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Recruiting NCT07362550

Effects of 12-Week Balanced Diet on Body Composition & Metabolic Parameters in Twins

No phase Interventional Healthy Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Balanced Diet.
Who it may be relevant to
Registry conditions: Healthy Adults. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Comparative Study of Monozygotic and Dizygotic Twins: Evaluating the Effects of a 12-Week Balanced Diet Intervention on Body Composition and Metabolic Parameters.

Overview

Twin study in Lahore will assess genetic vs. environmental effects on diet and metabolism. Over 12 weeks, monozygotic and dizygotic twins will follow a WHO-aligned balanced diet. Body composition, metabolic markers, and adherence will be measured. Monozygotic twins are expected to show greater similarity in response, clarifying personalized nutrition strategies in Pakistan.

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.

Interventions

  • Other Balanced Diet
    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 diz

Primary outcome measures

  • Change in Body Fat Percentage (%) [Time frame: Baseline and after 12-Week of Intervention.]
Secondary outcome measures (3)
  • Change in Fasting Plasma Glucose (mg/dL) [Time frame: Baseline and after 12 weeks]
  • Change in Lipid Profile (mg/dL) [Time frame: Baseline and after 12 weeks]
  • To compare within-pair similarity of Dietary Response [Time frame: Baseline and after 12-Weeks of intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • University of Veterinary and Animal Sciences, Lhr. — Lahore

Identifiers

NCT: NCT07362550 · UniversityUVAS1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