Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05098899
Other study ID # 19-003-00-00000-2-12-6-2021
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date August 31, 2024

Study information

Verified date December 2023
Source Food and Nutrition Research Institute, Philippines
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 62
Est. completion date August 31, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 59 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
MyGeneMyDiet® Recommendations for Weight Management
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
Other:
Usual Standard of Care for Weight Management
This group will receive the conventional and standard nutrition lifestyle recommendation for weight management

Locations

Country Name City State
Philippines Department of Science and Technology-Food and Nutrition Research Institute Taguig Metro Manila

Sponsors (1)

Lead Sponsor Collaborator
Food and Nutrition Research Institute, Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary 5% weight loss Attainment of 5% weight loss 24 weeks
Primary 10% weight loss Attainment of 10% weight loss 48 weeks
Primary Body mass index Changes in BMI 24 weeks
Primary Waist circumference Changes in waist circumference 24 weeks
Primary Body fat percentage Changes in body fat percentage 24 weeks
Secondary Dietary intake Improvements in dietary intake 24 weeks
Secondary Eating behavior Improvements in eating behavior 24 weeks
Secondary Physical activity level Improvements in physical activity level 24 weeks
Secondary Glycated haemoglobin (HbA1c) Changes in HbA1c 24 weeks
Secondary Blood lipid profile (TC, LDL-C, HDL-C, Triglycerides) Changes in TC, LDL-C, HDL-C, Triglycerides 24 weeks
Secondary Motivation for weight loss Stages and motivation for weight loss 24 weeks
Secondary Knowledge and perceptions Knowledge and perceptions in nutrigenomics and genetic testing 24 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Recruiting NCT05354245 - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL) N/A
Completed NCT03602001 - Attentive Eating for Weight Loss N/A
Recruiting NCT06269159 - The Power of 24-hour: Co-designing Intervention Components
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02996864 - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II N/A
Completed NCT04647149 - Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity N/A
Terminated NCT03914066 - A Group-based Treatment of Overweight and Obesity in Primary Care N/A
Completed NCT03685656 - Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers N/A
Completed NCT05051579 - A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities Phase 2
Completed NCT04611477 - Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals N/A
Active, not recruiting NCT05330247 - Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study N/A
Completed NCT03599115 - Effects of Inhibitory Control Training in Eating Behaviors N/A
Recruiting NCT05938894 - Train Your Brain - Executive Function N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Recruiting NCT05987306 - A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss N/A
Completed NCT03792685 - Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention N/A
Completed NCT05055362 - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study N/A
Completed NCT04520256 - Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy Phase 2/Phase 3
Completed NCT04979234 - A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome N/A