Metabolic SyndromeNCT05495074
Design of a Genetic Score to Predict the Response to a Dietary Intervention in Adults With Metabolic Syndrome
A study testing ATP III dietary intervention in people with Metabolic Syndrome, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
The aim of this study is to evaluate whether a genetic score based on genetic variants related to amino acid metabolism could predict the response to a dietary intervention in adults with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- ATP III dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteMexico
- Study dates
- 2 Aug 2021to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults (men and women) between the ages of 18 and 60.
- Adults mexican mestizos (parents and grandparents born in Mexico).
- Adults who can read and write.
- Adults willing/able to provide informed consent.
- Adults with obesity (BMI ≥ 30 and ≤ 39 kg / m2).
- Adults with at least one of the metabolic syndrome diagnostic criteria:
- Waist circumference: men > 102 cm or women > 88 cm. Hypertriglyceridemia >150 mg/dL High fasting glucose >100 mg/dL High blood pressure ≥ 130/85 mmHg Low HDL-cholesterol: men <40 mg/dL and women < 50 mg/dL
Who cannot join
- Adults with any type of diabetes.
- Adults with hypertension.
- Adults with kidney disease diagnosed by a medical or with creatinine> 1.3 mg / dL for men and > 1.1 mg / dL for women and / or blood urea nitrogen (BUN)> 20 mg / dL.
- Adults with acquired diseases that produce obesity and diabetes secondarily.
- Adults who have suffered a cardiovascular event.
- Adults with weight loss > 3 kg in the last 3 months.
Show all 10Show fewer
- Adults with any catabolic diseases such as cancer and/or AIDS.
- Gravidity status
- Adults who smoke
- Adults in treatment with any medication
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran.
Mexico City, Mexico City, 14080
About this study
The aim of this study is to evaluate whether a genetic score based on genetic variants related to amino acid metabolism could predict the response to a dietary intervention in adults with metabolic syndrome.
Read the detailed description
Metabolic syndrome (MetS) results from the interaction between genetic and environmental factors. Single nucleotide polymorphisms (SNPs) are within the genetic factors. Various SNPs influence amino acid metabolism, and therefore their plasma concentrations. For example, the presence of SNPs such as rs10211524 (SLC1A4), rs9637599 (PPM1K), rs7406661 (ASGR), rs4788815 (TAT), rs199999090, rs11548193 (BCAT2), and rs45500792 (BCKDH), among others, have been related to alterations in the plasma concentration of amino acids. High plasma concentration of amino acids, specifically of branched chain amino acids (BCAA), have a positive association with the presence of different risk factors for MetS including waist circumference, dyslipidemia, blood pressure, glucose concentration and insulin resistance (IR). Moreover, subjects with MetS have a plasma BCAA concentration of up to 34% higher than subjects without MetS.
In the other hand, dietary interventions are among the environmental factors that can prevent MetS. For example, the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) in the United States recommends a low saturated fat diet (LSFD) to reduce LDL cholesterol. Although, this recommendation has been suggested to attenuate some of the metabolic abnormalities in individuals with MetS, there is no biological marker that can identify individuals who will respond to a LSFD. Notably, the presence of SNPs could help to identify those individuals. The clinical effects exhibited by SNPs when analyzed individually are generally small. For this reason, it has been sought to evaluate the contributory effects of multiple SNPs by means of a genetic score. The construction of a genetic score could capture the complex relationship between MetS, genetics, and dietary interventions, providing us with a greater understanding of the biochemical and metabolic alterations and responses to available treatments. Furthermore, a genetic score could have a therapeutic value in predicting the response to a dietary intervention in subjects with risk factors for MetS. Predicting the response to a dietary intervention may help implement individualized diets based on the genetic predisposition and clinical characteristics of each individual, showing beneficial effects on anthropometric, clinical and biochemical markers. Likewise, implementing dietary interventions for preventive purposes for complex diseases could minimize public health expenditures.
