study modulation of the gut-brain-axis.
Measured: Week 0 and Week 6
Changes from Baseline in plasma Short-Chain Fatty Acids
Blood samples are taken at the fasting state before and after the 6-week diet intervention. Plasma is analysed by using UHPLC-MS to see the changes in plasma SCFA concentrations.
Measured: Week 0 and Week 6
Changes in Postprandial status of Peptide-YY (PYY) concentrations
PYY concentrations in blood are measured during 3 hours (8 time points) after consumption of the study meal (including the fasted state at 0 min). The changed postprandial status is studied at the baseline (week 0) and after the 6-week diet intervention (week 6).
Measured: 0, 15, 30, 45, 60, 90, 120, 180 minutes after the study meal at week 0 and week 6
Changes from Baseline in Plasma Antioxidant Capacity
The antioxidant status of plasma will be analysed with commercial kits of Ferric Reducing Antioxidant Power (FRAP) and Oxygen Radical Absorbance Capacity (ORAC) from fasting blood samples before and after the 6-week dietary intervention.
Measured: Week 0 and Week 6
Changes from Baseline in Fecal Microbiome
Stool samples are collected from the participants at the baseline (week 0) and after the 6-week diet intervention (week 6), and the metagenome is sequenced from the extracted DNA by shotgun metagenomics by Novogene GmbH (Munich, Germany). Changes in fecal microbiome during the dietary intervention are investigated by changes in alpha and beta diversities, taxonomy and metabolical pathways.
Measured: Week 0 and Week 6
Changes from Baseline in Blood Pressure
Blood pressure (systolic and diastolic) is measured twice, with a 1-min break between measurements at the baseline (week 0) and after the 6-week diet intervention (week 6).
Measured: Week 0 and Week 6
Changes from baseline in Anthropometric measurements
Weight (kg), height (cm), and waist circumference (cm) are measured after an overnight fast at the baseline (week 0) and after the 6-week diet intervention (week 6). BMI is calculated from the measured results.
Measured: Weeks 0 and 6
Changes from baseline in Dietary intake and Diet quality
Food records are collected from three consecutive weekdays and one weekend day at the baseline (week 0) and after the 6-week diet intervention (week 6). AivoDiet software (AivoDiet 2.2.0.0, Mashie, Malmö, Sweden) is used to calculate nutrient intake from the 4-day food records.
Diet quality is measured through validated Food Frequency Questionnaire (FFQ) by Leppälä et al. (2010, doi: 10.1177/1403494810382476) including questions regarding oat and rice intakes to evaluate compliance to the study diet. FFQ is collected at the baseline, after 3 weeks of the diet and in the end of the intervention (week 6).
Measured: Week 0 and Week 6; FFQ on Week 0, 3 and 6
Changes from Baseline in Bowel movement frequency and Stool types
The changes in bowel movement frequency and stool consistency are recorded using a defecation record with the 7-step Bristol stool chart for the same 4 days as the food record. Participant will record the time of the bowel movement and the dominant type of the stool. The Bristol types will be categorized as hard (types 1 and 2), normal (types 3, 4, and 5), or loose stools (types 6 and 7).
Measured: Week 0 and Week 6
Changes from baseline in Gastrointestinal symptoms by GSRS
Gastrointestinal symptoms (self-reported) are measured by a Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire at the baseline (week 0) and after the 6-week diet intervention (week 6). The GSRS results are rated according to the severity of a symptom and divided into subcategories of stomachache, bloating, flatulence, constipation, and diarrhea in addition to the total score. A higher score refers to more symptoms.
Measured: Weeks 0 and Week 6
Changes from baseline in Perceived well-being by RAND-36
Perceived well-being (self-reported) is measured by a RAND-36 questionnaire, derived from the Short Form-36 Health Survey (SF-36) at the baseline (week 0) and after the 6-week diet intervention (week 6). The RAND-36 answers are rated according to the instructions for indices that are then divided into scales of physical and social functionality, role limitations caused by physical and emotional health problems, bodily pain, general health perception, vitality, and mental health in addition to the total score. A higher score refers to better perceived health.
Measured: Weeks 0 and Week 6
Changes in Neuropsychological Performance: Cognitive Load
Established and well-validated computerised neuropsychological tests to measure cognitive load will be conducted both at the beginning and at the end of the intervention in connection with postprandial test. Inquisit software (Millisecond Software, Seattle, Washington, USA; https://www.millisecond.com/download/library/) is used for the cognitive load (Serial Sevens Task) test.
Measured: 0 and 60 minutes after the study meal at week 0 and week 6
Changes in Neuropsychological Performance: Reaction Time and Attention
Established and well-validated computerised neuropsychological tests to measure reaction time and attention will be conducted both at the beginning and at the end of the intervention in connection with postprandial test. Inquisit software (Millisecond Software, Seattle, Washington, USA; https://www.millisecond.com/download/library/) is used for the reaction time and attention (Color Word Stroop test) test.
