Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359613
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2024-03-29
Brief Title:
Efficacy Assessment of Gluten Free Cupcakes
Sponsor:
University of Veterinary and Animal Sciences Lahore - Pakistan
Organization:
University of Veterinary and Animal Sciences Lahore - Pakistan
Study Overview
Official Title:
Development and Efficacy Assessment of Aglutenic Product to Improve the Nutritional Status of Celiac Children
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized controlled trial will be conducted after getting informed consent form from each study participant meeting inclusion criteria n70 35 control group 35 intervention group 3-8years of age After consumer acceptance against various attributes of aglutenic cupcake the product will be provided in polyethylene bags containing 28 cupcakes 35gm by weightcupcake 2 cupcakes for each day providing approximately 20 daily value DV of energy Cupcakes of equal weight and size made with rice flour mostly used recipe will be provided to the control group Further product will be provided on follow-up visits The compliance to a gluten free diet GFD and supplemented product will be confirmed by a Food Frequency Questionnaire FFQ
Detailed Description:
Raw Material Preparation of flour blends for aglutenic gluten free cupcakes
Sorghum chickpea Flaxseed and Almond rich in healthy nutrients will be purchased from the local market All these ingredients was ground into fine powder using uncontaminated grinder Different flour blends was prepared by substituting whole wheat flour with Sorghum Chickpea Flaxseed and Almond flour at different replacement levels
The efficacy study protocol was approved by the Bioethics Committee for randomized controlled trial RCT Written informed consent was obtained by the parents of children or their legal guardian
Target population Celiac Diseasegluten sensitive patients n 70 35 control 35 intervention was recruited according to European Society for Pediatric Gastroenterology Hepatology and Nutrition ESPGHAN criteria
Inclusion criteria
In accordance with the inclusion criteria boys and girls suffering from celiac disease was recruited
Positive trans-glutaminase antibody tTG as currently recommended test is the serum Immunoglobulin A IgA tissue trans-glutaminase antibody tTG The test has a sensitivity and specificity of greater than 90
Clinical response to gluten free diet
In the age range of 3-8 years
Exclusion Criteria
Patients on any other designed diet
Taking vitamins and mineral supplements
Individuals presenting with any other intestinal inflammatory disease malignant diseases chronic infections thyroid renal or hepatic alterations
Taking drugs known to effect lipid and or carbohydrate metabolism will be excluded from the study
Effect of interventional product on nutritional status of participants will be assessed through anthropometric measurements gastrointestinal complaints and following hematological indices
Complete Blood Count CBC WBCs RBCs MCV Hb Hct Platelets
Total Protein
Lipid Profile HDL LDL VLDL Cholesterol
SGPT SGOT
Serum Electrolytes Na Ca K
Sorghum chickpea Flaxseed and Almond rich in healthy nutrients will be purchased from the local market All these ingredients was ground into fine powder using uncontaminated grinder Different flour blends was prepared by substituting whole wheat flour with Sorghum Chickpea Flaxseed and Almond flour at different replacement levels
The efficacy study protocol was approved by the Bioethics Committee for randomized controlled trial RCT Written informed consent was obtained by the parents of children or their legal guardian
Target population Celiac Diseasegluten sensitive patients n 70 35 control 35 intervention was recruited according to European Society for Pediatric Gastroenterology Hepatology and Nutrition ESPGHAN criteria
Inclusion criteria
In accordance with the inclusion criteria boys and girls suffering from celiac disease was recruited
Positive trans-glutaminase antibody tTG as currently recommended test is the serum Immunoglobulin A IgA tissue trans-glutaminase antibody tTG The test has a sensitivity and specificity of greater than 90
Clinical response to gluten free diet
In the age range of 3-8 years
Exclusion Criteria
Patients on any other designed diet
Taking vitamins and mineral supplements
Individuals presenting with any other intestinal inflammatory disease malignant diseases chronic infections thyroid renal or hepatic alterations
Taking drugs known to effect lipid and or carbohydrate metabolism will be excluded from the study
Effect of interventional product on nutritional status of participants will be assessed through anthropometric measurements gastrointestinal complaints and following hematological indices
Complete Blood Count CBC WBCs RBCs MCV Hb Hct Platelets
Total Protein
Lipid Profile HDL LDL VLDL Cholesterol
SGPT SGOT
Serum Electrolytes Na Ca K
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None