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NCT Number: NCT07362550

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

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Veterinary and Animal Sciences, Lhr.

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Qaisar Raza, Ph.D

CONTACT

[email protected]

+92-3002479044

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Balanced Diet

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Momina Azhar Mehmood, Postgraduate

CONTACT

[email protected]

+92-3227642452

Qaisar Raza, Ph.D

CONTACT

[email protected]

+92-3002479044

Sponsors and collaborators

Lead sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan

Other

Registry information

Official study 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.

Acronym: TWIN-BD12

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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