Clinical trial

Development of Low GI Composite Flour and Its Efficacy in Improving the Glycemic Profile in Type 2 Diabetes Patients _ A Randomized Clinical Trial.

Name
Composite flour
Description
A low glycemic multigrain flour for chapattis will be made from grains and cereals that are easily available in Pakistan. The nutritional profile and composition of test flour will be checked through proximate analysis method determined by AOAC. GI of test flour will be determined by comparing it with a reference food. The participants will be fed reference food i.e., 50gm glucose dissolved in 250ml water and test food serving having 50gm of available carbohydrates separately after an overnight fast. Finger prick method will be used to determine blood glucose levels at 0,15, 30, 45, 90 minutes. Trapezoidal rule will be used to determine iAUC and GI and GL will be determined by using standard formulas. Efficacy of test flour will be checked by human clinical trial. Control group will be fed chapatis made from test flour for 90 days. Anthropometry, body composition and biochemical measures including HbA1c, blood glucose (fasting and random) and lipid profile will be analyzed pre- and post-intervention and differences in their readings will be compared.
Trial arms
Trial start
2021-03-26
Estimated PCD
2021-12-05
Trial end
2021-12-30
Status
Completed
Treatment
low GI composite flour
low GI composite flour orally in chapati form (3times/day)
Arms:
Control, Intervention
Size
46
Primary endpoint
hbA1c
90 days
blood glucose levels
weekly
lipid profile
90 days
Eligibility criteria
Inclusion Criteria: * type 2 diabetic patients of either sex that are non insulin dependent between age 30-60 years that are on oral medication only Exclusion Criteria: * patients with biochemical evidence of other diseases, thyroid patients, pregnant and lactating mothers and those above the age of 60 years or those who use insulin to control their blood glucose levels
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two arm parallel assignment', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}
Updated at
2024-01-23

1 organization

1 product

5 indications

Indication
Blood Glucose
Indication
Hypertension
Indication
Hyperlipidemia