Efficacy Assessment of Gluten Free Cupcakes

Celiac Disease in Children Clinical Trial

Official title:

Development and Efficacy Assessment of Aglutenic Product to Improve the Nutritional Status of Celiac Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06359613
• Other study ID #: 029/IRC/BMR
• Status: Completed
• Phase: N/A
• Start date: October 3, 2019
• Est. completion date: January 3, 2020

Study information

• Verified date: April 2024
• Source: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 3, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease
• Celiac Disease in Children

Intervention

Dietary Supplement:
• nutrient rich food product
Cupcakes from flour blends of Sorghum, chickpea, Flaxseed and Almond will be prepared and flour concentration will be so adjusted to provide >20% daily value of nutrients for children of 3-8 years of age. 2 cupcakes/ day, 35g each will be provided to participants for 12 weeks.
• food product
Cupcakes from usually used gluten free rice flour will be prepared. 2 cupcakes/ day, 35g each will be provided to participants for 12 weeks.

Locations

Country	Name	City	State
Pakistan	UVAS	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Veterinary and Animal Sciences, Lahore - Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight	Body weight (in kilograms) will be measured using a weight machine with standardization done after every 20 readings.	12 weeks
Primary	Height of the patients	Height (in centimeters) will be measured (without shoes) in the position, back and hips touching the wall by using wall mounted stedio-meter	12 weeks
Primary	Mid upper Arm Circumference (MUAC)	Mid-upper arm circumference (MUAC) in centimeters will be measured midpoint between the acromion process of the scapula and the tip of the elbow.	12 weeks
Primary	Body Mass Index (BMI)	BMI will be calculated by using standard formula as weight in kilograms divided by height in meter square kg/m2. World Health Organization (WHO) standard growth charts, designed separately for boys and girls will be used as a research tool to assess the nutritional status.	12 weeks
Primary	Complete Blood Count (CBC)	White Blood Cells 10^9/L Red Blood Cells million/mm3 Mean Corpuscular Volume 10^6/µL Hemoglobin g/dL Hematocrit % Platelets 10^9/L	12 weeks
Primary	Total Protein	Serum Total Protein g/dL	12 weeks
Primary	Lipid Profile	High Density Lipoproteins mg/dL Low Density Lipoproteins mg/dL Very Low-Density Lipoproteins mg/dL Serum Total Cholesterol mg/dL	12 weeks
Primary	Liver Enzymes	serum glutamic-pyruvic transaminase SGPT- U/L, serum glutamic-oxaloacetic transaminase SGOT-U/L	12 weeks
Primary	Serum Electrolytes	Sodium mmol/L Calcium mg/dL Potassium mmol/L	12 weeks
Secondary	Gastrointestinal Symptoms	Rate of diarrhea, constipation, Severity of abdominal pain, steatorrhea, flatulence and appetite will be monitored by using Gastrointestinal Rating Scale with addition of Steatorrhea.	12 weeks