Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases

NCT06923644 | Recruiting

• 1 other identifier: NL87817.068.24
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

Nutrition is very important to keep blood sugar levels balanced. If blood sugar levels are too high, it can lead to diseases such as cardiovascular disease and type 2 diabetes (T2DM). Therefore, adjusting what one eats, also called a diet or nutritional intervention, can help prevent these diseases. However, not everyone responds the same to a diet. In about 30% of people, a diet does not work as hoped. This can be due to various reasons, such as a person's metabolism, genetic predisposition, the composition of the food one eats, or the bacteria in the intestines. Everyday things like sleep, stress, and movement also play a role. The investigators used a computer model to classify people with overweight and obesity into groups based on these factors. The investigators call such a group a 'Metabolic Phenotype', or in short 'Metabotype'. Based on the Metabotype, a personalised diet was developed (personalised nutrition intervention) that may better suit each person's unique situation. The investigators hypothesize that a precision nutrition intervention, tailored to Metabotypes identified through unsupervised clustering (using the aforementioned computer model) of predefined, accurate features related to cardiometabolic health-specifically, tissue-specific glucose and lipid metabolism and detailed body composition-will enhance blood glucose homeostasis, reduce cardiometabolic risk, and improve adherence to the intervention and mental well-being, compared to population-based dietary guidelines. The present project will contribute to targeted and efficient precision-based dietary strategies for individuals at increased risk of T2DM.

Conditions

Obesity and Overweight; Pre-diabetic; Type 2 Diabetes Mellitus (T2DM)

Keywords

Dietary intervention trial; Precision nutrition; Tissue-specific insulin resistance; Body composition; Metabotyping; Glucose homeostasis; Cardiometabolic health; Insulin resistance; Metabolic phenotype

Outcome Measures

Primary Outcomes (1)

• Matsuda Index

  The primary objective of this study is to evaluate the effect of a 12-month Metabotype-targeted diet (PN) versus a non-targeted diet (CN) on whole-body insulin sensitivity (Matsuda Index; marker of whole-body fasting and postprandial insulin sensitivity). This will include within group post-hoc testing. The primary outcome measure will be assessed by means of a 7-point oral glucose tolerance test (OGTT), and calculated as follows: \[10,000 / square root of \[fasting plasma glucose (mg/dL) × fasting insulin (mU/L)\] × \[mean glucose (mg/dL) x mean insulin (mU/L)\]\].

  Change from baseline at month 6 and month 12 following dietary intervention.

Secondary Outcomes (46)

• Glucose tolerance

  Change from baseline at month 6 and month 12 following dietary intervention.

• Disposition Index (DI)

  Change from baseline at month 6 and month 12 following dietary intervention.

• HOMA-IR

  Change from baseline at month 6 and month 12 following dietary intervention.

• Muscle insulin sensitivity (MISI)

  Change from baseline at month 6 and month 12 following dietary intervention.

• Hepatic insulin resistance (HIRI)

  Change from baseline at month 6 and month 12 following dietary intervention.

Other Outcomes (3)

• Baseline characteristics

  Baseline

• Metabotype cluster

  Baseline, and change from baseline at month 6 and month 12 following dietary intervention.

• Capillary Blood Samples (CBS)

  Baseline and following 12 month dietary intervention.

Study Arms (2)

Precision Nutrition Group (PN)

EXPERIMENTAL

For a total duration of 12 months, participants in the Precision Nutrition (PN) Group will follow a diet tailored to their Metabotype, which is hypothesised to be optimal for them.

Other: Optimal Metabotype-specific diet

Control Group (CN)

EXPERIMENTAL

For a total duration of 12 months, participants in the Control Group (CN) will be randomly assigned one of the diets optimised for a different Metabotype of the same sex, which is hypothesised to be suboptimal for them.

Other: Sub-optimal diet

Interventions

Optimal Metabotype-specific diet OTHER

Following screening, baseline measurements, and determination of Metabotype, participants will be randomly assigned, using minimisation, to either the Precision Nutrition (PN) group or the Control (CN) group. The PN group will receive a diet hypothesised to be optimal for their specific Metabotype. All participants will adhere to their assigned diets for 12 months. Each Metabotype-specific diet will align with the Dutch Healthy Dietary Guidelines, while varying in macronutrient composition and quality.

