Clinical trial NCT04590989: Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences
Official title: PREVENTOMICS: Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences - Danish Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Metabolic Syndrome
Keywords: Nutrigenomics
Nutrigenetics
Metabolomics
Microbiome
Precision nutrition
Personalized nutrition
Weight management
Body weight
Obesity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Fundació Eurecat
name: Simple Feast
name: Alimentómica
name: University of Parma
name: ONMI
First posted: 2020-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eurecat will grant Simple feast and ONMI access to users' profile via PREVENTOMICS Platform in order to know which group the subject is assigned to and intervene accordingly. The profile includes the assigned group/cluster along with nutritional recommendations of each subject.

100 individuals will be randomly assigned to one of the two intervention groups. Both groups will receive meals and recipes from Simple Feast. The control group (50 subjects) will receive meals based on general dietary recommendations whereas the meals of the personalized plan group (50 subjects) are personalized based on an analysis of their metabolic biomarkers, genetics, preferences, health status, and lifestyle habits.

In addition, ONMI will deliver a personally tailored and actionable behavior change program (Do-Omics) to the personalized plan group while the control group will receive general advice.
Primary purpose: TREATMENT

Brief summary: The over-all aim of this 10-week randomized-controlled study, taking place only in Denmark, is to examine whether the PREVENTOMICS platform integrated in an e-commerce digital tool created to deliver personalized meals and dietary advices is able to produce more favorable health effects than meals based on general dietary recommendations in overweight subjects with elevated waist circumference.

Detailed description: PREVENTOMICs project (Empowering consumers to PREVENT diet-related diseases through OMICS sciences), coordinated by Eurecat (Spain), has developed a personalized nutrition platform with a Decision Support System (DSS) tool that integrates different disease-inducing metabolic signatures with genotype and other informative information such as the characteristics of individual's behavioural traits, to correlate health status and provide personalized nutritional plan.

To demonstrate the potential for personalization of the platform, PREVENTOMICS will be validated in three different scenarios through three different organizations carrying out intervention studies with both healthy volunteers and volunteers with abdominal obesity.

The current study in Denmark will be a 10-week double-blinded randomized (1:1 randomization), placebo-controlled trial carried out with overweight/obese subjects having elevated waist circumference living in Greater Copenhagen. After the confirmation of the inclusion criteria, 100 individuals will be randomly assigned to one of the two intervention groups. Both groups will receive meals from Simple Feast following the national guidelines of macronutrient composition. The control group (n=50) will receive meals based on general dietary recommendations whereas the meals of the second group (n=50) are personalized based on metabolic biomarkers (PP group). In addition, participants of both groups will receive electronic push notifications of behavioral change messages for the purpose of general behavioral change and improving adherence to the nutritional intervention, which will be sent during the 10-week trial by ONMI. However, subjects in the PP group will receive personally tailored and actionable behavior change prompts from the predefined ONMI's program while subjects in the control group will receive it in a non-personalized fashion with standard messages.

Our hypothesis is that delivery of personalized meal/plan through the PREVENTOMICS platform integrated with e-commerce digital tool, will promote a greater reduction in fat mass and weight, as well as producing favorable changes in blood metabolic and inflammatory biomarkers compared to the control group.

Eligibility criteria: Inclusion Criteria:

* Men or women aged 18-65 years
* Body mass index (in kg/m2) of ≥27,0 and \<40,0 (overweight and class I and II obesity)
* Elevated waist circumference (Men\>94,0 cm; Women\>80,0 cm)
* Possess a smart mobile phone
* Able to provide written informed consent

Exclusion Criteria:

* Diagnosis of diabetes
* History or diagnosis of heart, liver or kidney disease
* Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer)
* Use of drugs, that in the opinion of the medically responsible investigator, are likely to affect the primary outcomes of the study
* Being lactating, pregnant or planning to become pregnant within the study period
* Participation within another clinical trial
* Other blood donation during the study
* Self-reported weight change of \>5 % (increase or decrease) within 2 months prior to screening.
* Having allergies or food intolerances
* No or limited access to the Internet
* Participants not able to comply with the study protocol judged by Investigator

