Overweight and ObesityNCT05098899
MyGeneMyDiet Trial for Weight Management
A study testing MyGeneMyDiet® Recommendations for Weight Management in people with Overweight and Obesity, run by Food and Nutrition Research Institute, Philippines at 1 site in Philippines.
Trial summary
The study aims to determine if genotype-based nutrition and lifestyle advice is effective for the management of overweight and obesity among Filipino adults compared to the usual standard of care. Read more about this study
- Who is it for?
- Ages 19 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- MyGeneMyDiet® Recommendations for Weight Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Dec 2021to 31 Aug 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 19 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight or obese Filipino adults who signify a willingness to participate in the study
- With BMI equal to 25.0 but not more than 40 kg/m2
- Apparently healthy (fasting blood glucose, lipid profile, and blood pressure within the normal range to pre-disease state)
- Normal thyroid hormone levels in the blood
- Normal blood cortisol level
- Carriers of at least one of the risk alleles of FTO rs9939609, UCP1 rs1800592, and TCF7L2 rs7903146
Who cannot join
- Elevated levels of fasting blood glucose, blood lipids, and blood pressure
- Elevated levels of thyroid hormones, and cortisol level
- Self-reported/history of heart disease
- Participation in a weight loss program or adherence to restrictive /therapeutic diet in the past 3 month
- Self-reported of recent weight changes greater or less than 3.0 kg
- Planned or recent bariatric surgery
Show all 11Show fewer
- Consumption of weight-altering medications and/or nutritional supplements that promote weight gain/loss in the past 6 months
- Clinical diagnosis of any mental disorder and current use of any mental health medications
- Pregnant, nursing, or with self-declared intention to become pregnant
- Any health condition that may put the participant at risk
- Current and anticipated enrolment in another research study during the course of the trial
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Department of Science and Technology-Food and Nutrition Research Institute
City of Taguig, National Capital Region, 1631
About this study
Official title: Interventions Using Genomics-based Strategies (InGeSt) Towards Enhanced Nutrition Recommendations: A Proof-of-concept RCT for the DNA-based Nutrition and Lifestyle Recommendations in Overweight and Obese Filipino Adults
The study aims to determine if genotype-based nutrition and lifestyle advice is effective for the management of overweight and obesity among Filipino adults compared to the usual standard of care.
Read the detailed description
The primary objective of the study is to determine if providing a nutrition and lifestyle advice with genetic information can promote the attainment of 5-10% weight loss, and improvements on body mass index, waist circumference, and body fat percentage among Filipino adults with overweight and obesity. Additionally, changes in dietary intake, eating behaviour, physical activity level, biochemical parameters (HbA1c and blood lipid profile), motivation for weight loss, and knowledge and perceptions on nutrigenomics and genetic testing will also be assessed.