Measured: 0 and 60 minutes after the study meal at week 0 and week 6
Changes in Neuropsychological Performance: Response Control
Established and well-validated computerised neuropsychological tests to measure response control will be conducted both at the beginning and at the end of the intervention in connection with postprandial test. Inquisit software (Millisecond Software, Seattle, Washington, USA; https://www.millisecond.com/download/library/) is used for the response control (Cued Go/No-Go Task) test.
Measured: 0 and 60 minutes after the study meal at week 0 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start12 Sep 2022
- Primary completion31 Dec 2023
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for High Cholesterol/HyperlipidemiaStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Principal investigator, Kaisa Linderborg, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526092
- Sponsor's protocol ID
- OGB
- Status last verified
- Mar 2026
- First submitted
- 26 Aug 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sensitive volunteer data may only be shared for collaborative research purposes with a separate agreement with the data owner. Metagenomic sequencing data can be found with identifier PRJEB104478 from ENA.
Publications
Mannila E, Nuotio P, Kuosmanen A, De Storvik S, Karlund A, Jukkara A, Tauriainen MM, Narvainen J, Kolehmainen M, Linderborg KM. Comparison of Low-Gluten Diets Rich in Oats or Rice-A 6-Week Randomized Clinical Trial With Metabolically Challenged Volunteers. Mol Nutr Food Res. 2025 Jun;69(12):e70076. doi: 10.1002/mnfr.70076. Epub 2025 May 7.
PubMed 40331457Mannila E, Gomez-Gallego C, Muluh G, Nuotio P, Koistinen V, Erawijantari PP, Salminen S, Lahti L, Kolehmainen M, Linderborg KM. Oat-Rich Low-Gluten Diet Modulates Plasma Short-Chain Fatty Acids without Significant Changes in Fecal Microbiome or Inflammatory Markers-A Randomized Clinical Trial in People with Cardiometabolic Risk. J Nutr. 2026 Jun 30;156(9):101690. doi: 10.1016/j.tjnut.2026.101690. Online ahead of print.
PubMed 42379395
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OAT-GUT-BRAIN: Comprehensive Health Effects of Long-term Consumption of Oats in Metabolically Challenged Volunteers - Gut-mediated Metabolomics and Vitality
- ClinicalTrials.gov ID
- NCT05526092
- Acronym / sponsor ID
- OGB
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Sep 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 objective of this research entity is to reveal the comprehensive health impact of oats in metabolically challenged individuals in a 6-week intervention, compared to that of rice. This is achieved by investigation of the lipids, short-chain fatty acids, inflammation markers and antioxidant status from plasma, fecal microbiome, and plasma metabolome. Additionally the effect of the 6-week diet on postprandial glycemia and postprandial satiety and vitality are investigated.
Detailed description
Aims in this 6-week randomised, single-blinded clinical trial, including a postprandial study, with metabolically challenged volunteers on oat-rich low-gluten diet, are to:
- Compare effect of oat and rice rich diets to blood lipid and glucose status, perceived gut and general well-being and dietary intake.
- Investigate changes in fecal microbiome, SCFAs, plasma antioxidant status and inflammation markers resulting from consumption of oat or rice rich low-gluten diets.
- Examine the impact of the oat or rice-rich low-gluten diet on the change in metabolite profiles in blood by non-targeted metabolomics approach.
- Find out the long-term effects of oat and rice consumption on recovery and vitality by modulating the gut-brain axis and measured with neuropsychological testing and using tryptophan metabolites as biomarkers.
- Discover how the long-term consumption of oats and rice and their possible alterations in fecal microbiome affect subsequent postprandial glycaemia and response of microbiota to the meal (as seen in plasma SCFAs).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oat-rich and low-gluten diet with oat-rich meal test | Experimental | Other: Dietary intervention, Other: Postprandial meal testParticipants will consume oats as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served an oat-rich breakfast. |
| Rice-rich low-gluten diet with oat-rich meal test | Active comparator | Other: Dietary intervention, Other: Postprandial meal testParticipants will consume rice as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served an oat-rich breakfast. |
| Oat-rich low-gluten diet with rice-rich meal test | Experimental | Other: Dietary intervention, Other: Postprandial meal testParticipants will consume oats as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served a rice-rich breakfast. |
| Rice-rich low-gluten diet with rice-rich meal test | Active comparator | Other: Dietary intervention, Other: Postprandial meal testParticipants will consume rice as the main cereal in their diet and follow low-gluten diet for 6 weeks. In postprandial meal test, they will be served a rice-rich breakfast. |
Who may qualify
- Ages
- 30 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Commits to follow the instructed low-gluten diet for 6 weeks
- 30 - 68 years of age
- BMI > 25 kg/m^2
- High cholesterol (without medication) characterized as total cholesterol > 5 mmol/l, AND either LDL > 3 mmol/l OR HDL (men/women) < 1.0/1.2 mmol/l AND/OR Hypertension (systolic > 140 mmHg or diastolic > 90 mmHg).
