The NUTRIOME Study - a Data-driven Precision Nutrition Intervention

NCT06842433 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-21

No results posted yet for this 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.

Conditions

  • Metabolic Control

Interventions

OTHER

General healthy diet

General healthy diet based on national health dietary guidelines.

OTHER

Personalized diet

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.

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER
  • Wageningen University

    collaborator OTHER
  • Polish Academy of Sciences

    collaborator OTHER
  • Maastricht University

    collaborator OTHER
  • German Cancer Research Center

    collaborator OTHER
  • University of Copenhagen

    collaborator OTHER
  • University of Oulu

    collaborator OTHER
  • University College Dublin

    collaborator OTHER
  • Chalmers University of Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-14
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Netherlands
  • Norway
  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06842433 on ClinicalTrials.gov