The NUTRIOME Study - a Data-driven Precision Nutrition Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorChalmers University of Technology

About this trial

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

Qualifiers

Men and women

Age 40 to 70 years

Body mass index (BMI) 27-35 kg/m2

Signed informed consent

Disqualifiers

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

Trial design

Treatments tested in this trial

  • General healthy diet
  • Personalized diet

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Chalmers University of Technology

Lead sponsor

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