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Nutrient Profiling and Bio-efficacy of Wheat-Barley Composite Flour in Type-2 Diabetes a in Randomized Control Clinical Trial

NCT04658264 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-12-08

No results posted yet for this study

Summary

Diabetes is a chronic disorder of metabolism characterized by hyperglycemia, defect in Insulin secretion, defection in Insulin action or both, which has a high potential for serious complications with high mortality and morbidity, if poorly treated. Outcome improves with better control.

It is a very common disorder with current global prevalence of 425 million and the latest diabetes survey of Pakistan in 2017-18 shows a prevalence of 26 % in adults.

Lifestyle intervention especially nutritional modification was the earliest intervention tried and still relevant. Strict Diet plans are difficult to follow; hence a functional Food based intervention is more likely to be acceptable. Various functional foods have been tried in diabetes but beta glucan , a soluble fiber found in barley has been widely tested and found to be effective not only in controlling glycemia, but also in improvement of dyslipidemia, blood pressure and weight.

This study has been planned with the objectives of formulating a composite flour based on wheat and barley, which is palatable, economical and can be used instead of wheat flour in the routine diet of people with diabetes.Xanthan Gum shall be added to compensate for the gluten loss. Various ratios of the flour shall be tested for sensory qualities, rheology, and glycemic index, and beta glucan content, and an acceptable flour with best attributes shall be further evaluated through proximate analysis and finally tested in a randomized in an open label randomized controlled clinical trial in real patients at Akhuwat Medical Center which is a charity facility.The sample size for a power of 90 has been calculated to be 31 and adding for dropouts , rounded up to 35 for each group. 70 Adult non pregnant Type 2 Diabetics above the age of 25, with no serious comorbidity shall be recruited and randomized through computer generated random number table. One group shall receive the 2 kg of composite flour every week for 3 months in addition to usual treatment while the con troll group shall receive only the usual treatment.

BMI, HbA1C, Creatinine, fasting lipid profile and ALT shall be measured at the start and end of the study, while ,Fasting and post meal sugars, BP, appetite, satiety, and compliance shall be measured every week. The data shall be processed in SPSS 23 This study is expected to show a significant improvement in glycemic control with a possible benefit in BP, weigh and lipid profile as well

Conditions

  • Barley/Wheat Composite Flour in Type-2 Diabetes

Interventions

DIETARY_SUPPLEMENT

Wheat-Barley Composite flour

A combination of wheat and barley flour with 0.5% food grade xanthan gum as replacement for lost gluten, tested for sensory properties, nutrient profile, and rheology

Sponsors & Collaborators

  • University of Veterinary and Animal Sciences, Lahore - Pakistan

    lead OTHER

Principal Investigators

  • Muhammad Asif Mahmood, MCPS · Student at University of Veterinary and Animal Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2021-07-15
Completion
2021-07-15

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04658264 on ClinicalTrials.gov