Gluten Free Diet on Metabolic Syndrome

NCT ID: NCT07127055

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2025-04-10

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.

Detailed Description

2.1. The study received ethical approval from the Institute Research Ethics Board (IREB), University of Lahore (UOL/IREB/25/09/0008). Informed consent was obtained from all participants, who were fully briefed on the study's purpose, procedures, risks, and benefits, with the option to ask questions and withdraw at any time.

2.2. Study design The research trial, a randomized controlled trial (RCT), was carried out at the Dilawar Hussain Foundation, Diabetes Management Center, Lahore, Pakistan.

An intervention with a tailored gluten-free diet of 1800 kcal/day was planned. 2.3. Methods of data collection A total of 115 volunteers who met the inclusion criteria were recruited into the study. Seven participants left the study due to personal issues; a total of 108 patients left, which were divided into two equal groups (n=54 in each group).

Participants were randomly allocated to two study groups. Group T1 received a standard diet, whereas Group T2 received a gluten-free diet for 12 weeks. An 1800 kcal/day diet was nutritionally comparable, 50-55% of calories were from carbohydrates, 15-20% protein, and 25-30% fat. Fiber in the form of fruits, vegetables, legumes, and the right grains. The gluten-free variant omitted all sources of wheat, rye, and barley and thus was the ideal option for those needing a gluten-free diet. Follow-up sessions on alternate days were used to guarantee compliance throughout the intervention period, where dietary adherence was checked and reinforced. At the end of week 12th, biochemical tests were performed for all the subjects. The post-interventional measurements between the two groups were then compared to assess the metabolic effects of the gluten-free diet. This comparison was used to test the main hypothesis of the study.

2.4. Parameters for assessment The final dataset comprised anthropometric data: weight, height, body mass index (BMI), and waist circumference, 24-hour dietary recall, as outlined. In addition, fasting glucose level, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), systolic and diastolic blood pressure, and lipid profiles in serum (LDL, HDL, and total cholesterol) were measured using the same procedure.

2.5 Statistical analysis Data analysis was performed using SPSS version 25. Continuous variables were summarized as mean ± standard deviation, while categorical variables were presented as frequencies and percentages. Baseline and post-study comparisons were made using paired sample t-tests, with significance set at p ≤ 0.05 .

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group (T1): Conventional treatment + Standard Diet

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

Group Type: PLACEBO_COMPARATOR

No intervention

Intervention Type: OTHER

Control group will take standard diet

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

Group T2 received a gluten-free diet for 12 weeks

Group Type: EXPERIMENTAL

gluten free diet

Intervention Type: OTHER

This group received gluten free diet

Interventions

No intervention

Control group will take standard diet

Intervention Type: OTHER

gluten free diet

This group received gluten free diet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Sana Noreen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sana Noreen

Lahore, , Pakistan

Countries

Pakistan

Related Links

https://pubmed.ncbi.nlm.nih.gov/30362336/

Related Info

Other Identifiers

UOL/IREB/25/09/0008

Identifier Type: -

Identifier Source: org_study_id