Adults will be invited to participate through advertising distributed in the City of San Luis Potosí, Mexico. Those interested in participating will be given a short telephone interview to verify that they meet the selection criteria. Then, an appointment will be scheduled to go to the Faculty of Chemical Sciences of the Autonomous University of San Luis Potosí (UASLP). During this visit, participants will be informed of the characteristics of the study, the risks and the benefits expected after the dietary intervention. Those who accept to participate will sign the consent letter. Then a clinical a nutritional assessment will be performed. A blood sample and blood pressure will be taken by a specialist. Anthropometric and body composition measurements will be made. An history of food consumption frequency will be obtained by a nutritionist. The physical activity questionnaire will be carried out (IPAQ long version). The patient will be advised not to change the level of habitual physical activity. Participants will be then assigned a diet for two months following the indications of the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) program. The follow-up of the diet will be evaluated by telephone by a nutritionist who will carry out 24-hour reminder questionnaires randomly every 15 days to each participant. After the first visit, participants will start consuming the diet corresponding to their group. The different menus will be delivered and explained to them. A food guide will be given so that they have food exchange options. Patients will be taught to fill the feed log and will be cited in two months.
During the second visit, the investigators will collect a 24-hour dietary record, food logs and the investigators will perform a second clinical and nutritional assessment, including the determination of anthropometric measurements such as weight, waist circumference and body composition, whole blood sample and blood pressure will be taken. The physical activity questionnaire will be carried out (IPAQ long version). Finally, participants will be scheduled within fifteen days for delivery of results and to explain the actions that will be carried out at the end of the study to maintain the continuity of the treatment.
- Conditions
- Metabolic Syndrome
- Being tested
- ATP III dietary intervention
- Keywords
- Genetic score, Amino acids metabolism, ATPIII
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATP III dietary interventionOther
The dietary intervention will consist of an approximate decrease of 500 kcal from the calories participants habitually consume, with the following macronutrient distribution 15-20% protein, 50-60% carbohydrates, 25-35% fat. Participants will receive recipes with menus for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention | Experimental | Participants will be assigned a diet for two months following the indications of the National Cholesterol Education Program Adult Treatment Panel III program. Receives: Other: ATP III dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in waist circumference
Change in waist circumference before and after the dietary intervention (cm)
Measured: Baseline to 2-month
Change in serum glucose
The concentration of serum glucose will be determined by an autoanalyzer before and after the intervention
Measured: Baseline to 2-month
Change in serum HDL cholesterol
The concentration of serum HDL-cholesterol will be determined by an autoanalyzer before and after the intervention (mg/dL)
Measured: Baseline to 2-month
Change in serum triglycerides
The concentration of serum triglycerides will be determined by an autoanalyzer before and after the intervention (mg/dL)
Measured: Baseline to 2-month
Change in systolic and diastolic blood pressure
The blood pressure will be determined before and after the intervention (mmHg)
Measured: Baseline to 2-month
Secondary outcomes (9)
Change in the serum amino acid profile
The concentration of the amino acid profile will be determined by high pressure liquid chromatography (HPLC) before and after the dietary intervention
Measured: Baseline to 2-month
Change in body composition
Change in the percentage of fat mass, lean mass and skeletal muscle mass before and after the dietary intervention.
Measured: Baseline to 2-month
Change in body weight
The change in body weight before and after the dietary intervention.
Measured: Baseline to 2-month
Change in serum insulin
The concentration of insulin will be determined by ELISA before and after the dietary intervention
Measured: Baseline to 2-month
Change in serum leptin
The concentration of leptin will be determined by ELISA before and after the dietary intervention
Measured: Baseline to 2-month
Change in serum glucagon
The concentration of glucagon will be determined by ELISA before and after the dietary intervention
Measured: Baseline to 2-month
Change in serum adiponectin
The concentration of adiponectin will be determined by ELISA before and after the dietary intervention
Measured: Baseline to 2-month
Change of insulin resistance by homeostasis model assessment (HOMA) index
The HOMA index will be calculated as follows: glucose (mg / dl) x insulin (mUI / ml) / 405 before and after the dietary intervention
Measured: Baseline to 2-month
Change of Body mass index
The body mass index will be calculated before an after the dietary intervention.
Measured: Baseline to 2-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start2 Aug 2021
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma de San Luis Potosí
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495074
- Sponsor's protocol ID
- FNU-3813-21-22-1
- Status last verified
- Mar 2026
- First submitted
- 8 Aug 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang TJ, Larson MG, Vasan RS, Cheng S, Rhee EP, McCabe E, Lewis GD, Fox CS, Jacques PF, Fernandez C, O'Donnell CJ, Carr SA, Mootha VK, Florez JC, Souza A, Melander O, Clish CB, Gerszten RE. Metabolite profiles and the risk of developing diabetes. Nat Med. 2011 Apr;17(4):448-53. doi: 10.1038/nm.2307. Epub 2011 Mar 20.
