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NCT Number: NCT07354438

Assessing the Effect of an Antioxidant-Rich Diet on Metabolic Syndrome Risk Using the Dietary Antioxidant Index

Metabolic syndrome (MetS) is a cluster of metabolic disorders characterized by elevated levels of blood glucose, hypertension, dyslipidemia, and abdominal obesity. Globally, it is a major public health concern. International studies have linked higher Dietary Antioxidant Index with reduced risk of MetS, as antioxidants play a role in lowering the risk of MetS by reducing oxidative stress, a key contributor to its pathophysiology. Exploring this link in Pakistan can provide valuable insights for dietary strategies to reduce the risk of MetS.

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Key information

Conditions

Metabolic Syndrome Risk Factors

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Veterinary & Animal Sciences, Lahore Pakistan

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Qaisar Raza, Ph.D

CONTACT

[email protected]

+92-3002479044

About this study

Background: Metabolic syndrome (MetS) is a cluster of metabolic disorders characterized by elevated levels of blood glucose, hypertension, dyslipidemia, and abdominal obesity. Globally, it is a major public health concern. International studies have linked higher Dietary Antioxidant Index (DAI) scores with reduced risk of MetS, as antioxidants play a role in lowering the risk of MetS by reducing oxidative stress, a key contributor to its pathophysiology. Exploring this link in Pakistan can provide valuable insights for dietary strategies to reduce the risk of MetS.

Hypothesis: A dietary intervention aimed at improving Dietary Antioxidant Index (DAI) scores beneficially affects Metabolic Syndrome risk factors among urban adults at risk of developing Metabolic Syndrome.

Material and Methods: A single-group pre-post human interventional study will be conducted among at-risk urban adults identified through the NCEP ATP III and WHO criteria. Dietary recalls will be analyzed in NutriSurvey using the Pakistan Food Composition Table, and any missing nutrient values will be supplemented from the Indian Food Composition Table. Nutrient data will be used to calculate the Dietary Antioxidant Index (DAI). Individuals with low DAI will receive dietary intervention.

Statistical Analysis: Pre-post changes in DAI and MetS markers will be assessed using paired t-tests, and Pearson's correlation will determine their associations using SPSS 25.

Expected Outcomes: The intervention is expected to reduce key Metabolic Syndrome risk factors while increasing individuals' awareness and motivation to adopt healthier behaviors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18-45 years
  • Metabolic syndrome risk (abdominal obesity & elevated BP as per NCEP ATP III criteria).
  • Low fruit & veg intake (<5 serv./day) as per WHO.
  • Willing to follow an intervention
  • Non-pregnant or lactating
  • Not diagnosed with malabsorption syndrome or chronic illness

Exclusion criteria

  • Individuals < 18 years or > 45 years
  • Not at risk of metabolic syndrome.
  • Adequate intake of fruits & veg (≥ 5 serv./day) as per WHO
  • Not willing
  • Pregnant or lactating
  • Diagnosed with malabsorption syndrome or chronic illness

Treatment and study plan

Antioxidant-Focused Diet Intervention

Other

This intervention specifically targets the Dietary Antioxidant Index (DAI) by increasing consumption of antioxidant-rich foods such as fruits, vegetables, whole grains, and legumes, while limiting pro-oxidant and ultra-processed foods. Unlike general healthy diet interventions, this study focuses on quantifiable antioxidant intake and its direct association with metabolic syndrome risk in urban adults.

Primary outcomes

  1. Change in Dietary Antioxidant Index (DAI)

    Time frame: Baseline and after 12 weeks of intervention

    DAI will be calculated from 24-hour dietary recalls to quantify total antioxidant intake. The primary objective is to assess whether the antioxidant-rich diet increases DAI in participants.

  2. Change in Metabolic Syndrome Risk Score

    Time frame: Baseline and after 12 weeks of intervention

    A composite metabolic syndrome risk score will be calculated by summing standardized z-scores of waist circumference (cm), fasting blood glucose (mg/dL), systolic blood pressure (mmHg), triglycerides (mg/dL), and inversely weighted HDL-cholesterol (mg/dL) to generate a single continuous measure of overall metabolic syndrome risk.

Secondary outcomes

  1. Change in Body Composition

    Time frame: Baseline and after 12 weeks of intervention

    Body composition, including body fat percentage and skeletal muscle mass, will be assessed using InBody analyzer to evaluate changes in body composition.

Study contacts

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

Anaum Javed, PG

CONTACT

[email protected]

+92-3040370308

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

Acronym: AD-MetS-DAI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 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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