- Conditions
- Overweight and Obesity
- Being tested
- MyGeneMyDiet® Recommendations for Weight Management, Usual Standard of Care for Weight Management
- Keywords
- Overweight, Obesity, Nutritional Genomics, Nutrigenomics, DNA-based nutrition advice, Genotype-based nutrition advice
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyGeneMyDiet® Recommendations for Weight ManagementGenetic
This group will receive Nutrition and Lifestyle recommendation based on SNPs known to have an impact to body weight and body composition, and responses to physical activity and dietary fat intake
Usual Standard of Care for Weight ManagementOther
This group will receive the conventional and standard nutrition lifestyle recommendation for weight management
| Study group | Role | What they receive |
|---|---|---|
| MyGeneMyDiet® Recommendations for Weight Management | Experimental | A set of nutrition and lifestyle advice for weight management derived from genetic information Receives: Genetic: MyGeneMyDiet® Recommendations for Weight Management |
| Usual Standard of Care for Weight Management | Active comparator | A set of standard nutrition and lifestyle advice for weight management without genetic information Receives: Other: Usual Standard of Care for Weight Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
5% weight loss
Attainment of 5% weight loss
Measured: 24 weeks
10% weight loss
Attainment of 10% weight loss
Measured: 48 weeks
Body mass index
Changes in BMI
Measured: 24 weeks
Waist circumference
Changes in waist circumference
Measured: 24 weeks
Body fat percentage
Changes in body fat percentage
Measured: 24 weeks
Secondary outcomes (7)
Dietary intake
Improvements in dietary intake
Measured: 24 weeks
Eating behavior
Improvements in eating behavior
Measured: 24 weeks
Physical activity level
Improvements in physical activity level
Measured: 24 weeks
Glycated haemoglobin (HbA1c)
Changes in HbA1c
Measured: 24 weeks
Blood lipid profile (TC, LDL-C, HDL-C, Triglycerides)
Changes in TC, LDL-C, HDL-C, Triglycerides
Measured: 24 weeks
Motivation for weight loss
Stages and motivation for weight loss
Measured: 24 weeks
Knowledge and perceptions
Knowledge and perceptions in nutrigenomics and genetic testing
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Dec 2021
- Primary completion30 May 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Food and Nutrition Research Institute, Philippines
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jacus Nacis, Food and Nutrition Research Institute, Philippines
- Investigators
- Jacus S Nacis, MBAH, Principal investigator, Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098899
- Sponsor's protocol ID
- 19-003-00-00000-2-12-6-2021
- Status last verified
- Sep 2024
- First submitted
- 20 Oct 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nacis JS, Labrador JPH, Ronquillo DGD, Rodriguez MP, Dablo AMFD, Frane RD, Madrid ML, Santos NLC, Carrillo JJV, Fernandez MG, Gonzales GBL. A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet(R) study. Front Nutr. 2023 Aug 22;10:1238234. doi: 10.3389/fnut.2023.1238234. eCollection 2023.
PubMed 37674889Nacis J, Labrador JP, Ronquillo DG, Rementilla JC, Rodriguez M, Madrid M, Frane R, Santos NL, Dablo AMF, Carrillo JJ, Fernandez MG, Fanio DJ, Martirez DA, Paller M, Monje HS, Cabigan RM, Bausas AA, Agra GM, Bunhiyan R, van Duijnhoven FJB, Gonzales GB. Effect of gene-based vs. standard weight-loss recommendations on anthropometry, lipid and glucose markers, and dietary intake: a randomized controlled trial (the MyGeneMyDiet(R) Study). Genes Nutr. 2026 Feb 7;21(1):4. doi: 10.1186/s12263-026-00794-z.
PubMed 41654718
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions Using Genomics-based Strategies (InGeSt) Towards Enhanced Nutrition Recommendations: A Proof-of-concept RCT for the DNA-based Nutrition and Lifestyle Recommendations in Overweight and Obese Filipino Adults
- ClinicalTrials.gov ID
- NCT05098899
- Acronym / sponsor ID
- 19-003-00-00000-2-12-6-2021
- Conditions
- Overweight and Obesity
- Keywords
- Overweight, Obesity, Nutritional Genomics, Nutrigenomics, DNA-based nutrition advice, Genotype-based nutrition advice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Food and Nutrition Research Institute, PhilippinesOther government
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 28 Oct 2021 (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 study aims to determine if genotype-based nutrition and lifestyle advice is effective for the management of overweight and obesity among Filipino adults compared to the usual standard of care.