PubMed 21423183Kettunen J, Tukiainen T, Sarin AP, Ortega-Alonso A, Tikkanen E, Lyytikainen LP, Kangas AJ, Soininen P, Wurtz P, Silander K, Dick DM, Rose RJ, Savolainen MJ, Viikari J, Kahonen M, Lehtimaki T, Pietilainen KH, Inouye M, McCarthy MI, Jula A, Eriksson J, Raitakari OT, Salomaa V, Kaprio J, Jarvelin MR, Peltonen L, Perola M, Freimer NB, Ala-Korpela M, Palotie A, Ripatti S. Genome-wide association study identifies multiple loci influencing human serum metabolite levels. Nat Genet. 2012 Jan 29;44(3):269-76. doi: 10.1038/ng.1073.
PubMed 22286219Mahendran Y, Jonsson A, Have CT, Allin KH, Witte DR, Jorgensen ME, Grarup N, Pedersen O, Kilpelainen TO, Hansen T. Genetic evidence of a causal effect of insulin resistance on branched-chain amino acid levels. Diabetologia. 2017 May;60(5):873-878. doi: 10.1007/s00125-017-4222-6. Epub 2017 Feb 10.
PubMed 28184960Serralde-Zuniga AE, Guevara-Cruz M, Tovar AR, Herrera-Hernandez MF, Noriega LG, Granados O, Torres N. Omental adipose tissue gene expression, gene variants, branched-chain amino acids, and their relationship with metabolic syndrome and insulin resistance in humans. Genes Nutr. 2014 Nov;9(6):431. doi: 10.1007/s12263-014-0431-5. Epub 2014 Sep 27.
PubMed 25260659Teslovich TM, Kim DS, Yin X, Stancakova A, Jackson AU, Wielscher M, Naj A, Perry JRB, Huyghe JR, Stringham HM, Davis JP, Raulerson CK, Welch RP, Fuchsberger C, Locke AE, Sim X, Chines PS, Narisu N, Kangas AJ, Soininen P; Genetics of Obesity-Related Liver Disease Consortium (GOLD), The Alzheimer's Disease Genetics Consortium (ADGC), The DIAbetes Genetics Replication And Meta-analysis (DIAGRAM); Ala-Korpela M, Gudnason V, Musani SK, Jarvelin MR, Schellenberg GD, Speliotes EK, Kuusisto J, Collins FS, Boehnke M, Laakso M, Mohlke KL. Identification of seven novel loci associated with amino acid levels using single-variant and gene-based tests in 8545 Finnish men from the METSIM study. Hum Mol Genet. 2018 May 1;27(9):1664-1674. doi: 10.1093/hmg/ddy067.
PubMed 29481666
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Genetic Score to Predict the Response to a Dietary Intervention in Adults With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT05495074
- Acronym / sponsor ID
- FNU-3813-21-22-1
- Conditions
- Metabolic Syndrome
- Keywords
- Genetic score, Amino acids metabolism, ATPIII
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- Universidad Autonoma de San Luis Potosí
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 10 Aug 2022 (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.
The aim of this study is to evaluate whether a genetic score based on genetic variants related to amino acid metabolism could predict the response to a dietary intervention in adults with metabolic syndrome.
Detailed description
Metabolic syndrome (MetS) results from the interaction between genetic and environmental factors. Single nucleotide polymorphisms (SNPs) are within the genetic factors. Various SNPs influence amino acid metabolism, and therefore their plasma concentrations. For example, the presence of SNPs such as rs10211524 (SLC1A4), rs9637599 (PPM1K), rs7406661 (ASGR), rs4788815 (TAT), rs199999090, rs11548193 (BCAT2), and rs45500792 (BCKDH), among others, have been related to alterations in the plasma concentration of amino acids. High plasma concentration of amino acids, specifically of branched chain amino acids (BCAA), have a positive association with the presence of different risk factors for MetS including waist circumference, dyslipidemia, blood pressure, glucose concentration and insulin resistance (IR). Moreover, subjects with MetS have a plasma BCAA concentration of up to 34% higher than subjects without MetS.
