- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07015814
- Original Trial
Comparative Evaluation of Glycemic Index of Different Types of Jaggery Produced Locally in Pakistan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Naseer Ahmed
- Phone Number: 03305485960
- Email: dr.naseer99@mail.com
Study Locations
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KP
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Peshawar, KP, Pakistan, 092
- Rehman Medical Institue
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:Participants should be clinically healthy, as determined by their medical records and verbal history. Only individuals with normal fasting blood glucose levels (70-99 mg/dL) during screening will be eligible -
Exclusion Criteria:1) Participants must not have any chronic disease, not be taking any medications that influence carbohydrate metabolism (such as corticosteroids or metformin), and should be non-smokers and non-alcoholics.
2) Pregnant or lactating female participants, as well as any person with gastrointestinal, metabolic, or endocrine disease (e.g., thyroid disease, PCOS, IBD), will be excluded.
3) Also, subjects with a history of recent acute illness (within the last 2 weeks) will be deferred.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Single group (cross over)
Participants will receive all test interventions (2 different varieties of jaggery and a glucose reference) in a randomized sequence with appropriate washout periods between each session.
Blood glucose levels will be measured after each test food to determine and compare glycemic index values.
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Participants will consume a standardized portion of jaggery Type A providing 50 grams of available carbohydrates.
Capillary blood glucose will be measured over a 2-hour postprandial period.
Participants will consume a standardized portion of jaggery Type B providing 50 grams of available carbohydrates.
Capillary blood glucose will be measured over a 2-hour postprandial period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic Index (GI) of Different Types of Jaggery
Time Frame: Measured at multiple time points post-consumption (e.g., 0, 15, 30, 45, 60, 90, and 120 minutes) during each test session.
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The incremental area under the blood glucose response curve (iAUC) over 2 hours after consumption of each type of jaggery, expressed as a percentage of the glucose reference.
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Measured at multiple time points post-consumption (e.g., 0, 15, 30, 45, 60, 90, and 120 minutes) during each test session.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postprandial Blood Glucose Response Curve
Time Frame: Same as primary outcome (0-120 minutes).
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Blood glucose levels at each time point following consumption of jaggery types and glucose, to assess the shape and peak of glycemic response.
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Same as primary outcome (0-120 minutes).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Jenkins DJ, Wolever TM, Taylor RH, Barker H, Fielden H, Baldwin JM, Bowling AC, Newman HC, Jenkins AL, Goff DV. Glycemic index of foods: a physiological basis for carbohydrate exchange. Am J Clin Nutr. 1981 Mar;34(3):362-6. doi: 10.1093/ajcn/34.3.362.
- Fats and oils in human nutrition. Report of a joint expert consultation. Food and Agriculture Organization of the United Nations and the World Health Organization. FAO Food Nutr Pap. 1994;57:i-xix, 1-147. No abstract available.
- International Diabetes Federation. (2021). *IDF Diabetes Atlas* (10th ed.). Brussels, Belgium: IDF.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GL/GI-NA_1V2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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