NCT04641559

Brief Summary

The alteration maintained over time of some metabolic processes, such as oxidative stress, low-grade inflammation, carbohydrate and lipid metabolism, and of the intestinal microbiota activity, can induce some chronic diseases with high prevalence in society, such as obesity, cardiovascular disease or diabetes. These metabolic alterations can be modulated through nutrition and eating habits. Thus nutritional interventions are currently considered as a main tool for disease prevention. The need to adapt nutritional interventions to the particular needs of each person in order to improve the health status of all individuals is becoming more and more evident, through precision nutrition. On the other hand, for nutritional interventions to be carried out over long periods of time and to achieve sustainable long-term changes in lifestyle, new forms of behavioral counseling are necessary to facilitate the follow-up of nutritional interventions. PREVENTOMICS is a European project that arose to develop a personalized nutrition system, the PREVENTOMICS system. This system is based on the classification of the users of the system according to the state of their own metabolic processes, their genotype, their dietary habits and preferences, levels of physical activity, purchase preference and possible allergies, in order to provide a personalized nutrition adapted to the needs of each user. The PREVENTOMICS system is presented through a digital environment via computer, with a list of products provided by the ALDI supermarket to prepare the shopping list, without having to buy the products from the ALDI supermarket.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

December 9, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
Last Updated

March 2, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

November 2, 2020

Last Update Submit

March 1, 2022

Conditions

Personalized NutritionHealth StatusDietary Habits

Keywords

Metabolic statusgut microbiotaBehavioural interventionMediterranean dietRetailer websitePreventomicsDigital environment

Outcome Measures

Primary Outcomes (1)

  • Change in Adherence to Mediterranean diet.

    Adherence to Mediterranean diet measured through the MEditerranean Diet Adherence Screener (MEDAS). The questionnaire consists of 14 questions about eating habits, the frequency of consumption of typical foods of the Mediterranean diet or the consumption of foods not recommended in this diet. Each question is screened with 0 (non-compliant) or 1 (compliant) and the total score range from 0 to 14, so a score of 14 points mean maximum adherence.

    At weeks 2 and 25.

Secondary Outcomes (71)

  • Change in body weight.

    At weeks 2 and 25

  • Height.

    At weeks 2

  • Change in BMI

    At weeks 2 and 25

  • Change in waist circumference.

    At weeks 2 and 25

  • Change in blood pressure (in mmHg).

    At weeks 2 and 25

  • +66 more secondary outcomes

Study Arms (3)

Personalized nutrition group

EXPERIMENTAL

Intervention group that will receive personalized nutrition advice through the ALDI's catalogue during four months.

Other: Personalized nutrition group

Personalized Plan group

EXPERIMENTAL

Intervention group that will receive personalized nutrition advice through the ALDI's catalogue and behavioural change program during four months.

Other: Personalized Plan group

Control group

PLACEBO COMPARATOR

General recommendations but not personalization nor behavioural change advice will be implemented during four months.

Other: Control group

Interventions

Personalized nutrition groupOTHER

A digital environment which combines biological information, personal habits and preference to provide nutritional recommendations. This digital environment is composed by the follow softwares:1. The recommender system: software that combine the behavioral and biological information about the volunteer and generates personalized nutritional recommendations; 2. The ALDI microsite: A microsite that retrieves the personalized recommendations for the volunteer from the recommender system. The ALDI microsite matches food categories with products of the ALDI catalogue. As a result, the volunteer receives a list of products classified under different food categories that are recommended for him/her. Next to each food category, the number of servings recommended (weekly or daily) is also shown. The ALDI microsite is a tool only to elaborate a shopping list through personalized recommendations. Therefore, volunteers can choose to buy their food shopping list at wherever store other from ALDI.

Personalized nutrition group
Personalized Plan groupOTHER

Participants will use the same software described in for the Personalized nutrition group together with a behavioral change program designed to increase the adherence to the recommendations provided by the ALDI microsite by promoting a proper attitude by means of a series of personalized, goal-orientated, friendly, achievable actions delivered periodically to the volunteer. The behavioral change program will be fed with the results of behavior questionnaires. The personalized messages will be delivered through the ALDI microsite. These personalized messages will be available only for those subjects engaged in the Personalized Plan group.

Personalized Plan group
Control groupOTHER

The participants in the control group will not have personalized recommendations. These participants will have access to a restricted version of the ALDI microsite where the list of recommended products correspond to categories that are general recommendations according to Mediterranean diet.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women.
  • Signed informed consent.
  • To have internet access.

You may not qualify if:

  • Diabetes (or glucose ≥ 126 mg/dL or pharmacological treatment).
  • Hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg or pharmacological treatment).
  • Dyslipidaemia (cLDL ≥4.9 mmol/L and/or triglycerides ≥4.5 mmol/L (≥400 mg/dL) and/or cHDL \<40 mg/dL (1.03 mmol/L) in men and \<50 mg/dL (1.29 mmol/L) in women) or with pharmacological treatment.
  • Use of prescribed medicine to control acute or chronic inflammation.
  • Anaemia (haemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
  • BMI (in kg/m2) \<18.5 or \>35.
  • Being pregnant or planning to become pregnant within the study period.
  • Be in breastfeeding period.
  • Current smokers.
  • Present some chronic gastrointestinal disease.
  • Present some chronic disease with clinical manifestation, like coronary heart diseases, cardiovascular disease, coeliac disease, Crohn's disease and chronic kidney disease (or serum creatinine ≥1.7 mg/dL for men and ≥1.5 mg/dL for women).
  • Following a prescribed diet for any reason, including weight loss, in the last 3 months.
  • Following a pharmacological treatment for weight loss or intake of food supplements or medications that could affect body weight.
  • Having allergies or food intolerances.
  • No or limited access to the Internet.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)

Reus, Tarragona, 43204, Spain

Location

Related Publications (1)

  • Calderon-Perez L, Escote X, Companys J, Alcaide-Hidalgo JM, Bosch M, Rabassa M, Crescenti A, Valls RM, Pedret A, Sola R, Marine R, Gil-Cardoso K, Rodriguez MA, Palacios H, Del Pino A, Guirro M, Canela N, Sunol D, Galofre M, Galmes S, Palou-March A, Serra F, Caimari A, Gutierrez B, Del Bas JM. A single-blinded, randomized, parallel intervention to evaluate genetics and omics-based personalized nutrition in general population via an e-commerce tool: The PREVENTOMICS e-commerce study. Am J Clin Nutr. 2024 Jul;120(1):129-144. doi: 10.1016/j.ajcnut.2024.04.004. Epub 2024 May 23.

    PMID: 38960570DERIVED

Related Links

MeSH Terms

Conditions

Feeding Behavior

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Josep M Del Bas, PhD

    UTNS (Eurecat_Reus)

    PRINCIPAL INVESTIGATOR

  • Josep M Del Bas, PhD

    UTNS (Eurecat_Reus)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 24, 2020

Study Start

December 9, 2020

Primary Completion

December 23, 2021

Study Completion

December 23, 2021

Last Updated

March 2, 2022

Record last verified: 2022-03

Locations

ES(1)