Actively Recruiting
The NUTRIOME Study - a Data-driven Precision Nutrition Intervention
Led by Chalmers University of Technology · Updated on 2025-03-21
120
Participants Needed
3
Research Sites
67 weeks
Total Duration
On this page
Sponsors
C
Chalmers University of Technology
Lead Sponsor
U
University of Oslo
Collaborating Sponsor
AI-Summary
What this Trial Is About
The overall objective of this multi-center study is to use metabolic response data from different dietary challenges to develop personalized dietary advice. Effectiveness of this personalized dietary advice compared to a general healthy diet based on national dietary guidelines on markers of cardio-metabolic health will be tested. A total of 120 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate. The study will be conducted at three sites: Chalmers University of Technology (Sweden), University of Wageningen (Netherlands), and University of Oslo (Norway), with 40 participants per site.The study is conducted in two parts. The first part, the characterization phase, is a three-way randomized, controlled cross-over design, featuring one-day meal tests with isocaloric meals containing different carbohydrate, fat and protein quantity as well as quality. Based on the metabolic response to the meal tests a personalized diet will be constructed. In the second part, the main intervention, effectiveness of this personalized dietary advice compared to a general healthy diet will be tested in a six week parallel group intervention study.
CONDITIONS
Official Title
The NUTRIOME Study - a Data-driven Precision Nutrition Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women
- Age 40 to 70 years
- Body mass index (BMI) 27-35 kg/m2
- Signed informed consent
You will not qualify if you...
- 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. 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 stable for last 3 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 screening)
- Recent participation in another intervention study (within 2 months prior to 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 of study center to provide consent and understand instructions
- Deemed unsuitable for participation by research physician or PI
- Working at division conducting the trial at any study center
- Do not have a mobile phone suitable for use of research app
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Wageningen University and Research, Human research unit
Wageningen, Netherlands
Actively Recruiting
2
Department of nutrition, University of Oslo
Oslo, Norway
Actively Recruiting
3
University of Gothenburg, Department of Internal medicin and Clinical nutrition
Gothenburg, Sweden
Actively Recruiting
Research Team
R
Rikard Landberg, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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