Efficacy Assessment of Gluten Free Cupcakes

University of Veterinary and Animal Sciences, Lahore - Pakistan

Status: Completed

Conditions: Celiac Disease in Children

Treatments: Dietary Supplement: nutrient rich food product; Dietary Supplement: food product

Study type: Interventional

Funder types: Other

Identifiers

NCT06359613

029/IRC/BMR

Details and patient eligibility

About

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).

Full 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)

Enrollment: 75 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups, including a placebo group

Gluten Free cupcake Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: nutrient rich food product

Placebo group

Placebo Comparator group

Description:

Cupcakes from usually used gluten free rice flour will be prepared. 2 cupcakes/ day, 35g each will be provided to participants for 12 weeks.

Treatment:

Dietary Supplement: food product