Metabolic SyndromeNCT07127055
Gluten Free Diet on Metabolic Syndrome
A study testing gluten free diet in people with Metabolic Syndrome and Lipid Profile, run by University of Lahore at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Metabolic Syndrome, Lipid Profile, HOMA-IR
- What is being tested?
- gluten free diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2025to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patients with a diagnosis of celiac disease,
- irritable bowel syndrome,
- some cancers,
- genetic illnesses,
- respiratory illnesses, and psychiatric illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Metabolic Parameters Among Obese Diabetic Individuals Through a Gluten-Free Diet
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.
Read the 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
- Being tested
- No intervention, gluten free diet
- Medical subject headings
- Metabolic Syndrome, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Control group will take standard diet
gluten free dietOther
This group received gluten free diet
| Study group | Role | What they receive |
|---|---|---|
| Control group (T1): Conventional treatment + Standard Diet | Placebo comparator | Group T1 received a standard diet, 1800 kcal/day for 12 weeks Receives: 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 Receives: Other: gluten free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 12 Weeks
Secondary outcomes (2)
Assessment of liver function (U/L)
Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and alanine aminotransferase (ALT) were estimated.
Measured: 12 Weeks
HOMA-IR
HOMA-IR was calculated to estimate insulin resistance from fasting blood glucose and fasting insulin. Blood was obtained from the subjects after an overnight fast of 8-12 hours. Serum insulin was measured by a validated enzyme-linked immunosorbent assay (ELISA), and fasting blood glucose was measured by a glucose oxidase assay. HOMA-IR value was subsequently calculated by the following formula:
HOMA-IR = Fasting Insulin (µU/mL)×Fasting Glucose (mg/dL)/405 This method provides an approximation of insulin resistance, with higher values being related to higher resistance. A HOMA-IR above 2.57 was used to denote insulin resistance in the present study
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start10 Jan 2025
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Noreen, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127055
- Sponsor's protocol ID
- UOL/IREB/25/09/0008
- Status last verified
- Jan 2025
- First submitted
- 8 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be accessible upon submission. Access will be provided through a secure data-sharing platform. Supporting documents, including the study protocol and statistical analysis plan, will also be available.
Publications
Naeem F, Noreen S, Sultan H, Aja PM. Modulation of metabolic parameters among obese diabetic individuals through a gluten-free diet. BMC Nutr. 2026 Apr 20;12(1):102. doi: 10.1186/s40795-026-01316-1.
PubMed 42010674
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Metabolic Parameters Among Obese Diabetic Individuals Through a Gluten-Free Diet
- ClinicalTrials.gov ID
- NCT07127055
- Acronym / sponsor ID
- UOL/IREB/25/09/0008
- Conditions
- Metabolic Syndrome, Lipid Profile, HOMA-IR, Weight Change, Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (T1): Conventional treatment + Standard Diet | Placebo comparator | Other: No interventionGroup T1 received a standard diet, 1800 kcal/day for 12 weeks |
| Treatment Group T2: Conventional treatment + Gluten-free diet 1800 Kcal/day | Experimental | Other: gluten free dietGroup T2 received a gluten-free diet for 12 weeks |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- Patients with a diagnosis of celiac disease,
- irritable bowel syndrome,
- some cancers,
- genetic illnesses,
- respiratory illnesses, and psychiatric illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionControl group will take standard diet | Other | Control group (T1): Conventional treatment + Standard Diet |
| gluten free dietThis group received gluten free diet | Other | Treatment Group T2: Conventional treatment + Gluten-free diet 1800 Kcal/day |
Primary outcome
Anthropometric measurement
Time frame: 12 weeks
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.
24-hour dietary recall method
Time frame: 12 WEEKS
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.
Assessment of Lipid Profile (mg/dL)
Time frame: 12 Weeks
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)
2 secondary outcomes
Assessment of liver function (U/L)
Time frame: 12 Weeks
HOMA-IR
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Derived from this study: PubMed 42010674Naeem F, Noreen S, Sultan H, Aja PM. Modulation of metabolic parameters among obese diabetic individuals through a gluten-free diet. BMC Nutr. 2026 Apr 20;12(1):102. doi: 10.1186/s40795-026-01316-1.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be accessible upon submission. Access will be provided through a secure data-sharing platform. Supporting documents, including the study protocol and statistical analysis plan, will also be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gluten free diet in people with Metabolic Syndrome and Lipid Profile, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurement (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07127055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.