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Идёт набор NCT07362550

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

Без фазы С лечением Healthy Adults

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Balanced Diet.
Кому может быть актуально
Состояния в реестре: Healthy Adults. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • University of Veterinary and Animal Sciences, Lhr. — Lahore

Идентификаторы

NCT: NCT07362550 · UniversityUVAS1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