An interventional study of Antioxidant-Focused Diet Intervention in Metabolic Syndrome Risk Factors, sponsored by University of Veterinary and Animal Sciences, Lahore - Pakistan. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by University of Veterinary and Animal Sciences, Lahore - Pakistan · Not applicable, Interventional, and Treatment
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.
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.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 55 is close to the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Veterinary and Animal Sciences, Lahore - Pakistan is the lead sponsor of 27 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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
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.
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.
Time frame: 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.
Time frame: Baseline and after 12 weeks of intervention
Change in Body Composition
Body composition, including body fat percentage and skeletal muscle mass, will be assessed using InBody analyzer to evaluate changes in body composition.
Time frame: Baseline and after 12 weeks of intervention
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2026; primary completion for Apr 2026, 3 months later.
Of 625 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 3 months is below that.
Counting every sponsor, half of 675 studies reached it within 20 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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University of Veterinary and Animal Sciences, Lahore - Pakistan