NCT07354438

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

January 21, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 17, 2025

Last Update Submit

January 14, 2026

Conditions

Keywords

AntioxidantsDietary antioxidant indexMetabolic Syndrome risk

Outcome Measures

Primary Outcomes (2)

  • Change in Dietary Antioxidant Index (DAI)

    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

  • Change in Metabolic Syndrome Risk Score

    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.

    Baseline and after 12 weeks of intervention

Secondary Outcomes (1)

  • Change in Body Composition

    Baseline and after 12 weeks of intervention

Study Arms (1)

Dietary Antioxidant Index-Based Dietary Intervention Arm

EXPERIMENTAL

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.

Other: Antioxidant-Focused Diet Intervention

Interventions

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.

Dietary Antioxidant Index-Based Dietary Intervention Arm

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Veterinary & Animal Sciences, Lahore Pakistan

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Study Officials

  • Qaisar Raza, Ph.D

    UNIVERSITY OF VETERINARY & ANIMAL SCIENCES, LAHORE PAKISTAN.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study uses a single-group interventional pre-post design to assess the effect of an antioxidant-rich diet on Dietary Antioxidant Index (DAI) and metabolic syndrome risk. Participants will receive an antioxidant rich dietary intervention, and changes in DAI and metabolic syndrome parameters will be measured before and after the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 21, 2026

Study Start

January 1, 2026

Primary Completion

April 1, 2026

Study Completion

April 15, 2026

Last Updated

January 21, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations