Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Eastern Finland | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention | Other | Changes in dietary intake, metabolism, fecal microbiome, vitality and perceived health after a 6-week consumption of oat or rice-rich low-gluten diet. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Week 0 and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0 and Week 6 |
| Changes from Baseline in Glucose Metabolism |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in postprandial status of inflammation markers | Inflammation markers of 45 different proteins, such as interleukins, interferons, chemokines and growth factors 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). The absolute quantities of the markers will be analysed with Olink Target 48 Cytokine Panel (Olink Proteomics, Uppsala, Sweden). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Food Sciences, Department of Life Technologies, University of Turku | Turku | Turku | 20500 | Finland | ||
| Institute of Public Health and Clinical Nutrition, University of Eastern Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40331457 | Result | 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. | |
| 42379395 |
| Label | URL |
|---|---|
| Home page of the study, in Finnish | View source |
Not provided
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.
IPD will be available once the primary publications are published.
Only for collaborative research purposes with a separate agreement with the data owner, the accessibility of data and documents can be decided together.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Postprandial meal test | Other | Postprandial changes after the 6-week consumption of either oat or rice-rich low-gluten diet, including blood markers, microbiome, satiety, recovery and vitality. |
|
Glucose and insulin are measured from fasting blood samples before and after the 6-week dietary intervention. |
| 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). | 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). | 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. | 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. | 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. | 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). | 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. | 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. | 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). | 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. | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 0 and 60 minutes after the study meal at week 0 and week 6 |
| 0, 15, 30, 45, 60, 90, 120, 180 minutes after the study meal at week 0 and week 6 |
| Changes postprandial status of Plasma Short-Chain Fatty Acids | SCFAs in blood are measured during 3 hours (3 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). | 0, 90, 180 minutes after the study meal at week 0 and week 6 |
| Changes in postprandial status of Plasma metabolome | Circulating metabolites 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). | 0, 15, 30, 45, 60, 90, 120, 180 minutes after the study meal at week 0 and week 6 |
| Changes in postprandial status of Plasma Antioxidant Capacity | The antioxidant capacity of plasma 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). Commercial kits of Ferric Reducing Antioxidant Power (FRAP) and Oxygen Radical Absorbance Capacity (ORAC) will be used. | 0, 15, 30, 45, 60, 90, 120, 180 minutes after the study meal at week 0 and week 6 |
| Changes from Baseline in Satiety | Satiety related sensations are evaluated before and right after consuming the test meal and repetitively during 3 hours for 8 time points after the starting point of the consumption using 10 cm visual analogue scales (VAS) anchored with extremes (0 = not at all, 10 = extremely). The evaluated sensations are hunger, fullness, satiety, and desire to eat. The changed postprandial status is studied at the baseline (week 0) and after the 6-week diet intervention (week 6). | 0, 15, 30, 45, 60, 90, 120, 180 minutes after the study meal at week 0 and week 6 |
| Changes from Baseline in Heart Rate Variability (HRV) | HRV is measured with Bittium Faros ECG Sensor that is attached with three electrodes to approx. 2 cm below the clavicles, about halfway of the bone horizontally (2 electrodes), as well as to the left at the bottom of the rib arch, approximately in the same vertical line with the upper electrode. HRV is measured through the full study day during the postprandial meal test and neuropsychological tests. The changed HRV is studied at the baseline (week 0) and after the 6-week diet intervention (week 6). | 3,5 hours during the study day on Week 0 and Week 6 |
| Changes from Baseline in Bile acids | Stool samples are collected from the participants at the baseline (week 0) and after the 6-week diet intervention (week 6), and the changes in fecal bile acids during the dietary intervention are investigated. | Week 0 and Week 6 |
| Kuopio |
| 70211 |
| Finland |
| Mannila E, Gomez-Gallego C, Muluh G, Nuotio P, Koistinen V, Erawijantari P, 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 30:101690. doi: 10.1016/j.tjnut.2026.101690. Online ahead of print. |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| D006973 | Hypertension |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
Not provided
Not provided