NCT05495074

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

3.4 years

First QC Date

August 8, 2022

Last Update Submit

March 9, 2026

Conditions

Metabolic Syndrome

Keywords

Genetic scoreAmino acids metabolismATPIII

Outcome Measures

Primary Outcomes (5)

  • Change in waist circumference

    Change in waist circumference before and after the dietary intervention (cm)

    Baseline to 2-month

  • Change in serum glucose

    The concentration of serum glucose will be determined by an autoanalyzer before and after the intervention

    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)

    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)

    Baseline to 2-month

  • Change in systolic and diastolic blood pressure

    The blood pressure will be determined before and after the intervention (mmHg)

    Baseline to 2-month

Secondary Outcomes (9)

  • Change in the serum amino acid profile

    Baseline to 2-month

  • Change in body composition

    Baseline to 2-month

  • Change in body weight

    Baseline to 2-month

  • Change in serum insulin

    Baseline to 2-month

  • Change in serum leptin

    Baseline to 2-month

  • +4 more secondary outcomes

Study Arms (1)

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.

Other: ATP III dietary intervention

Interventions

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.

Dietary Intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Adults with any catabolic diseases such as cancer and/or AIDS.
  • Gravidity status
  • Adults who smoke
  • Adults in treatment with any medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran.

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (5)

  • 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.

    PMID: 21423183BACKGROUND

  • Kettunen 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

  • Mahendran 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.

    PMID: 28184960BACKGROUND

  • Serralde-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

  • Teslovich 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.

    BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 10, 2022

Study Start

August 2, 2021

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)