NCT06847243Not yet recruiting
INNUPREC (Nutrigenetic Intervention for the Prevention of Cardiovascular Disease)
Effect of Nutrigenetic Intervention on Cardiovascular Biomarkers, Oxidative Stress and Antioxidant Capacity in Subjects with Abdominal Obesity
Source: ClinicalTrials.gov · Last updated 3 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 10 Feb 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- University of Guadalajara
- Diseases
- Obesity
- NCT number
- NCT06847243
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Mar 2025 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently consuming any of the following drugs: NSAIDs, anticoagulants, hypoglycemic, or hypolipemic drugs
- Subjects who have undergone a dietary intervention at the time or up to 3 months prior
Other illness
- Diagnosed autoimmune diseases
- Diagnosed cancer
Other
- Pregnancy and breastfeeding
- Subjects who wish to abandon the study
Who the study is looking for
- 30-65 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.
Age in the registry: 30 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Guadalajara Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.