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Search / Trial NCT06842433

The NUTRIOME Study - a Data-driven Precision Nutrition Intervention

Launched by CHALMERS UNIVERSITY OF TECHNOLOGY · Feb 19, 2025

Trial Information

Current as of July 08, 2025

Recruiting

Keywords

ClinConnect Summary

The NUTRIOME Study is a research trial aimed at helping individuals with metabolic control by creating personalized dietary advice based on how their bodies respond to different types of meals. The main goal is to see if this tailored diet is more effective for improving heart and metabolic health compared to general healthy eating guidelines. The study will involve 120 men and women, aged 40 to 70, with a body mass index (BMI) between 27 and 35. Eligible participants will be recruited from three locations: Sweden, the Netherlands, and Norway.

Participants can expect to take part in two phases of the study. The first phase includes a series of meal tests to understand how different foods affect their metabolism. Based on these responses, a personalized diet will be created. In the second phase, participants will follow this customized diet for six weeks and compare their results to those following a standard healthy diet. It’s important to note that individuals with certain health conditions, such as diabetes or heart disease, or those taking specific medications may not be suitable for participation. If you're interested and meet the criteria, this could be a great opportunity to explore how personalized nutrition can benefit your health!

Gender

ALL

Eligibility 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.

About Chalmers University Of Technology

Chalmers University of Technology, located in Gothenburg, Sweden, is a leading research institution known for its innovative contributions to engineering, technology, and natural sciences. As a clinical trial sponsor, Chalmers leverages its interdisciplinary expertise and cutting-edge research capabilities to advance healthcare solutions and improve patient outcomes. The university collaborates with various stakeholders, including industry partners and healthcare providers, to conduct rigorous clinical studies that adhere to the highest ethical and scientific standards. Through its commitment to innovation and research excellence, Chalmers aims to translate scientific discoveries into practical applications that benefit society.

Locations

Wageningen, , Netherlands

Oslo, , Norway

Gothenburg, , Sweden

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported