The NUTRIOME Study - a Data-driven Precision Nutrition Intervention

ConditionMetabolic Control

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

General healthy diet
Other intervention
General healthy diet based on national health dietary guidelines.
Personalized diet
Other intervention
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.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: General healthy dietActive comparator 1 intervention

Group B: Personalized dietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Glucose postprandial

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

Time frame

6 weeks

Triglycerides postprandial

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

Time frame

6 weeks

Interleukin-6 postprandial

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

Time frame

6 weeks

Secondary outcomes

Inflammatory markers in blood

Differences in immunological responses (such as cytokines, lipopolysaccharides, GlycA) between test meals in the characterization phase of the study.

Time frame

6-hour meal test

Appetite

Differences in self-reported appetite measured using a visual analogue scale between test meals in the characterization phase of the study.

Time frame

6-hour meal test

Gut microbiome

Differences in fecal microbiome between test meals in the characterization phase of the study.

Time frame

6-hour meal test

Metabolome

Differences in metabolome (plasma, urine and feces) between test meals in the characterization phase of the study.

Time frame

6-hour meal test

Other outcomes

Dietary biomarkers

Exploratory analysis of blood, urine and feces to find potential biomarkers reflecting dietary intake in the characterization and intervention phase of the study.

Time frame

6-hour meal test and 6 week intervention

Responsivness to diet

Exploration of underlying mechanisms behind response/non-response to personalized and general healthy diet using data from both the characterization phase (meal test) and the primary 6-week intervention.

Time frame

6-hour test meal and 6 week intervention

Gastric emptying

Gastric emptying will be assessed by breath test at one of the test meals in a sub-group of participants (Swedish and Norwegian site).

Time frame

6-hour test meal

Gastric passage time

Gastric passage time will be assessed using the blue dye method.

Time frame

6-hour meal test and 6 week intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov

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