The NUTRIOME Study - a Data-driven Precision Nutrition Intervention

Last updated: March 20, 2025
Sponsor: Chalmers University of Technology
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

General healthy diet

Personalized diet

Clinical Study ID

NCT06842433
Nutriome
  • Ages 40-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

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

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: General healthy diet
Phase:
Study Start date:
March 14, 2025
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Wageningen University and Research, Human research unit

    Wageningen,
    Netherlands

    Active - Recruiting

  • Department of nutrition, University of Oslo

    Oslo,
    Norway

    Active - Recruiting

  • University of Gothenburg, Department of Internal medicin and Clinical nutrition

    Gothenburg,
    Sweden

    Active - Recruiting

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