NCT04658264

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

Status unknown Phase 1 Last updated 8 December 2020

What this trial tests

Phase 1 trial testing Wheat-Barley Composite flour in Barley/Wheat Composite Flour in Type-2 Diabetes in 70 participants. Status unknown.

Timeline

15 January 2021

Primary endpoint
15 July 2021

15 July 2021

Quick facts

Lead sponsor	University of Veterinary and Animal Sciences, Lahore - Pakistan
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	15 January 2021
Primary completion	15 July 2021
Estimated completion	15 July 2021
Sites	1 location across Pakistan

Drugs / interventions tested

• Wheat-Barley Composite flour

Conditions studied

• Barley/Wheat Composite Flour in Type-2 Diabetes — all drugs for Barley/Wheat Composite Flour in Type-2 Diabetes →

Sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan

Who can join

25 and older, any sex, with Barley/Wheat Composite Flour in Type-2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.