The NUTRIOME Study - a Data-driven Precision Nutrition Intervention (NUTRIOME)

The NUTRIOME Meal Study - a Data-driven Precision Nutrition Intervention Study Using Meal Responses

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Control
• Intervention / Treatment: Other: General healthy diet; Other: Personalized diet

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rikard Landberg, PhD; Phone Number: +46723509386; Email: rikard.landberg@chalmers.se

Study Locations

• Netherlands
  • Wageningen, Netherlands
    • Recruiting
    • Wageningen University and Research, Human research unit
    • Contact: Lydia Afman; Phone Number: +31317485789; Email: lydia.afman@wur.nl
• Norway
  • Oslo, Norway
    • Recruiting
    • Department of Nutrition, University of Oslo
    • Contact: Stina Marie Ulven; Phone Number: +4722840208; Email: smulven@medisin.uio.no
• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • University of Gothenburg, Department of Internal medicin and Clinical nutrition
    • Contact: Rikard Landberg; Phone Number: +46317722732; Email: rikard.landberg@chalmers.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General healthy diet; General healthy diet based on national health dietary guidelines.	Other: General healthy diet; General healthy diet based on national health dietary guidelines.
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory markers in blood	Differences in immunological responses (such as cytokines, lipopolysaccharides, GlycA) between test meals in the characterization phase of the study.	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.	6-hour meal test
Gut microbiome	Differences in fecal microbiome between test meals in the characterization phase of the study.	6-hour meal test
Metabolome	Differences in metabolome (plasma, urine and feces) between test meals in the characterization phase of the study.	6-hour meal test
Lipid metabolism	Differences in lipid metabolism between test meals in the characterization phase of the study.	6-hour meal test
Glycemic variability	Differences in glycemic variability across the different meals and the OGTT throughout the characterization phase of the study.	4 weeks
Gastrointestinal hormones	Release of gastrointestinal hormones (such as GLP-1, CCK) in response to the test meals in the characterization phase of the study.	6-hour meal test
Fecal proteome	Differences in fecal proteome between test meals in the characterization phase of the study.	6-hour meal test
PBMC Transcriptome	Differences in peripheral blood mononuclear cell gene expression between test meals in the characterization phase of the study.	6-hour meal test
PBMC Epigenome	Differences in peripheral blood mononuclear cell epigenome between test meals in the characterization phase of the study.	6-hour meal test
PBMC Immunometabolism	Differences in peripheral blood mononuclear cell immunometabolism between test meals in the characterization phase of the study.	6-hour meal test
Metabolome	Difference in metabolome (plasma, urine and feces) between personalized diet and general healthy diet in the intervention phase of the study.	6 weeks
PBMC Epigenome	Difference in peripheral blood mononuclear cell epigenome between personalized diet and general healthy diet in the intervention phase of the study.	6 weeks
PBMC Transcriptome	Difference in peripheral blood mononuclear cell transcriptome between personalized diet and general healthy diet in the intervention phase of the study.	6 weeks
PBMC Immunometabolism	Difference in peripheral blood mononuclear cell immunometabolism between personalized diet and general healthy diet in the intervention phase of the study.	6 weeks
Fecal proteome	Difference in fecal proteome between personalized diet and general healthy diet in the intervention phase of the study.	6 weeks
Gut microbiome	Difference in fecal microbiome between personalized diet and general healthy diet in the intervention phase of the study.	6 weeks
Inflammatory markers in blood	Differences in immunological responses (such as cytokines, lipopolysaccharides, GlycA) to mixed meal tolerance tests between personalized diet and general healthy diet in the intervention phase of the study.	6 weeks
Glycemic variability	Differences in glycemic variability between personalized diet and general healthy diet in the intervention phase of the study.	6 weeks
Data-driven prediction of response to intervention	Data-driven prediction of primary and other outcomes to personalized diet vs. general healthy diet using metabolome, gut microbiome, epigenome, transcriptome, proteome, immunometabolism, health measures, lifestyle and metabolic markers as determinants.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	6-hour test meal
Gastric passage time	Gastric passage time will be assessed using the blue dye method.	6-hour meal test and 6 week intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Nutriome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No