Gluten Free Diet on Metabolic Syndrome

NCT07127055 | Completed DMC

• 1 other identifier: UOL/IREB/25/09/0008
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This study benefits the community by highlighting the potential of a gluten-free diet as a non-pharmacological, effective approach to managing obesity and type 2 diabetes. By demonstrating significant improvements in weight, blood sugar, lipid levels, and liver function, it supports dietary modification as a practical approach to enhancing metabolic health. The findings can inform public health initiatives, raise community awareness about the role of nutrition in disease management, and promote personalized dietary interventions, ultimately contributing to better prevention and control of chronic metabolic conditions.

Conditions

Metabolic Syndrome; Lipid Profile; HOMA-IR; Weight Change, Body

Outcome Measures

Primary Outcomes (3)

• Anthropometric measurement

  Baseline anthropometric measurements, including weight, height, BMI, and waist circumference, were recorded following standard clinical procedures. Weight was measured with a calibrated electronic scale while subjects wore light clothing and were barefoot. Height was measured using a calibrated stadiometer with subjects standing erect and barefoot. BMI was calculated as weight (kg) divided by height squared (m²). Waist circumference was measured with a non-elastic tape placed midway between the lowest rib and iliac crest, ensuring the tape touched the skin without compressing it.

  12 weeks

• 24-hour dietary recall method

  The 24-hour dietary recall method was used to assess participants' intake through structured interviews. A multi-pass approach ensured detailed and accurate reporting of food, portion sizes, and preparation methods. Recalls on non-consecutive days captured dietary variation, and data were analyzed using validated tools to estimate nutrient intake.

  12 WEEKS

• Assessment of Lipid Profile (mg/dL)

  Blood samples for baseline and follow-up tests were collected in EDTA-treated tubes to assess hematological parameters. Total cholesterol (TC), triglycerides (TG), and HDL levels were measured using an enzymatic colorimetric method, whereas LDL-C concentration was checked with the help of a formula. The following equation was used to calculate very low-density lipoprotein cholesterol (VLDL). VLDL - c (mg∕dL) = TG∕5 LDL = Total cholesterol - (HDL + VLDL)

  12 Weeks

Secondary Outcomes (2)

• Assessment of liver function (U/L)

  12 Weeks

• HOMA-IR

  12 Weeks

Study Arms (2)

Control group (T1): Conventional treatment + Standard Diet

PLACEBO COMPARATOR

Group T1 received a standard diet, 1800 kcal/day for 12 weeks

Other: No intervention

Treatment Group T2: Conventional treatment + Gluten-free diet 1800 Kcal/day

EXPERIMENTAL

Group T2 received a gluten-free diet for 12 weeks

Other: gluten free diet

Interventions

No intervention OTHER

Control group will take standard diet

Control group (T1): Conventional treatment + Standard Diet

gluten free diet OTHER

This group received gluten free diet

Treatment Group T2: Conventional treatment + Gluten-free diet 1800 Kcal/day

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who were obese diabetic adults of both genders, aged 30 to 55 years,
• body mass index (BMI) \> 25 kg/m²,
• fasting glucose level \> 135 mg/dL,
• elevated parameters of lipid profile,
• blood pressure \> 135/85 mmHg,
• Insulin Resistance (HOMA-IR) \> 2.57

You may not qualify if:

• Patients with a diagnosis of celiac disease,
• irritable bowel syndrome,
• some cancers,
• genetic illnesses,
• respiratory illnesses, and psychiatric illnesses

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Sana Noreen

Lahore, 54000, Pakistan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Metabolic Syndrome; Body Weight Changes

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 17, 2025
• Study Start: January 10, 2025
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

PA (1)