Clinical trial NCT06359613: Efficacy Assessment of Gluten Free Cupcakes
Official title: Development and Efficacy Assessment of Aglutenic Product to Improve the Nutritional Status of Celiac Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease in Children
Keywords: gluten sensitivity children nutritional status food choices
Lead sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The product will be provided to intervention group (n=50) in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2/day) providing approximately 20%DV of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group (n=50)
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized controlled trial will be conducted after getting informed consent form from each study participant meeting inclusion criteria (n=70, 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 weight/cupcake, 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 Disease/gluten 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)

Eligibility criteria: Inclusion Criteria:

* Positive tissue trans-glutaminase antibody (tTG)
* Clinical response to gluten free diet

Exclusion Criteria:

* Vitamins and mineral supplements
* Intestinal inflammatory diseases
* Malignant diseases of intestines
* Chronic infections,
* Thyroid, renal or hepatic alterations
* Celiac patients with diabetes
* Taking drugs known to effect lipid and /or carbohydrate metabolism

Primary outcomes:
measure: Body Weight
timeFrame: 12 weeks
measure: Height of the patients
timeFrame: 12 weeks
measure: Mid upper Arm Circumference (MUAC)
timeFrame: 12 weeks
measure: Body Mass Index (BMI)
timeFrame: 12 weeks
measure: Complete Blood Count (CBC)
timeFrame: 12 weeks
measure: Total Protein
timeFrame: 12 weeks
measure: Lipid Profile
timeFrame: 12 weeks
measure: Liver Enzymes
timeFrame: 12 weeks
measure: Serum Electrolytes
timeFrame: 12 weeks
Secondary outcomes:
measure: Gastrointestinal Symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: UVAS
state: Punjab
Study officials:
affiliation: University of Veterinay and Animal Sciences,Lahore,Pakistan
name: Shaista Jabeen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suliburska J, Krejpcio Z, Regula J, Grochowicz A. Evaluation of the content and the potential bioavailability of minerals from gluten-free products. Acta Sci Pol Technol Aliment. 2013 Jan-Mar;12(1):75-9.