- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07354438
Assessing the Effect of an Antioxidant-Rich Diet on Metabolic Syndrome Risk Using the Dietary Antioxidant Index (AD-MetS-DAI)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anaum Javed, PG
- Phone Number: +92-3040370308
- Email: anaumjaved768@gmail.com
Study Contact Backup
- Name: Qaisar Raza, Ph.D
- Phone Number: +92-3002479044
- Email: qaiasr.raza@uvas.edu.pk
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- University of Veterinary & Animal Sciences, Lahore Pakistan
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Contact:
- Qaisar Raza, Ph.D
- Phone Number: +92-3002479044
- Email: qaisar.raza@uvas.edu.pk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Dietary Antioxidant Index-Based Dietary Intervention Arm
Participants in this arm will receive an antioxidant-rich dietary intervention designed to improve the Dietary Antioxidant Index (DAI).
The intervention includes guidance to increase intake of fruits, vegetables, whole grains, legumes, and antioxidant-rich foods while limiting pro-oxidant and ultra-processed foods.
Changes in DAI and metabolic syndrome components will be assessed before and after the intervention.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Dietary Antioxidant Index (DAI)
Time Frame: Baseline and after 12 weeks of intervention
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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.
|
Baseline and after 12 weeks of intervention
|
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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.
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Baseline and after 12 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline and after 12 weeks of intervention
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Collaborators and Investigators
Investigators
- Principal Investigator: Qaisar Raza, Ph.D, UNIVERSITY OF VETERINARY & ANIMAL SCIENCES, LAHORE PAKISTAN.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UniversityVAS3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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