Composite Flour and Its Antdiabetic Potential

NCT05163587 | Completed DMC

• 1 other identifier: Composite flour
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Glucose, High; Body Weight Changes; Hyperlipidemias; Body Composition

Keywords

hyperglycemia; hyperlipidemia; weight control; diabetes type 2

Outcome Measures

Primary Outcomes (3)

• hbA1c

  by using low GI composite flour, the blood glucose levels of patients with type 2 diabetes should be controlled in a better way that can be determined by their hbA1c test value in 90 days

  90 days

• blood glucose levels

  by incorporating low GI food in daily meals will help lower the readings of daily blood glucose levels in patients with type 2 diabetes

  weekly

• lipid profile

  lipid profile of patients with type 2 diabetes will be improved

  90 days

Secondary Outcomes (2)

• body weight

  90 days

• body composition

  90days

Study Arms (2)

Control

PLACEBO COMPARATOR

control group will be provided with the commercially available whole-wheat flour for their consumption during the study period.

Combination Product: low GI composite flour

Intervention

EXPERIMENTAL

intervention group will be provided with low GI composite flour for their chapatis during study period and they will be instructed to consume at least 4 chapatis each day.

Combination Product: low GI composite flour

Interventions

low GI composite flour COMBINATION_PRODUCT

low GI composite flour orally in chapati form (3times/day)

Control; Intervention

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• type 2 diabetic patients of either sex that are non insulin dependent between age 30-60 years that are on oral medication only

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Veterinary and Animal Sciences, Lahore - Pakistan: lead

Study Sites (1)

University of Veterinary and Animal Sciences, Paksitan

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Body Weight Changes; Hyperlipidemias; Hyperglycemia; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Azka Adeeb Alvi, Mphil

  University of Veterinary and Animal Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Food Science and Human Nutrition

Model Details: two arm parallel assignment

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: December 20, 2021
• Study Start: March 26, 2021
• Primary Completion: December 5, 2021
• Study Completion: December 30, 2021
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

PA (1)