Key exclusion criteria (4 listed)
- Regular medication that can affect the research outcomes (balanced medication for hypertension, hypo-/hyperthyroidism, hormone replacement therapy, and inhaled medicines allowed)
- Pregnancy or lactation
- Heavy smoking
- Recent course of antibiotics (less than 3 months prior to the study)
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 |
|---|---|---|
| Dietary interventionChanges in dietary intake, metabolism, fecal microbiome, vitality and perceived health after a 6-week consumption of oat or rice-rich low-gluten diet. | Other | Oat-rich and low-gluten diet with oat-rich meal test, Oat-rich low-gluten diet with rice-rich meal test, Rice-rich low-gluten diet with oat-rich meal test, Rice-rich low-gluten diet with rice-rich meal test |
| Postprandial meal testPostprandial changes after the 6-week consumption of either oat or rice-rich low-gluten diet, including blood markers, microbiome, satiety, recovery and vitality. | Other | Oat-rich and low-gluten diet with oat-rich meal test, Oat-rich low-gluten diet with rice-rich meal test, Rice-rich low-gluten diet with oat-rich meal test, Rice-rich low-gluten diet with rice-rich meal test |
Primary outcome
Changes from Baseline in Serum Total Cholesterol
Time frame: Week 0 and Week 6
Serum total cholesterol will be measured from fasting blood samples at the baseline (week 0) and after 6 week of the dietary intervention (week 6).
Changes from Baseline in Interleukin-10
Time frame: Week 0 and Week 6
Interleukin-10 is measured from fasting plasma samples at the baseline (week 0) and after the 6-week diet intervention (week 6). It will be analysed as part of the Olink Target 48 Cytokine Panel (Olink Proteomics, Uppsala, Sweden) that provides absolute quantities for 45 different proteins, such as interleukins, interferons, chemokines and growth factors that are related to inflammation.
19 secondary outcomes
Changes from Baseline in Blood Lipids
Time frame: Week 0 and Week 6
Changes from Baseline in Glucose Metabolism
Time frame: Week 0 and Week 6
Changes in Postprandial Glucose metabolism
Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes after the study meal at week 0 and week 6
Changes from Baseline in Inflammation markers
Time frame: Week 0 and Week 6
Changes from Baseline in Plasma metabolome
Time frame: Week 0 and Week 6
Changes from Baseline in Plasma Tryptophan Metabolites
Time frame: Week 0 and Week 6
Changes from Baseline in plasma Short-Chain Fatty Acids
Time frame: Week 0 and Week 6
Changes in Postprandial status of Peptide-YY (PYY) concentrations
Time frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes after the study meal at week 0 and week 6
Changes from Baseline in Plasma Antioxidant Capacity
Time frame: Week 0 and Week 6
Changes from Baseline in Fecal Microbiome
Time frame: Week 0 and Week 6
Changes from Baseline in Blood Pressure
Time frame: Week 0 and Week 6
Changes from baseline in Anthropometric measurements
Time frame: Weeks 0 and 6
Changes from baseline in Dietary intake and Diet quality
Time frame: Week 0 and Week 6; FFQ on Week 0, 3 and 6
Changes from Baseline in Bowel movement frequency and Stool types
Time frame: Week 0 and Week 6
Changes from baseline in Gastrointestinal symptoms by GSRS
Time frame: Weeks 0 and Week 6
Changes from baseline in Perceived well-being by RAND-36
Time frame: Weeks 0 and Week 6
Changes in Neuropsychological Performance: Cognitive Load
Time frame: 0 and 60 minutes after the study meal at week 0 and week 6
Changes in Neuropsychological Performance: Reaction Time and Attention
Time frame: 0 and 60 minutes after the study meal at week 0 and week 6
Changes in Neuropsychological Performance: Response Control
Time frame: 0 and 60 minutes after the study meal at week 0 and week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Results publication: PubMed 40331457Mannila E, Nuotio P, Kuosmanen A, De Storvik S, Karlund A, Jukkara A, Tauriainen MM, Narvainen J, Kolehmainen M, Linderborg KM. Comparison of Low-Gluten Diets Rich in Oats or Rice-A 6-Week Randomized Clinical Trial With Metabolically Challenged Volunteers. Mol Nutr Food Res. 2025 Jun;69(12):e70076. doi: 10.1002/mnfr.70076. Epub 2025 May 7.
- Derived from this study: PubMed 42379395Mannila E, Gomez-Gallego C, Muluh G, Nuotio P, Koistinen V, Erawijantari PP, Salminen S, Lahti L, Kolehmainen M, Linderborg KM. Oat-Rich Low-Gluten Diet Modulates Plasma Short-Chain Fatty Acids without Significant Changes in Fecal Microbiome or Inflammatory Markers-A Randomized Clinical Trial in People with Cardiometabolic Risk. J Nutr. 2026 Jun 30;156(9):101690. doi: 10.1016/j.tjnut.2026.101690. Online ahead of print.
- Home page of the study, in FinnishLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Sensitive volunteer data may only be shared for collaborative research purposes with a separate agreement with the data owner. Metagenomic sequencing data can be found with identifier PRJEB104478 from ENA.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention and Postprandial meal test in people with High Cholesterol/Hyperlipidemia and High Blood Pressure, run by University of Turku at 2 sites 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
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 from Baseline in Serum Total Cholesterol (time frame: Week 0 and Week 6). 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?
On the ClinicalTrials.gov record for NCT05526092, which also lists 2 linked publications.
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 13 Apr 2026.