High Blood Pressure, High Cholesterol/Hyperlipidemia, Overweight and Obesity
Conditions
Brief 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. 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: 1. Compare effect of oat and rice rich diets to blood lipid and glucose status, perceived gut and general well-being and dietary intake. 2. Investigate changes in fecal microbiome, SCFAs, plasma antioxidant status and inflammation markers resulting from consumption of oat or rice rich low-gluten diets. 3. 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. 4. 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. 5. 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).
Interventions
OTHERDietary intervention
Changes in dietary intake, metabolism, fecal microbiome, vitality and perceived health after a 6-week consumption of oat or rice-rich low-gluten diet.
OTHERPostprandial meal test
Postprandial changes after the 6-week consumption of either oat or rice-rich low-gluten diet, including blood markers, microbiome, satiety, recovery and vitality.
Sponsors
University of Turku
University of Eastern Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from Baseline in Serum Total Cholesterol | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from Baseline in Blood Lipids | Week 0 and Week 6 | Cholesterols (HDL, LDL), Triglycerides and Free fatty acids (FFA) are measured from fasting blood samples before and after the 6-week dietary intervention. |
| Changes from Baseline in Glucose Metabolism | Week 0 and Week 6 | Glucose and insulin are measured from fasting blood samples before and after the 6-week dietary intervention. |
| Changes in Postprandial Glucose metabolism | 0, 15, 30, 45, 60, 90, 120, 180 minutes after the study meal at week 0 and week 6 | 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). |
| Changes from Baseline in Inflammation markers | Week 0 and Week 6 | 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). |
| Changes from Baseline in Plasma metabolome | Week 0 and Week 6 | Circulating metabolites are measured from fasting plasma samples before and after the 6-week dietary intervention. |
| Changes from Baseline in Plasma Tryptophan Metabolites | Week 0 and Week 6 | 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. |
| Changes from Baseline in plasma Short-Chain Fatty Acids | Week 0 and Week 6 | 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. |
| Changes in Postprandial status of Peptide-YY (PYY) concentrations | 0, 15, 30, 45, 60, 90, 120, 180 minutes after the study meal at week 0 and week 6 | 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). |
| Changes from Baseline in Plasma Antioxidant Capacity | Week 0 and Week 6 | 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. |
| Changes from Baseline in Fecal Microbiome | Week 0 and Week 6 | 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. |
| Changes from Baseline in Blood Pressure | Week 0 and Week 6 | 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). |
| Changes from baseline in Anthropometric measurements | Weeks 0 and 6 | 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. |
| Changes from baseline in Dietary intake and Diet quality | Week 0 and Week 6; FFQ on Week 0, 3 and 6 | 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). |
| Changes from Baseline in Bowel movement frequency and Stool types | Week 0 and Week 6 | 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). |
| Changes from baseline in Gastrointestinal symptoms by GSRS | Weeks 0 and Week 6 | 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. |
| Changes from baseline in Perceived well-being by RAND-36 | Weeks 0 and Week 6 | 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. |
| Changes in Neuropsychological Performance: Cognitive Load | 0 and 60 minutes after the study meal at week 0 and week 6 | 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. |
| Changes in Neuropsychological Performance: Reaction Time and Attention | 0 and 60 minutes after the study meal at week 0 and week 6 | 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. |
| Changes in Neuropsychological Performance: Response Control | 0 and 60 minutes after the study meal at week 0 and week 6 | 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. |
Countries
Finland
Outcome results
None listed