INNUPREC (Nutrigenetic Intervention for the Prevention of Cardiovascular Disease)

NCT06847243 | Not Yet Recruiting DMC

• 1 other identifier: CI-05223
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Abdominal obesity (AO) is a multifactorial disease that affects 81.6% of the Mexican population; it is characterized by the excessive accumulation of adipose tissue in abdominal region. Scientific evidence suggest that regional fat distribution plays a critical role in the development of cardiovascular diseases (CVD). The main processes involved in the increased risk of developing CVD in the presence of AO are alterations in insulin signaling, dyslipidemias, atherosclerosis, inflammation, and oxidative damage. On the last years has been reported genetic variations associated with AO and dyslipidemia. In addition, interactions have been found between these genetic variants and diet that may be influencing a differential response in metabolic, molecular, and phenotypic processes, which favor the development of CVD. Objective: Evaluate the effect of nutrigenetic intervention on cardiovascular biomarkers, oxidative stress and antioxidant capacity in subjects with abdominal obesity. Materials and methods: The present study is a simple randomized clinical trial. Participants will be randomized into one of two groups of intervention; Control group and Nutrigenetic group during a 2-month follow-up period. Anthropometric, dietary evaluation and biochemical markers assessments will be monitored at baseline, at 4 weeks (mid-intervention), and at 8 weeks (end of intervention). The dietary evaluation was analyzed by Nutritionist Pro software. Body composition was evaluated by electrical bioimpedance (InBody 370). All biochemical determinations were analyzed by dry chemistry (Vitros 350) and cardiometabolic markers by colorimetric immunoassay technology. Infrastructure: Institute of Translational Nutrigenomics and Nutrigenomics, University Center for Health Sciences, University of Guadalajara.

Conditions

Abdominal Obesity

Keywords

Abdominal obesity; Nutrigenetic intervention; Cardiometabolic biomarkers

Outcome Measures

Primary Outcomes (1)

• Changes in Waist Circumference between nutrigenetic and control group

  Waist circumference is used as a diagnostic criterion for abdominal obesity, which is why it is the main change to be evaluated among our study groups. Waist circumference will be measure at the narrowest point between the edge of the inner rib and the iliac crest, with the participant in an abducted and relaxed position, after expiration using a Lufkin Executive® tape.

  At baseline, first month and second month (final)

Secondary Outcomes (16)

• Changes in Weight

  At the baseline (0 Month) and 1st month, 2nd month (final)

• Changes in Fat Mass

  At the baseline (0 Month) and 1st month, 2nd month (final)

• Changes in Total Cholesterol

  At the baseline (0 Month) and 1st month, 2nd month (final)

• Changes in Triglycerides

  At the baseline (0 Month) and 1st month, 2nd month (final)

• Changes in High-density lipoprotein (c-HDL)

  At the baseline (0 Month) and 1st month, 2nd month (final)

Study Arms (2)

Nutrigenetic intervention

ACTIVE COMPARATOR

Diagnostic Test: Nutrigenetic diet according the genetic test

Control Intervention

PLACEBO COMPARATOR

Other: Control intervention group

Interventions

Nutrigenetic diet according the genetic test DIAGNOSTIC_TEST

Subjects within the nutrigenetic intervention group will be provided with a dietary plan according to nutrient intake characteristics by alghoritm genetic afinity.

Nutrigenetic intervention

Control intervention group OTHER

Subjects within the control intervention group will be provided with a dietary plan according to general nutrient recommendation by the AHA (American Hearth association) and national cholesterol education program

Control Intervention

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Subjects who agree to participate in the study and all signed informed consent
• Women with a waist circumference ≥ 88 cm and men ≥ 102 cm according to NCEP/ATPIII.

You may not qualify if:

• Currently consuming any of the following drugs: NSAIDs, anticoagulants, hypoglycemic, or hypolipemic drugs
• Diagnosed autoimmune diseases
• Diagnosed cancer
• Pregnancy and breastfeeding
• Subjects who have undergone a dietary intervention at the time or up to 3 months prior
• Subjects who wish to abandon the study

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

University of Guadalajara

Guadalajara, Jalisco, 44280, Mexico

Location

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wendy Campos-Perez, PhD

  University of Guadalajara

  STUDY CHAIR

• Alondra Mora-Jiménez, Graduate

  University of Guadalajara

  STUDY CHAIR

Central Study Contacts

Erika Martinez Lopez, PhD

CONTACT

3310585200; erikamtz27@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized parallel clinical trial

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 26, 2025
• Study Start: March 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)