In the other hand, dietary interventions are among the environmental factors that can prevent MetS. For example, the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) in the United States recommends a low saturated fat diet (LSFD) to reduce LDL cholesterol. Although, this recommendation has been suggested to attenuate some of the metabolic abnormalities in individuals with MetS, there is no biological marker that can identify individuals who will respond to a LSFD. Notably, the presence of SNPs could help to identify those individuals. The clinical effects exhibited by SNPs when analyzed individually are generally small. For this reason, it has been sought to evaluate the contributory effects of multiple SNPs by means of a genetic score. The construction of a genetic score could capture the complex relationship between MetS, genetics, and dietary interventions, providing us with a greater understanding of the biochemical and metabolic alterations and responses to available treatments. Furthermore, a genetic score could have a therapeutic value in predicting the response to a dietary intervention in subjects with risk factors for MetS. Predicting the response to a dietary intervention may help implement individualized diets based on the genetic predisposition and clinical characteristics of each individual, showing beneficial effects on anthropometric, clinical and biochemical markers. Likewise, implementing dietary interventions for preventive purposes for complex diseases could minimize public health expenditures.
Adults will be invited to participate through advertising distributed in the City of San Luis Potosí, Mexico. Those interested in participating will be given a short telephone interview to verify that they meet the selection criteria. Then, an appointment will be scheduled to go to the Faculty of Chemical Sciences of the Autonomous University of San Luis Potosí (UASLP). During this visit, participants will be informed of the characteristics of the study, the risks and the benefits expected after the dietary intervention. Those who accept to participate will sign the consent letter. Then a clinical a nutritional assessment will be performed. A blood sample and blood pressure will be taken by a specialist. Anthropometric and body composition measurements will be made. An history of food consumption frequency will be obtained by a nutritionist. The physical activity questionnaire will be carried out (IPAQ long version). The patient will be advised not to change the level of habitual physical activity. Participants will be then assigned a diet for two months following the indications of the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) program. The follow-up of the diet will be evaluated by telephone by a nutritionist who will carry out 24-hour reminder questionnaires randomly every 15 days to each participant. After the first visit, participants will start consuming the diet corresponding to their group. The different menus will be delivered and explained to them. A food guide will be given so that they have food exchange options. Patients will be taught to fill the feed log and will be cited in two months.
During the second visit, the investigators will collect a 24-hour dietary record, food logs and the investigators will perform a second clinical and nutritional assessment, including the determination of anthropometric measurements such as weight, waist circumference and body composition, whole blood sample and blood pressure will be taken. The physical activity questionnaire will be carried out (IPAQ long version). Finally, participants will be scheduled within fifteen days for delivery of results and to explain the actions that will be carried out at the end of the study to maintain the continuity of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention | Experimental | Other: ATP III dietary interventionParticipants will be assigned a diet for two months following the indications of the National Cholesterol Education Program Adult Treatment Panel III program. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults (men and women) between the ages of 18 and 60.
- Adults mexican mestizos (parents and grandparents born in Mexico).
- Adults who can read and write.
- Adults willing/able to provide informed consent.
- Adults with obesity (BMI ≥ 30 and ≤ 39 kg / m2).
Key exclusion criteria (10 listed)
- Adults with any type of diabetes.
- Adults with hypertension.
- Adults with kidney disease diagnosed by a medical or with creatinine> 1.3 mg / dL for men and > 1.1 mg / dL for women and / or blood urea nitrogen (BUN)> 20 mg / dL.
- Adults with acquired diseases that produce obesity and diabetes secondarily.
- Adults who have suffered a cardiovascular event.
