Abdominal ObesityINNUPRECNCT06847243
INNUPREC (Nutrigenetic Intervention for the Prevention of Cardiovascular Disease)
A study testing Nutrigenetic diet according the genetic test in people with Abdominal Obesity, run by University of Guadalajara at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- Nutrigenetic diet according the genetic test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
University of Guadalajara
Guadalajara, Jalisco, 44280
ERIKA MARTINEZ LOPEZ, PhD, +52(33)10585200 ext. 33644, erikamtz27@yahoo.com.mx
Wendy Campos-Perez, PhD, +523315720873, wendy.campos4381@academicos.udg.mx
About this study
Official title: Effect of Nutrigenetic Intervention on Cardiovascular Biomarkers, Oxidative Stress and Antioxidant Capacity in Subjects with Abdominal Obesity
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.
Read the detailed description
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.
- To compare the effect and impact of personalized nutritional interventions on nutritional diets with general recommendations.
- See the impact of a personalized diet in improving parameters involved in the development of cardiovascular diseases
- Develop new personalized nutritional treatment strategies for subjects with chronic diseases
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:
- Design of new strategys as nutrigenetic intervention´s for the treatment and prevention metabolic disease such as obesity and cardiovascular
- Identification of some cardiovascular biomarkers relevant to the treatment of abdominal obesity and its comorbidities
- Useful information on gene-nutrient interaction for the public and private sector in the field of genetic testing
- Study population benefited from the results of the intervention and the information of their genetic and biochemical profiles
- Conditions
- Abdominal Obesity
- Being tested
- Nutrigenetic diet according the genetic test, Control intervention group
- Keywords
- Abdominal obesity, Nutrigenetic intervention, Cardiometabolic biomarkers
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrigenetic diet according the genetic testDiagnostic test
Subjects within the nutrigenetic intervention group will be provided with a dietary plan according to nutrient intake characteristics by alghoritm genetic afinity.
Control intervention groupOther
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
| Study group | Role | What they receive |
|---|---|---|
| Nutrigenetic intervention | Active comparator | Not described Receives: Diagnostic Test: Nutrigenetic diet according the genetic test |
| Control Intervention | Placebo comparator | Not described Receives: Other: Control intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, first month and second month (final)
Secondary outcomes (16)
Changes in Weight
The weight will be measure in kilograms on InBody 370
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the baseline (0 Month) and 1st month, 2nd month (final)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERIKA MARTINEZ-LOPEZ, University of Guadalajara
- Investigators
- Wendy Campos-Perez, PhD, Study chair, University of GuadalajaraAlondra Mora-Jiménez, Graduate, Study chair, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847243
- Sponsor's protocol ID
- CI-05223
- Acronym
- INNUPREC
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared to protect and safeguard the confidentiality data of the participants.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutrigenetic Intervention on Cardiovascular Biomarkers, Oxidative Stress and Antioxidant Capacity in Subjects with Abdominal Obesity
- ClinicalTrials.gov ID
- NCT06847243
- Acronym / sponsor ID
- INNUPREC / CI-05223
- Conditions
- Abdominal Obesity
- Keywords
- Abdominal obesity, Nutrigenetic intervention, Cardiometabolic biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- To compare the effect and impact of personalized nutritional interventions on nutritional diets with general recommendations.
- See the impact of a personalized diet in improving parameters involved in the development of cardiovascular diseases
- Develop new personalized nutritional treatment strategies for subjects with chronic diseases
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:
- Design of new strategys as nutrigenetic intervention´s for the treatment and prevention metabolic disease such as obesity and cardiovascular
- Identification of some cardiovascular biomarkers relevant to the treatment of abdominal obesity and its comorbidities
- Useful information on gene-nutrient interaction for the public and private sector in the field of genetic testing
- Study population benefited from the results of the intervention and the information of their genetic and biochemical profiles
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| Nutrigenetic intervention | Active comparator | Diagnostic Test: Nutrigenetic diet according the genetic test |
| Control Intervention | Placebo comparator | Other: Control intervention group |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrigenetic diet according the genetic testSubjects within the nutrigenetic intervention group will be provided with a dietary plan according to nutrient intake characteristics by alghoritm genetic afinity. | Diagnostic test | Nutrigenetic intervention |
| Control intervention groupSubjects 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 | Other | Control Intervention |
Primary outcome
Changes in Waist Circumference between nutrigenetic and control group
Time frame: At baseline, first month and second month (final)
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.
16 secondary outcomes
Changes in Weight
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in Fat Mass
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in Total Cholesterol
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in Triglycerides
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in High-density lipoprotein (c-HDL)
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in Low-density lipoprotein (c-LDL)
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum glucose
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum insulin
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in homeostatic model assessment - insulin resistance (HOMA-IR)
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum Oxidized low-density lipoprotein (oxLDL)
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum Oxidized high-density lipoprotein (oxHDL)
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum Total antioxidant capacity
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in serum Lipid peroxidation
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in hsPCR
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in ApoA1
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Changes in ApoB
Time frame: At the baseline (0 Month) and 1st month, 2nd month (final)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No. The individual participant data will not be shared to protect and safeguard the confidentiality data of the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wendy Campos-Perez, PhD study chair
University of Guadalajara
Alondra Mora-Jiménez, Graduate study chair
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrigenetic diet according the genetic test in people with Abdominal Obesity, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erika Martinez Lopez, PhD (3310585200 ext. 33644, erikamtz27@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Waist Circumference between nutrigenetic and control group (time frame: At baseline, first month and second month (final)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.