The NUTRIOME Study - a Data-driven Precision Nutrition Intervention

NCT06842433 | Recruiting

• 1 other identifier: Nutriome
• Study Type: interventional
• Target: 120
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Metabolic Control

Outcome Measures

Primary Outcomes (3)

• Glucose postprandial

  Difference between groups in postprandial glucose in response to a mixed meal tolerance test.

  6 weeks

• Triglycerides postprandial

  Difference between groups in postprandial triglycerides in response to a mixed meal tolerance test.

  6 weeks

• Interleukin-6 postprandial

  Difference between groups in postprandial interleukin-6 in response to a mixed meal tolerance test.

  6 weeks

Secondary Outcomes (20)

• Inflammatory markers in blood

  6-hour meal test

• Appetite

  6-hour meal test

• Gut microbiome

  6-hour meal test

• Metabolome

  6-hour meal test

• Lipid metabolism

  6-hour meal test

Other Outcomes (4)

• Dietary biomarkers

  6-hour meal test and 6 week intervention

• Responsivness to diet

  6-hour test meal and 6 week intervention

• Gastric emptying

  6-hour test meal

Study Arms (2)

General healthy diet

ACTIVE COMPARATOR

General healthy diet based on national health dietary guidelines.

Other: General healthy diet

Personalized diet

EXPERIMENTAL

Personalized diet will be based on an algorithm considering the individuals' postprandial glucose, triglycerides and inflammation markers to each of the three study meals in the characterization phase (Phase I) matched with established knowledge about the effects of specific foods on such metabolic parameters

Other: Personalized diet

Interventions

General healthy diet OTHER

General healthy diet based on national health dietary guidelines.

General healthy diet

Personalized diet OTHER

Personalized diet will be based on an algorithm considering the individuals' postprandial glucose, triglycerides and inflammation markers to each of the three study meals in the characterization phase (Phase I) matched with established knowledge about the effects of specific foods on such metabolic parameters.

Personalized diet

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• Age 40 to 70 years
• Body mass index (BMI) 27-35 kg/m2
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Chalmers University of Technology: lead
• University of Oslo: collaborator
• Wageningen University: collaborator
• Polish Academy of Sciences: collaborator
• Maastricht University: collaborator
• German Cancer Research Center: collaborator
• University of Copenhagen: collaborator
• University of Oulu: collaborator
• University College Dublin: collaborator

Study Sites (3)

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

Central Study Contacts

Rikard Landberg, PhD

CONTACT

+46723509386; rikard.landberg@chalmers.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The dietary intervention of personalized dietary advice vs. general healthy diet will be blinded and matched for delivery of intervention and intensity. Wherever possible Care providers and researchers conducting the analysis (e.g., nurses drawing blood samples) will be blinded to the allocation of intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 24, 2025
• Study Start: March 14, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

SE (1); NO (1); NL (1)