Composite Flour and Its Antdiabetic Potential
Condition: Blood Glucose, High; Body Weight Changes; Hyperlipidemias; Body Composition
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias; Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      The study comprises of four different phases.

        -  Phase 1: To develop a low GI composite flour.

        -  Phase 2: To assess nutritional profile and composition of the composite flour.

        -  Phase 3: To determine GI of chapatis made from test flour.

        -  Phase 4: Test the efficacy of test flour in improving glycemic profile through clinical
           trial.

      Subjects: A total of 30 Type 2 diabetic patients aged between 30-60 years that are on oral
      medication will be selected for participation. They can be of either sex with no other
      complications of the disease. A written consent from the participants will be taken prior to
      study. Those participants who have insulin dependency, thyroid issues, are smokers and
      pregnant and lactating mothers will be excluded from the study. Prior to study,
      anthropometric measurements that will include height, weight, BMI, hip to waist ratio of each
      participant will be done. All the participants will complete testing for their HbA1c, lipid
      profile, fasting and random blood glucose measurements prior to study. For this, they will be
      called to University of Veterinary and Animal Sciences, Lahore for their blood sample
      collection. All the participants will be divided into two groups: control and intervention
      group with 15 participants in each group. The study will be conducted for 90 days and only
      those participants will be recruited that will be willing to complete the study duration with
      all the protocols for it. These include no major change in dietary pattern during the study.
      No change in physical activity i.e. doing any intense exercise or following any new workout
      routines. No change in medications or supplements during the study period is recommended.

      Experimental design: The participants in the intervention group will be provided test flour
      for their chapattis (2kg for 10 days). The flour will be provided after each 10 days and they
      will be asked to use this flour for their chapattis. They will be guided to consume at least
      3-4 chapattis each day while the participants in the control group will be asked to continue
      the flour, they are already using for their chapatti making. However during the study period
      all the participants will continue to follow their regular dietary habits, physical activity
      patterns and will continue taking their diabetes medication as per their schedule.

      Biochemical testing: Along with the anthropometry, the participants will be tested
      biochemically by taking their blood samples at the start and at the end of the study. Before
      starting the trial, each participant will be tested for HbA1c and lipid profile. HbA1c tests
      will be done by Ion Exchange Resin method by using Glycohemoglobin HbA1 kit of brand Human
      Diagnostics. Lipid profile will also be checked at the baseline and after 3 months. For this
      purpose, Human diagnostic Kit will be used i.e. cholesterol liquicolor kit for cholesterol
      assessment, HDL cholesterol kit by Human diagnostics for HDL measurement, LDL liquicolor kit
      and TG Liquicolor mono kit by Human Diagnostics for LDL and triglycerides assessment. Random
      and Fasting blood glucose levels will be checked after every 10 days by using finger prick
      method through Glucometer (ACCU-CHECK® Performa Nano, Mannhim, Germany). For their
      interpretation, Guidelines of National Cholesterol Education Program (NCEP), (2004) will be
      used.

      Statistical analysis: Statistical Package for Social Science software ( version 22) will be
      used for data analysis. Independent t test will be applied to check the differences between
      control and intervention groups. Paired t test will be used to determine differences among
      groups at initial and final time points within a group and their association will be checked
      at significance level of <0.05. Repeated measure design will be used to compare the blood
      glucose levels after every 10 days.
    

Intervention name(s): low GI composite flour
Intervention type(s): Combination Product
Intervention description(s): low GI composite flour orally in chapati form (3times/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two arm parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: hyperglycemia; hyperlipidemia; weight control; diabetes type 2