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Recruiting NCT07354438

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

No phase Interventional Metabolic Syndrome Risk Factors

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: Antioxidant-Focused Diet Intervention.
Who it may be relevant to
Registry conditions: Metabolic Syndrome Risk Factors. Basic parameters: 18 years — 45 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 →

Overview

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.

Detailed description

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.

Interventions

  • Other Antioxidant-Focused Diet Intervention
    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 outcome measures

  • Change in Dietary Antioxidant Index (DAI) [Time frame: Baseline and after 12 weeks of intervention]
  • Change in Metabolic Syndrome Risk Score [Time frame: Baseline and after 12 weeks of intervention]
Secondary outcome measures (1)
  • Change in Body Composition [Time frame: Baseline and after 12 weeks of intervention]

Eligibility criteria

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

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • University of Veterinary & Animal Sciences, Lahore Pakistan — Lahore

Identifiers

NCT: NCT07354438 · UniversityVAS3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