An interventional study of Nutrigenetic diet according the genetic test and Control intervention group in Abdominal Obesity, sponsored by University of Guadalajara. Not yet recruiting at 1 site in Mexico. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by University of Guadalajara · Not applicable, Interventional, and Treatment
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.
A total of 60 subjects will be invited to enroll in a clinical trial of nutrigenetic or control intervention. Prior to randomization and the start of the intervention, all subjects will be scheduled for a first appointment where their medical history will be taken and a blood sample will be taken for DNA extraction and their genetic profile will be performed (including 21 SNV (single nucleotide variation) involved in cardiometabolic disorders). The assignment to the intervention group will be done through a random permuted block assignment. In the case of the subjects of the nutrigenetic intervention group, with the help of an algorithm designed for the purposes of this study, their genetic profile of the variants of interest will be entered, in order to determine the dietary pattern to which they have the greatest affinity. Once this data is available, they will be given their eating plan. Regarding the control group, the characteristics of their menu will adhere to what is established in a correct diet and the recommendations of the American Heart Association.
This clinical trial will consist in a 8-week intervention with recurrent visits every 4 weeks. Subjects will be required to follow the dietary plan provided in a menu produced and edited by our research group. In every visit, all subjects will undergo a body composition analysis as well as blood tests that include: total cell count, glucose and lipid homeostasis, serum oxidative and antioxidant markers. In total, they will be evaluated anthropometrically and biochemically on 3 occasions, at baseline, 1 month and 2 months (final).
This study proposes three distinct but closely related approaches to gain a better understanding of nutrigenetics and its impact on precision nutrition.
Once the project is finished, new research strategies will be proposed for future studies, seeking to have an evaluation beyond the anthropometric and biochemical, such as microbiota or gene regulation. In addition to this, the application of the knowledge generated in the project to the health care of patients with obesity who may come to our service in the future will be encouraged. Finally, the knowledge generated will be disseminated in our institutional community, which would increase the impact and significance of the project.
In summary, the impact of this study is divided into the following points:
294 studies on the registry are indexed under Obesity, Abdominal; 45 are open to participants now.
This study's planned enrollment of 60 is close to the median of 58 across 234 interventional studies indexed under Obesity, Abdominal.
Browse Obesity, Abdominal studies →University of Guadalajara is the lead sponsor of 95 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Nutrigenetic diet according the genetic test
Other: Control intervention group
Subjects within the nutrigenetic intervention group will be provided with a dietary plan according to nutrient intake characteristics by alghoritm genetic afinity.
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
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.
Time frame: At baseline, first month and second month (final)
Changes in Weight
The weight will be measure in kilograms on InBody 370
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in Fat Mass
The Fat Mass will be measure in kilograms by electrical bioimpedance on InBody 370
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in Total Cholesterol
Will be measure in mg/dL using a dry chemistry system in Vitros 350 equipment.
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in Triglycerides
Will be measure in mg/dL using a dry chemistry system in Vitros 350 equipment.
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in High-density lipoprotein (c-HDL)
Will be measure in mg/dL using a dry chemistry system in Vitros 350 equipment.
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in Low-density lipoprotein (c-LDL)
Will be calculated using Friedewald formula, which uses the parameters of total cholesterol, HDL and VLDL and the result is reported in mg/dL
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum glucose
Will be measure in mg/dL using a dry chemistry system in Vitros 350 equipment.
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum insulin
It be measure by chemiluminescence immunoassay in DiaSorin Liaison equipment
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in homeostatic model assessment - insulin resistance (HOMA-IR)
Serum glucose and Insulin levels were be combined to report HOMA-IR calculated as described by Matthews
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum Oxidized low-density lipoprotein (oxLDL)
Will be measured in pg/dL. Serum oxLDL levels will be quantified according to the supplier's instructions by an enzyme linked immunosorbent assay (ELISA) kit provided by Cell Biolabs, Inc
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum Oxidized high-density lipoprotein (oxHDL)
Will be measured in pg/dL. Serum oxHDL levels will be quantified according to the supplier's instructions by an enzyme linked immunosorbent assay (ELISA) kit provided by Cell Biolabs, Inc
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum Total antioxidant capacity
Will be measure from serum samples using an OxiSelect TAC Assay Kit, (Cell Biolabs) and reported in mM.
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum Lipid peroxidation
Will be measure in μM. Serum lipid peroxidation will be quantified according to the supplier's instructions by Lipid peroxidation assay kit, Oxford Biomedical
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in hsPCR
Serum levels will be measure using an automated biochemical analyzer, Mindray BS-120 chemistry analyzer, from Shenzhen Mindray Bio-Medical Electronics Co.
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in ApoA1
Serum levels will be measure using an automated biochemical analyzer, Mindray BS-120 chemistry analyzer, from Shenzhen Mindray Bio-Medical Electronics Co.
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in ApoB
Serum levels will be measure using an automated biochemical analyzer, Mindray BS-120 chemistry analyzer, from Shenzhen Mindray Bio-Medical Electronics Co.
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Plan to share: No — The individual participant data will not be shared to protect and safeguard the confidentiality data of the participants.
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for Jul 2025, 4 months later.
Of 106 non-industry interventional studies with no phase under Obesity, Abdominal, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's planned 4 months is below that.
Counting every sponsor, half of 116 studies reached it within 16 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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University of Guadalajara