Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04658264 |
| Other study ID # |
039/IRC/BMR |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2021 |
| Est. completion date |
July 15, 2021 |
Study information
| Verified date |
December 2020 |
| Source |
University of Veterinary and Animal Sciences, Lahore - Pakistan |
| Contact |
Muhammad Asif Mahmood, MCPS |
| Phone |
+9242111770000 |
| Email |
asifmkadri[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
Description:
Background: Diabetes is a chronic disorder of metabolism characterized by hyperglycemia,
defect in Insulin secretion, defect 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.
Hypothesis: Wheat-barley composite flour replaced with wheat in the diet of diabetics will
improve their glycemic control.
Methodology: The study shall be conducted in two phases. In phase-1, a wheat barley composite
flour shall be developed. Four preparations of the flour shall be developed consisting of
pure full grain wheat flour, and three combinations of wheat and barley (W:B) in the ratio of
70:30, 65:35 and 60:40 shall be prepared. Food grade xanthan gum shall be added; 0.5 grams
each to all the three wheat barley composites in order to compensate for the gluten loss. All
the four flours shall be tested for sensory qualities, rheology, glycemic index, and beta
glucan content, and an acceptable composite flour with best attributes shall be further
evaluated through proximate analysis. This chosen composite shall be tested in phase-2, in a
randomized 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
control group shall receive only the usual treatment.
Data collection: 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, blood pressure,
appetite, satiety, and compliance shall be measured every week. Change in HbA1C from baseline
to end of study will be our primary outcome while changes all the other parameters will be
our secondary outcomes.
Statistical analysis: The data shall be processed in SPSS 23. HbA1C, BMI, Lipid profile,
creatinine and ALT shall be for analysis of Variance (ANOVA), and weakly changes in Fasting
and post meal sugars, blood pressure, appetite, satiety and compliance shall be evaluated
through factorial analysis to assess the effect of composite flour over time. Both analyses
shall be conducted with a Significance Level at P - value < 0.05 for all the parameters
Expected outcomes: This study is expected to show a significant improvement in glycemic
control with a possible benefit in BP, satiety, weight and lipid profile.
STATEMENT OF THE PROBLEM
Diabetes is a very common chronic disorder across the globe including Pakistan. Poor control
of this disease can lead to serious and fatal acute as well as chronic complications.
Management of diabetes is however difficult and cumbersome, especially in the sense that it
involves continued lifestyle modifications, including dietary constraints and restraints. It
would be ideal for people with diabetes to have one such food in their diet, which can manage
their diabetes and relieves them of all the bother to manage their every single meal for
maintaining a reasonable glycemic control.
This ideal though seems very far at this moment, functional foods and nutraceuticals are a
fair step in this direction. Barley due to its high content of the soluble fiber beta glucan
has been shown to help glycemic control, but barley does not make good dough, while isolated
beta glucan is very expensive to be used in every day diet of the common man.
The Present study is designed with the objective of formulating a nutritionally efficient
wheat barley composite flour, which is not only palatable and economical but can replace the
wheat flour chapattis in the diet of people with t ype-2 diabetes and will improve their
glycemic control simply by this substitution. This effect shall be substantiated through a
randomized controlled clinical trial
HYPOTHESIS
Wheat-barley composite flour replaced with wheat in the diet of diabetics will improve their
glycemic control
MATERIALS AND METHODS This Study will be conducted in two phases
1. Product development and Nutrient Profiling,
2. Open Label Randomized controlled Clinical Trial in Human Volunteers
PHASE-1 (PRODUCT DEVELOPMENT AND NUTRIENT PROFILING)
Procurement of raw Material
1. Whole grain wheat flour shall be procured from "Rehmat Flour Mills, Ravi Road Lahore
2. Barley Flour Shall be procured from the local grain market, Akbari Mandi Lahore.
3. Food Grade Xanthan Gum shall be Obtained from the local Chemical Market, Shah Aalam
Market Lahore.
Product Development Three formulations of the composite flour and one of the whole wheat
flour shall be prepared for comparative sensory testing as follows Name Wheat % Barley %
Xanthan Gum % A 100 0 0 B 69.5 30 0.05 C 64.5 35 0.05 D 59.5 40 0.05
Sensory Testing Chapattis (flat bread from unleavened flour) shall be made from all the four
types of flour, and shall be presented before an expert panel with five numbers, who shall
vote for the following characteristics on an interval scale of 1-5 (Basic Sensory Methods for
Food Evaluation)
1. Color
2. Odor
3. Texture
4. Taste
5. Overall acceptability
Rheology Studies Rheology studies shall be conducted for all the four formulations with
the help of Rheometer at Rehmat Flour Mills laboratory.
