Personalized dietary advice based on metabolic responses
The NUTRIOME Meal Study - a Data-driven Precision Nutrition Intervention Study Using Meal Responses
This study is testing whether personalized diet plans based on how your body reacts to food can improve heart and metabolic health better than a standard healthy diet for people aged 40 to 70 who are slightly overweight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Chalmers University of Technology Academic / other |
| Locations | 3 sites (Wageningen and 2 other locations) |
| Trial ID | NCT06842433 on ClinicalTrials.gov |
What this trial studies
This multi-center study aims to develop personalized dietary recommendations by analyzing metabolic responses to various dietary challenges. It will compare the effectiveness of these personalized diets against a general healthy diet based on national guidelines in improving cardio-metabolic health markers. The study will involve 120 participants aged 40 to 70 with a BMI of 27-35, who will undergo a series of meal tests to assess their metabolic responses. The research will be conducted at three sites across Sweden, Norway, and the Netherlands.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 40 to 70 with a BMI between 27 and 35 who do not have a history of cardiovascular disease or diabetes.
Not a fit: Patients with diagnosed cardiovascular disease, diabetes, or certain gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective dietary interventions tailored to individual metabolic responses, improving overall health outcomes.
How similar studies have performed: Other studies have shown promise in personalized nutrition approaches, suggesting potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women * Age 40 to 70 years * Body mass index (BMI) 27-35 kg/m2 * Signed informed consent Exclusion Criteria: * History of diagnosed cardiovascular disease (e.g. stroke, heart disease) * Diagnosed type 1 or type 2 diabetes * Finger prick glucose test at screening indicating diabetes (fasting \>6.9 mmol/L; non-fasting \>11.0 mmol/L) * Antibiotic use in the last 3 months * Taking medication that can interfere with the planned outcome measures, as judged by the study physician (e.g. peroxisome proliferator-activated receptor-α \[PPAR-α\] or PPAR-γ agonists \[fibrates\], sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin, chronic use of NSAIDs). Statins and hypertension medication are allowed if the medication regimen has been stable for the last three months * Stomach and gastrointestinal conditions (e.g. Morbus Chron, Ulcerative colitis, irritable bowel syndrome, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.) * History of major gastrointestinal surgery * Anaemia: Hb concentrations \< 8.5 mmol/L for men and \< 7.5 mmol/L for women * Recent blood donation (within 2 months prior to the screening) * Recent participation in another intervention study (within 2 months prior to the screening) * Allergy or intolerance to medical skin adhesives * Chronic or acute inflammatory conditions (e.g., rheumatoid arthritis, psoriatic arthritis) * Autoimmune disorders * Thyroid disorders * Significant renal or liver dysfunction or chronic kidney or liver disease * Known food allergies/intolerances to intervention foods or food products used in the study * Following specific dietary regimen that could impact results or not suitable for the study design (e.g. vegetarian, vegan) * Habitual tobacco consumption (e.g. smoking, use of snus, vaping) * Alcohol intake ≥ 14 alcoholic beverages/week for women and ≥ 21 alcoholic beverages/week for men * Current or planned pregnancy or lactating * Other serious medical conditions that could interfere with participation or study outcomes * Unable to sufficiently understand written and spoken national language (where the study centre is located) to provide written consent and understand information and instructions from the study personnel. * Deemed unsuitable for participation in the trial, for any reason, as judged by the research physician or PI. * Working at the division conducting the trial at any of the three study centres. * Do not have a mobile phone that is suitable for the use of a research app.
Where this trial is running
Wageningen and 2 other locations
- Wageningen University and Research, Human research unit — Wageningen, Netherlands (Recruiting)
- Department of nutrition, University of Oslo — Oslo, Norway (Recruiting)
- University of Gothenburg, Department of Internal medicin and Clinical nutrition — Gothenburg, Sweden (Recruiting)
Study contacts
- Study coordinator: Rikard Landberg, PhD
- Email: rikard.landberg@chalmers.se
- Phone: +46723509386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.