Phase
Condition
N/ATreatment
General healthy diet
Personalized diet
Clinical Study ID
Ages 40-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Men and women
Age 40 to 70 years
Body mass index (BMI) 27-35 kg/m2
Signed informed consent
Exclusion
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 bythe study physician (e.g. peroxisome proliferator-activated receptor-α [PPAR-α] orPPAR-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 beenstable for the last three months
Stomach and gastrointestinal conditions (e.g. Morbus Chron, Ulcerative colitis,irritable bowel syndrome, malabsorption, colostomy, bowel resection, gastric bypasssurgery 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 thescreening)
Allergy or intolerance to medical skin adhesives
Chronic or acute inflammatory conditions (e.g., rheumatoid arthritis, psoriaticarthritis)
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 thestudy
Following specific dietary regimen that could impact results or not suitable for thestudy 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 alcoholicbeverages/week for men
Current or planned pregnancy or lactating
Other serious medical conditions that could interfere with participation or studyoutcomes
Unable to sufficiently understand written and spoken national language (where thestudy centre is located) to provide written consent and understand information andinstructions from the study personnel.
Deemed unsuitable for participation in the trial, for any reason, as judged by theresearch 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.
Study Design
Connect with a study center
Wageningen University and Research, Human research unit
Wageningen,
NetherlandsActive - Recruiting
Department of nutrition, University of Oslo
Oslo,
NorwayActive - Recruiting
University of Gothenburg, Department of Internal medicin and Clinical nutrition
Gothenburg,
SwedenActive - Recruiting
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