Glycemic Index Glycemic Index of all the four formulations shall be conducted according
to standard international method as described by the Glycemic index foundation (Brouns F
et al.,2005).
The formulation of the flour to be used for the clinical trial shall be selected on the
basis of the best match for sensory attributes, the Rheological properties and the
glycemic Index. This Chosen formulation shall hitherto be named as "Diaflour"
Proximate Analysis The Composite flour mixture will be analyzed for moisture, ash, crude
protein, crude fiber, crude fat and Nitrogen free extract (NFC) according to their
respective methods (AOAC, 2019) Mineral Contents Minerals Like Na, Ca, and K will be
estimated by flame photometer according to the procedures of AOAC (2006).
Beta-Glucan Content The Beta-glucan content of the selected Diaflour shall also be
determined through standard methods PHASE-2 (OPEN LABEL RANDOMIZED CONTROL CLINICAL
TRIAL)
An open label randomized controlled clinical trial shall be conducted on real patients
of type-2 Diabetes patients at the Diabetic Clinic of Akhuwat Medical Center Township
Lahore which is a charity Diabetes service Sample size calculation Sample size has been
calculated according to Chan's method (Chan, 2003). We used Table |II of Page 174 with
the parameter delta =0.9 with 90% power of the test for rejecting the false hypothesis,
which requires 27 participants in both groups. Adding up for drop-outs, we have rounded
up the figure 35+35 Participants Seventy consecutive consenting volunteers shall be
recruited over a period of 3 months according to the following criteria A. Inclusion
Criteria
1. People with Type-2 Diabetes of any duration
2. Age ≥ 25
3. Consenting to participate B. Exclusion Criteria
1. People with Type-1 Diabetes
2. All pregnant Ladies
3. Any serious comorbidity unrelated to diabetes on clinical evaluation
4. People with advanced kidney and liver disease Randomization The enrolled
participants shall be randomized according to computer generated random numbers
table and divided in to two groups A. Diaflour Group B. Usual Treatment Group
Treatment A. Composite Flour Group The composite flour (treatment) group shall
continue to receive the usual treatment suggested by their physician along with any
changes that the physician deems necessary during the 3 month period of this study.
They will additionally receive 2 Kg of the composite flour every week, sufficient
for 21 chapattis, and shall eat chapattis made from this flour instead of their
usual wheat flour chapattis.
B. Usual Treatment Group This group shall receive only the usual treatment suggested by
their physician along with any changes that the physician deems necessary during the 3
month period of this study. They will continue to eat their usual diet as before their
enrollment. They shall however receive usual counseling on lifestyle modifications
including diet.
Data Collection The Following data shall be collected during the study Parameter Time
Height Baseline only Weight & BMI Baseline and end of study Appetite Weekly Satiety
Weekly Compliance with provided treatment Weekly BP Weekly Fasting Blood Sugar Weekly
Post Meal Sugar Weekly HbA1C Baseline and end of study Fasting Lipid Profile Baseline
and end of study Creatinine Baseline and end of study ALT Baseline and end of study
Parameter Time
Duration of the Study This project shall be completed in a period of 15 to 18 months,
and the time taken for each segment is expected to go as follows Phase -1 3 months
Phase-2 Enrollment 3 months Run-in (Washout) Period 2 weeks Treatment period 3 months
Lab work and data analysis 3 months Write -up 3 months Total Duration 15.5 months
Data Analysis Statistical analysis: The data shall be processed in SPSS 23. HbA1C, BMI,
Lipid profile, creatinine and ALT shall be for analysis of Variance (ANOVA), and weakly
changes in Fasting and post meal sugars, blood pressure, appetite, satiety and
compliance shall be evaluated through factorial analysis to assess the effect of
composite flour over time. Both analyses shall be conducted with a Significance Level at
P - value < 0.05 for all the parameters Expected outcomes: This study is expected to
show a significant improvement in glycemic control with a possible benefit in BP,
satiety, weight and
