Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences

NCT04590989 | Completed

• 1 other identifier: B-361
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity; Metabolic Syndrome

Keywords

Nutrigenomics; Nutrigenetics; Metabolomics; Microbiome; Precision nutrition; Personalized nutrition; Weight management; Body weight; Obesity

Outcome Measures

Primary Outcomes (1)

• 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).

  Fat mass is evaluated by use of Dual X-ray absorptiometry (DXA) scans. The DXA-scan (iDXA, Lunar Radiation Co., Madison, Wisconsin, USA) is performed at V2 and V3 to calculate the difference between the two measurements.

  Baseline (V2) and week 10 (V3).

Secondary Outcomes (6)

• Change in body composition from baseline to week 10: visceral and subcutaneous fat, body lean mass, weight, body mass index, waist circumference

  Baseline (V2) and week 10 (V3).

• Change in lipid profile (fasting) from baseline to week 10: total, LDL and HDL cholesterol, triglycerides, atherogenic index of plasma (AIP)

  Baseline (V2) and week 10 (V3).

• Change in blood glucose, insulin, HOMA-IR (fasting) from baseline to week 10

  Baseline (V2) and week 10 (V3).

• Change in inflammatory biomarkers (fasting) - CRP, IL-6, MCP1, TNFα, IL-10, soluble ICAM1, soluble CD14 from baseline to week 10

  Baseline (V2) and week 10 (V3).

• Change in adipokines (fasting) - Leptin, Adiponectin, Leptin/Adiponectin ratio from baseline to week 10

  Baseline (V2) and week 10 (V3).

Other Outcomes (10)

• Energy and macronutrient intake

  Measurements visit (V1) and week 10 (V3).

• Quality of life assessment

  Baseline (V2) and week 10 (V3).

• Physical activity and sleep patterns

  In 7 days/8 nights post visit 1 and 7 days/8 nights during the 10-week study (between V2 and V3).

Study Arms (2)

Personalized Plan (PP)

EXPERIMENTAL

Each subject in the PP group will be allocated to one of five clusters based on their metabolic and genetic health biomarkers from samples of urine, plasma, serum, and saliva. 58 biomarkers will be included to characterize the 5 metabolic clusters/processes in the PREVENTOMICS platform: 1) oxidative stress; 2) inflammation; 3) carbohydrate metabolism; 4) lipid metabolism; 5) microbiota-generated metabolites. Eurecat Nutrition Team has prepared a list of recommended food items to increase and food to exclude/limit from the diet for each cluster. The list will be adopted by Simple Feast in creating five different menus that will encompass the 12 meals/week of breakfasts and dinners for the five different metabolic clusters. Additionally, subjects will receive personalized actionable "Do's" push notifications by ONMI. The messages are personalized based on user reports from the behavioral questionnaire at V2 in addition to inputs from the nutritional recommendations of food to increase.

Other: Personalized Nutrition Plan

Control Group

PLACEBO COMPARATOR

Dietary intervention: The second group of 50 subjects will receive meals from Simple Feast, after integrating their metabolic profile and other blood biomarkers by PREVENTOMICS, which are based on the national dietary guidelines. Behavioral intervention: Subjects will also receive nudges, after filling out ONMI's behavioral questionnaire at V2, but that will not be personalized (i.e. basic information that is available online from NHS and WHO).

Other: Non-Personalized Nutrition Plan

Interventions

Personalized Nutrition Plan OTHER

* Personalized breakfasts and dinners designed and cooked by Simplefeast, delivered twice a week (eaten 6 days per week) + access to Simplefeast's App for recipes of other meals not provided (i.e. lunches and Saturdays) which are designed to match the individual nutritional recommendations. * Personalized behavioral change program via electronic push notifications by ONMI

Personalized Plan (PP)

Non-Personalized Nutrition Plan OTHER

* Standard meals of breakfasts and dinners designed and cooked by Simple feast, based on general dietary recommendations, and delivered to participants twice a week. In addition, they will also have access to Simple feast's recipe App for other meals not provided. The recipes presented are generic, not personalized. * Subjects in the control group will also be enrolled in the behavioral program by ONMI, but the program will not be personalized nor based on the same behavior change methodology as in the PP group. In other words, the control group will get information more than is triggered to take actual action (i.e. general guidelines that is available from the National Health Service and World Health Organization).

Control Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Fundació Eurecat: collaborator
• Simple Feast: collaborator
• Alimentómica: collaborator
• University of Parma: collaborator
• ONMI: collaborator

Study Sites (1)

University of Copenhagen

Copenhagen, Frederiksberg, 1958, Denmark

Location

Related Publications (4)

• Galekop MMJ, Uyl-de Groot C, Redekop WK. Economic Evaluation of a Personalized Nutrition Plan Based on Omic Sciences Versus a General Nutrition Plan in Adults with Overweight and Obesity: A Modeling Study Based on Trial Data in Denmark. Pharmacoecon Open. 2024 Mar;8(2):313-331. doi: 10.1007/s41669-023-00461-8. Epub 2023 Dec 19.

  PMID: 38113009 DERIVED

• Aldubayan MA, Mao X, Laursen MF, Pigsborg K, Christensen LH, Roager HM, Nielsen DS, Hjorth MF, Magkos F. Supplementation with inulin-type fructans affects gut microbiota and attenuates some of the cardiometabolic benefits of a plant-based diet in individuals with overweight or obesity. Front Nutr. 2023 Apr 25;10:1108088. doi: 10.3389/fnut.2023.1108088. eCollection 2023.

  PMID: 37181156 DERIVED

• 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.

  PMID: 35839545 DERIVED

• 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.

  PMID: 35351696 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Mads F Hjorth, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Eligible participants will be randomly allocated to either intervention group (personalized plan) or control group prior to commencement of the trial. The allocation will be computer generated, and stratified by metabolic clusters (oxidative stress; inflammation; carbohydrate metabolism; lipid metabolism; microbiota-generated metabolites) in a 1:1 randomization between control and intervention groups. The person responsible for generating the code will not take part in the inclusion and examination of study participants. Study staff at UCPH and participants will be blinded to the treatment group and analyses of results will be performed in a blinded fashion. Moreover, the statistical analyses of the main outcome variable will be done without breaking the code for the intervention treatment, before the primary analyses are finalized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Head of Obesity Research Section

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 19, 2020
• Study Start: October 26, 2020
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Firstly, the IPD are to be shared within the PREVENTOMICS concortium \[Time Frame: Just after study completion\]. Secondly, the IPD will be made available upon request pending approval of a research proposal and statistical analysis plan and execution of a data sharing/prosessing agreement (according to GDPR) \[Time Frame: After publication of primary outcome and until 5-10 years after completion of study\]. Thirdly, the IPD will be made publically available for everyone once it is completely anonymised which is 5-10 years after completion of the study (according to GDPR) \[Time Frame: from 5-10 years after completion and forward\] .
• Access Criteria: See above

Locations

DK (1)