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 |
|---|---|---|
| ATP III dietary interventionThe dietary intervention will consist of an approximate decrease of 500 kcal from the calories participants habitually consume, with the following macronutrient distribution 15-20% protein, 50-60% carbohydrates, 25-35% fat. Participants will receive recipes with menus for two weeks. | Other | Dietary Intervention |
Primary outcome
Change in waist circumference
Time frame: Baseline to 2-month
Change in waist circumference before and after the dietary intervention (cm)
Change in serum glucose
Time frame: Baseline to 2-month
The concentration of serum glucose will be determined by an autoanalyzer before and after the intervention
Change in serum HDL cholesterol
Time frame: Baseline to 2-month
The concentration of serum HDL-cholesterol will be determined by an autoanalyzer before and after the intervention (mg/dL)
Change in serum triglycerides
Time frame: Baseline to 2-month
The concentration of serum triglycerides will be determined by an autoanalyzer before and after the intervention (mg/dL)
Change in systolic and diastolic blood pressure
Time frame: Baseline to 2-month
The blood pressure will be determined before and after the intervention (mmHg)
9 secondary outcomes
Change in the serum amino acid profile
Time frame: Baseline to 2-month
Change in body composition
Time frame: Baseline to 2-month
Change in body weight
Time frame: Baseline to 2-month
Change in serum insulin
Time frame: Baseline to 2-month
Change in serum leptin
Time frame: Baseline to 2-month
Change in serum glucagon
Time frame: Baseline to 2-month
Change in serum adiponectin
Time frame: Baseline to 2-month
Change of insulin resistance by homeostasis model assessment (HOMA) index
Time frame: Baseline to 2-month
Change of Body mass index
Time frame: Baseline to 2-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Background: PubMed 21423183Wang TJ, Larson MG, Vasan RS, Cheng S, Rhee EP, McCabe E, Lewis GD, Fox CS, Jacques PF, Fernandez C, O'Donnell CJ, Carr SA, Mootha VK, Florez JC, Souza A, Melander O, Clish CB, Gerszten RE. Metabolite profiles and the risk of developing diabetes. Nat Med. 2011 Apr;17(4):448-53. doi: 10.1038/nm.2307. Epub 2011 Mar 20.
- Background: PubMed 22286219Kettunen J, Tukiainen T, Sarin AP, Ortega-Alonso A, Tikkanen E, Lyytikainen LP, Kangas AJ, Soininen P, Wurtz P, Silander K, Dick DM, Rose RJ, Savolainen MJ, Viikari J, Kahonen M, Lehtimaki T, Pietilainen KH, Inouye M, McCarthy MI, Jula A, Eriksson J, Raitakari OT, Salomaa V, Kaprio J, Jarvelin MR, Peltonen L, Perola M, Freimer NB, Ala-Korpela M, Palotie A, Ripatti S. Genome-wide association study identifies multiple loci influencing human serum metabolite levels. Nat Genet. 2012 Jan 29;44(3):269-76. doi: 10.1038/ng.1073.
- Background: PubMed 28184960Mahendran Y, Jonsson A, Have CT, Allin KH, Witte DR, Jorgensen ME, Grarup N, Pedersen O, Kilpelainen TO, Hansen T. Genetic evidence of a causal effect of insulin resistance on branched-chain amino acid levels. Diabetologia. 2017 May;60(5):873-878. doi: 10.1007/s00125-017-4222-6. Epub 2017 Feb 10.
- Background: PubMed 25260659Serralde-Zuniga AE, Guevara-Cruz M, Tovar AR, Herrera-Hernandez MF, Noriega LG, Granados O, Torres N. Omental adipose tissue gene expression, gene variants, branched-chain amino acids, and their relationship with metabolic syndrome and insulin resistance in humans. Genes Nutr. 2014 Nov;9(6):431. doi: 10.1007/s12263-014-0431-5. Epub 2014 Sep 27.
- Background: PubMed 29481666Teslovich TM, Kim DS, Yin X, Stancakova A, Jackson AU, Wielscher M, Naj A, Perry JRB, Huyghe JR, Stringham HM, Davis JP, Raulerson CK, Welch RP, Fuchsberger C, Locke AE, Sim X, Chines PS, Narisu N, Kangas AJ, Soininen P; Genetics of Obesity-Related Liver Disease Consortium (GOLD), The Alzheimer's Disease Genetics Consortium (ADGC), The DIAbetes Genetics Replication And Meta-analysis (DIAGRAM); Ala-Korpela M, Gudnason V, Musani SK, Jarvelin MR, Schellenberg GD, Speliotes EK, Kuusisto J, Collins FS, Boehnke M, Laakso M, Mohlke KL. Identification of seven novel loci associated with amino acid levels using single-variant and gene-based tests in 8545 Finnish men from the METSIM study. Hum Mol Genet. 2018 May 1;27(9):1664-1674. doi: 10.1093/hmg/ddy067.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATP III dietary intervention in people with Metabolic Syndrome, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 11 Mar 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in waist circumference (time frame: Baseline to 2-month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495074, which also lists 5 linked publications.
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 11 Mar 2026.