Abstract

Background Gene-based nutrition recommendations have emerged as a strategy for weight management, but their effectiveness over standard advice remains uncertain.

Objective This study evaluated MyGeneMyDiet® recommendations versus standard advice on anthropometry, biochemical markers, and dietary intake in overweight and obese Filipino adults over 12 months.

Methods In this 12-month randomized controlled trial, participants received either MyGeneMyDiet® or standard advice. Both groups underwent regular nutrition counseling during the active phase (months 0–6) before transitioning to free-living conditions (months 6–12). Primary outcomes included weight, BMI, waist circumference, and body fat percentage; secondary outcomes were dietary intake and biochemical markers. Analyses followed an intention-to-treat approach, with paired t-tests for within-group comparisons and ANCOVA for between-group differences. Sensitivity analyses used Last Observation Carried Forward (LOCF) and Inverse Probability of Attrition Weighting (IPAW) to address loss-to-follow-up.

Results Of 136 screened, 52 participants (19–59 years) were enrolled (MyGeneMyDiet®, n = 29; standard recommendation, n = 23), with 27 completing the study (MyGeneMyDiet®, n = 15; standard recommendation, n = 12). Weight changes over 12 months were minimal, with no substantial differences between groups. At month 6, baseline-adjusted analyses showed no meaningful differences in weight (−0.36 kg [95% CI: −1.77, 1.04]), BMI (0.11 kg/m² [−0.51, 0.73]), waist circumference (−0.27 cm [−2.23, 1.69]), or body fat percentage (0.92% [−0.86, 1.05]). These trends persisted on month 12. While both groups reduced dietary intake, the MyGeneMyDiet® group showed greater decreases in total calories (−461 kcal, P = 0.001), protein (−12 g, P = 0.007), carbohydrates (−46 g, P = 0.015), and fat (−22 g, P = 0.014), though between-group differences remained modest.

Conclusions Gene-based and standard weight management advice led to comparable weight and metabolic outcomes over 12 months. While gene-based recommendations influenced dietary intake, these changes did not improve anthropometric or biochemical outcomes.

This trial was registered at clinicaltrials.gov as NCT05098899.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT05098899

Funding Statement

The study was funded by the Department of Budget and Management, Philippines through the Locally Funded Project (LFP).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

FNRI Institutional Ethics Review Committee (FIERC) of DOST-Food and Nutrition Research Institute gave ethical approval for this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Data for this study is available upon request through a data transfer agreement with the Food and Nutrition Research Institute. Interested researchers may contact the corresponding author to initiate the request.

AbbreviationsBMIbody mass indexDNAdeoxyribonucleic acidFCTFood Composition TableFIERCFNRI Institutional Ethics Review CommitteeFNRIFood and Nutrition Research InstituteFTOfat mass and obesity-associated geneHbA1cglycated hemoglobinHPLCHigh-performance liquid chromatographyIPAQ-SFInternational Physical Activity Questionnaire – Short FormIPAWInverse Probability of Attrition WeightingITTIntention-to-Treat analysisLOCFLast Observation Carried ForwardRNDsRegistered Nutritionist-DietitiansSDstandard deviationSNOSEsequentially numbered, opaque sealed envelopesTCF7L2transcription factor 7-like 2 geneUCP1uncoupling protein 1 geneWHOWorld Health Organization