Detailed description
The primary objective of the study is to determine if providing a nutrition and lifestyle advice with genetic information can promote the attainment of 5-10% weight loss, and improvements on body mass index, waist circumference, and body fat percentage among Filipino adults with overweight and obesity. Additionally, changes in dietary intake, eating behaviour, physical activity level, biochemical parameters (HbA1c and blood lipid profile), motivation for weight loss, and knowledge and perceptions on nutrigenomics and genetic testing will also be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyGeneMyDiet® Recommendations for Weight Management | Experimental | Genetic: MyGeneMyDiet® Recommendations for Weight ManagementA set of nutrition and lifestyle advice for weight management derived from genetic information |
| Usual Standard of Care for Weight Management | Active comparator | Other: Usual Standard of Care for Weight ManagementA set of standard nutrition and lifestyle advice for weight management without genetic information |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Overweight or obese Filipino adults who signify a willingness to participate in the study
- With BMI equal to 25.0 but not more than 40 kg/m2
- Apparently healthy (fasting blood glucose, lipid profile, and blood pressure within the normal range to pre-disease state)
- Normal thyroid hormone levels in the blood
- Normal blood cortisol level
Key exclusion criteria (11 listed)
- Elevated levels of fasting blood glucose, blood lipids, and blood pressure
- Elevated levels of thyroid hormones, and cortisol level
- Self-reported/history of heart disease
- Participation in a weight loss program or adherence to restrictive /therapeutic diet in the past 3 month
- Self-reported of recent weight changes greater or less than 3.0 kg
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 |
|---|---|---|
| MyGeneMyDiet® Recommendations for Weight ManagementThis group will receive Nutrition and Lifestyle recommendation based on SNPs known to have an impact to body weight and body composition, and responses to physical activity and dietary fat intake | Genetic | MyGeneMyDiet® Recommendations for Weight Management |
| Usual Standard of Care for Weight ManagementThis group will receive the conventional and standard nutrition lifestyle recommendation for weight management | Other | Usual Standard of Care for Weight Management |
Primary outcome
5% weight loss
Time frame: 24 weeks
Attainment of 5% weight loss
10% weight loss
Time frame: 48 weeks
Attainment of 10% weight loss
Body mass index
Time frame: 24 weeks
Changes in BMI
Waist circumference
Time frame: 24 weeks
Changes in waist circumference
Body fat percentage
Time frame: 24 weeks
Changes in body fat percentage
7 secondary outcomes
Dietary intake
Time frame: 24 weeks
Eating behavior
Time frame: 24 weeks
Physical activity level
Time frame: 24 weeks
Glycated haemoglobin (HbA1c)
Time frame: 24 weeks
Blood lipid profile (TC, LDL-C, HDL-C, Triglycerides)
Time frame: 24 weeks
Motivation for weight loss
Time frame: 24 weeks
Knowledge and perceptions
Time frame: 24 weeks
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 12 Mar 2025.
- Background: PubMed 37674889Nacis JS, Labrador JPH, Ronquillo DGD, Rodriguez MP, Dablo AMFD, Frane RD, Madrid ML, Santos NLC, Carrillo JJV, Fernandez MG, Gonzales GBL. A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet(R) study. Front Nutr. 2023 Aug 22;10:1238234. doi: 10.3389/fnut.2023.1238234. eCollection 2023.
- Derived from this study: PubMed 41654718Nacis J, Labrador JP, Ronquillo DG, Rementilla JC, Rodriguez M, Madrid M, Frane R, Santos NL, Dablo AMF, Carrillo JJ, Fernandez MG, Fanio DJ, Martirez DA, Paller M, Monje HS, Cabigan RM, Bausas AA, Agra GM, Bunhiyan R, van Duijnhoven FJB, Gonzales GB. Effect of gene-based vs. standard weight-loss recommendations on anthropometry, lipid and glucose markers, and dietary intake: a randomized controlled trial (the MyGeneMyDiet(R) Study). Genes Nutr. 2026 Feb 7;21(1):4. doi: 10.1186/s12263-026-00794-z.
- 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.
Jacus S Nacis, MBAH principal investigator
Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyGeneMyDiet® Recommendations for Weight Management in people with Overweight and Obesity, run by Food and Nutrition Research Institute, Philippines at 1 site in Philippines.
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 6 inclusion and 11 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 12 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 Philippines. 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?
5% weight loss (time frame: 24 weeks). 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 NCT05098899, which also lists 2 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 12 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.