- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07362550
Effects of 12-Week Balanced Diet on Body Composition & Metabolic Parameters in Twins (TWIN-BD12)
A Comparative Study of Monozygotic and Dizygotic Twins: Evaluating the Effects of a 12-Week Balanced Diet Intervention on Body Composition and Metabolic Parameters.
Study Overview
Detailed Description
Background: Twin studies help separate genetic and environmental influences on diet and metabolic health. With rising obesity and metabolic disorders in Pakistan, there is no twin-based dietary intervention data. Filling this gap is essential for developing effective, evidence-based personalized nutrition strategies.
Hypothesis: The null hypothesis states that there will be no difference in dietary response or within-pair similarity between monozygotic and dizygotic twins. The alternative hypothesis suggests that monozygotic twins will show greater similarity in diet response and that the balanced diet will significantly improve metabolic outcomes.
Methodology: A 12-week randomized controlled trial will recruit Monozygotic and Dizygotic twins aged 18-60 years in Lahore, Pakistan. Participants of interventional group will follow a WHO-aligned balanced diet. Body composition, metabolic markers, and dietary adherence will be assessed at baseline and week 12.
Statistical Design: Analyses will be conducted in SPSS using paired t-tests for within-pair comparisons and independent t-tests for Monozygotic vs. Dizygotic differences. Effect sizes will be calculated, with significance set at p < 0.05.
Expected Outcomes: The study is expected to show that the balanced diet improves metabolic and body composition outcomes, with monozygotic twins displaying more similar responses than dizygotic twins. These findings will clarify genetic vs. environmental effects and support more targeted nutrition recommendations in Pakistan.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Qaisar Raza, Ph.D
- Phone Number: +92-3002479044
- Email: qaisar.raza@uvas.edu.pk
Study Contact Backup
- Name: Momina Azhar Mehmood, Postgraduate
- Phone Number: +92-3227642452
- Email: mominaazhar1612@gmail.com
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- University of Veterinary and Animal Sciences, Lhr.
-
Contact:
- Qaisar Raza, Ph.D
- Phone Number: +92-3002479044
- Email: qaisar.raza@uvas.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female twins aged 18-60 years.
- Confirmed zygosity (MZ or DZ) based on a validated twin zygosity questionnaire.
- Both twins willing to participate for the entire intervention period.
- Free from chronic diseases requiring specialized diets (e.g., type 1 diabetes, celiac disease).
- Not currently enrolled in another dietary or lifestyle intervention study.
Exclusion Criteria:
- Pregnant or lactating women.
- Use of lipid-lowering, glucose-lowering, or weight-loss medications in the past 3 months.
- Major gastrointestinal disorders or conditions affecting nutrient absorption.
- Unwillingness to follow individualized dietary counseling or complete study assessments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Habitual Diet
Control group will remain on habitual Diet.
|
|
|
Experimental: Balanced Diet
12-week culturally adapted WHO-aligned balanced diet emphasizing whole grains, lean proteins, healthy fats, fruits, and vegetables, individualized based on basal metabolic rate (BMR) and physical activity levels will be provided to interventional arm.
|
12-week culturally adapted WHO-aligned balanced diet emphasizing whole grains, lean proteins, healthy fats, fruits, and vegetables. Macronutrient composition: 45-65% carbohydrates, 20-35% fats, 10-20% protein. Individualized based on basal metabolic rate (BMR) and physical activity. Weekly counseling and monitoring through dietary recalls and photographic diaries. This intervention aims to assess the effects of a balanced diet on body composition and metabolic parameters in monozygotic and dizygotic twins. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Fat Percentage (%)
Time Frame: Baseline and after 12-Week of Intervention.
|
Change in total body fat percentage measured using the InBody analyzer to assess the effect of a 12-week balanced diet intervention.
|
Baseline and after 12-Week of Intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fasting Plasma Glucose (mg/dL)
Time Frame: Baseline and after 12 weeks
|
Change in fasting plasma glucose concentration measured to assess the metabolic effect of the 12-week balanced diet intervention. Unit: mg/dL Tool: Venous blood sample, enzymatic laboratory method |
Baseline and after 12 weeks
|
|
Change in Lipid Profile (mg/dL)
Time Frame: Baseline and after 12 weeks
|
Change in fasting serum lipid concentrations measured to assess metabolic response to the 12-week balanced diet intervention. Includes: Total Cholesterol (mg/dL) Low-Density Lipoprotein (LDL-C, mg/dL) High-Density Lipoprotein (HDL-C, mg/dL) Triglycerides (mg/dL) Unit: mg/dL Tool: Venous blood sample, standard enzymatic laboratory methods |
Baseline and after 12 weeks
|
|
To compare within-pair similarity of Dietary Response
Time Frame: Baseline and after 12-Weeks of intervention
|
To compare the within-pair similarity of diet response between Monozygotic (MZ) and Dizygotic (DZ) twins, allowing estimation of genetic versus environmental contributions to dietary effects.
|
Baseline and after 12-Weeks of intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Qaisar Raza, Ph.D, University of Veterinary and Animal Sciences, Lhr.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UniversityUVAS1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Adults
-
Aix Marseille UniversitéNot yet recruitingHealthy Young Adults | Healthy Older AdultsFrance
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
Fundacion Clinic per a la Recerca BiomédicaNot yet recruitingHealthy Adult Participants | Non-smoking, Healthy Adults | Normal Weight AdultsSpain
-
KU LeuvenCompletedHealthy Older Adults | Ill Older AdultsBelgium
-
Samsung Medical CenterTerminatedHealthy Aging | Healthy AdultsKorea, Republic of
-
King Abdulaziz UniversityUniversity College Dublin; Royal College of Surgeons, IrelandRecruitingHealthy Adults | Healthy NutritionSaudi Arabia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Balgrist University HospitalNot yet recruiting
-
Essilor InternationalRecruiting
-
University of PennsylvaniaNational Institute on Aging (NIA)Not yet recruiting
Clinical Trials on Balanced Diet
-
Chang Gung Memorial HospitalRecruitingSystemic Lupus Erythematosus | Ketogenic DietingTaiwan
-
University of Roma La SapienzaCompleted
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...UnknownCeliac DiseaseItaly
-
University College, LondonUniversity College London HospitalsCompletedObesity | Overweight | Cardiometabolic SyndromeUnited Kingdom
-
National Heart, Lung, and Blood Institute (NHLBI)Completed
-
roberta cazzolaIstituti Clinici di Perfezionamento di Milano; Luigi Sacco University HospitalCompletedMetabolic Syndrome | Obesity, Metabolically BenignItaly
-
Mondelēz International, Inc.Centre de Recherche en Nutrition Humaine Rhone-Alpe; Biofortis Mérieux NutriSciencesCompleted
-
Aga Khan UniversityBill and Melinda Gates FoundationNot yet recruitingPregnancy | Heat Stress | Nutrition Status | Women of Reproductive AgePakistan
-
University Hospital of CreteRecruitingDietary Habits | Cholelithiases | Postcholecystectomy Syndrome | Gallstone Disease | Gallstone; Colic | Gallstone; Cholecystitis, AcuteGreece
-
Mondelēz International, Inc.Centre de Recherche en Nutrition Humaine Rhone-Alpe; Biofortis Mérieux NutriSciencesCompleted