Primary outcomes:
measure: Change in body fat mass from baseline to week 10 will be analyzed by means of linear mixed models including sex, age and BMI at baseline as fixed effects as well as the stratification variable (cluster).
timeFrame: Baseline (V2) and week 10 (V3).
Secondary outcomes:
measure: Change in body composition from baseline to week 10: visceral and subcutaneous fat, body lean mass, weight, body mass index, waist circumference
timeFrame: Baseline (V2) and week 10 (V3).
measure: Change in lipid profile (fasting) from baseline to week 10: total, LDL and HDL cholesterol, triglycerides, atherogenic index of plasma (AIP)
timeFrame: Baseline (V2) and week 10 (V3).
measure: Change in blood glucose, insulin, HOMA-IR (fasting) from baseline to week 10
timeFrame: Baseline (V2) and week 10 (V3).
measure: Change in inflammatory biomarkers (fasting) - CRP, IL-6, MCP1, TNFα, IL-10, soluble ICAM1, soluble CD14 from baseline to week 10
timeFrame: Baseline (V2) and week 10 (V3).
measure: Change in adipokines (fasting) - Leptin, Adiponectin, Leptin/Adiponectin ratio from baseline to week 10
timeFrame: Baseline (V2) and week 10 (V3).
measure: Change in blood pressure from baseline to week 10
timeFrame: Baseline (V2) and week 10 (V3).
Other outcomes:
measure: Energy and macronutrient intake
timeFrame: Measurements visit (V1) and week 10 (V3).
measure: Quality of life assessment
timeFrame: Baseline (V2) and week 10 (V3).
measure: Physical activity and sleep patterns
timeFrame: In 7 days/8 nights post visit 1 and 7 days/8 nights during the 10-week study (between V2 and V3).
measure: Stress assessment
timeFrame: Baseline (V2) and week 10 (V3).
measure: Eating behavior
timeFrame: Baseline (V2) and week 10 (V3).
measure: Attitude to weight management diets
timeFrame: Baseline (V2) and week 10 (V3).
measure: Money expended on food per household
timeFrame: Baseline (V2) and week 10 (V3).
measure: Liver and renal health markers (ALT, GGT, Uric acid, Creatinine)
timeFrame: Baseline (V2) and week 10 (V3).
measure: Microbiota composition
timeFrame: Baseline (V2) and week 10 (V3).
measure: Urine and blood metabolome
timeFrame: Baseline (V2) and week 10 (V3).
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
state: Frederiksberg
Study officials:
affiliation: University of Copenhagen
name: Mads F Hjorth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aldubayan MA, Pigsborg K, Gormsen SMO, Serra F, Palou M, Galmes S, Palou-March A, Favari C, Wetzels M, Calleja A, Rodriguez Gomez MA, Castellnou MG, Caimari A, Galofre M, Sunol D, Escote X, Alcaide-Hidalgo JM, M Del Bas J, Gutierrez B, Krarup T, Hjorth MF, Magkos F. A double-blinded, randomized, parallel intervention to evaluate biomarker-based nutrition plans for weight loss: The PREVENTOMICS study. Clin Nutr. 2022 Aug;41(8):1834-1844. doi: 10.1016/j.clnu.2022.06.032. Epub 2022 Jun 30.
citation: Aldubayan MA, Pigsborg K, Gormsen SMO, Serra F, Palou M, Mena P, Wetzels M, Calleja A, Caimari A, Del Bas J, Gutierrez B, Magkos F, Hjorth MF. Empowering consumers to PREVENT diet-related diseases through OMICS sciences (PREVENTOMICS): protocol for a parallel double-blinded randomised intervention trial to investigate biomarker-based nutrition plans for weight loss. BMJ Open. 2022 Mar 29;12(3):e051285. doi: 10.1136/bmjopen-2021-051285.