Precision Nutrition Group (PN)

Sub-optimal diet OTHER

Participants randomised to the Control Group (CN), will be randomly assigned one of the two diets optimised for a different Metabotype of the same sex. The assigned CN Group diet will always have a macronutrient content and quality that is different than their hypothesised optimal diet. All diets will align with the Dutch Healthy Dietary Guidelines.

Control Group (CN)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with a BMI ≥25 to \<40 kg/m2
• Classification possible to one of the investigational metabolic phenotypes according to the classification algorithm.
• Weight stability for at least 3 months (+/- 3 kg)

You may not qualify if:

• Diseases
• (Pre-)diagnosis of type 1 or type 2 diabetes mellitus (i.e., FPG ≥ 7,0 mmol/L) and HbA1c ≥ 6,5% (48 mmol/mol)
• Renal or hepatic malfunctioning (pre-diagnosis or determined based on ALAT and creatinine values)
• Gastrointestinal diseases or abdominal surgery (allowed i.e.:
• appendectomy, cholecystectomy)
• Food allergies, intolerances (including gluten/lactose intolerance) and/or eating disorders interfering with the study
• Cardiovascular diseases (e.g., heart failure) or cancer (e.g., noninvasive skin cancer allowed)
• High systolic blood pressure (untreated \>160/100 mmHg, drug-regulated \>140/90 mmHg)
• Diseases affecting glucose and/or lipid metabolism (e.g., pheochromocytoma, Cushing's syndrome, acromegaly)
• Diseases with a life expectation shorter than 5 years
• Major mental disorders
• Other physical/mental conditions that may interfere with study outcomes
• Medication
• Medication known to interfere with study outcomes (e.g., PPAR-α or PPAR-γ agonists (fibrates), sulfonylureas, biguanides, α-glucosidaseinhibitors, thiazolidinediones, repaglinide, nateglinide, insulin, and chronic use of NSAIDs)
• Use of certain anticoagulants other than acetylsalicylic acid

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Wageningen University and Research: collaborator
• Health Holland: collaborator
• TKI Agri & Food: collaborator
• Nestle Health Science: collaborator
• Beneo GmbH: collaborator
• BARILLA G. e R. Fratelli S.p.A., Parma, Italy: collaborator

Study Sites (2)

Maastricht University Medical Center, Department of Human Biology, NUTRIM Institute of Nutrition and Translational Research in Metabolism

Maastricht, 6200MD, Netherlands

RECRUITING

Wageningen University and Research, Division of Human Nutrition

Wageningen, 6700AA, Netherlands

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Glucose Intolerance; Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Ellen E Blaak, Prof. Dr. Ir.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen E Blaak, Prof. Dr. Ir.

CONTACT

+31433881503; e.blaak@maastrichtuniversity.nl

Art Muijsenberg, MSc

CONTACT

+31433882862; art.muijsenberg@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: April 11, 2025
• Study Start: April 23, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Possibly, based on guidelines in the consortium agreement, the steering committee could agree on an embargo period, which could delay the accessibility of (part of) the data. One of the reasons for delayed data access may be the application for IP rights and marketing of the acquired knowledge (by consortium partners).
• Access Criteria: * The purpose of data access is limited to scientific purposes and may not be used for commercial purposes; * The purpose of the data request must be of public interest. Research questions of the data access applicant must be related to the research topic of the original study; * The dataset must not be linked to an external dataset (for privacy reasons); * Use of the dataset is not infinite, but only for a predetermined period, a time interval required for analyses of data up to a maximum of 3 months (and once for this specific question by this applicant); * A small fee is requested for (re)use of the data. This fee will cover the additional costs associated with assessing the request and distributing the data; * If the purpose of data access is scientific publication, agreements must be made in advance on co-authorship, access to the final manuscript and the possibility of stopping the publication of data up to a period of 3 months if no agreement can be reached between parties.

Locations

NL (2)