Efficacy Assessment of Gluten Free Cupcakes

NCT06359613 | Completed

• 1 other identifier: 029/IRC/BMR
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Celiac Disease in Children

Keywords

gluten sensitivity children nutritional status food choices

Outcome Measures

Primary Outcomes (9)

• Body Weight

  Body weight (in kilograms) will be measured using a weight machine with standardization done after every 20 readings.

  12 weeks

• 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

• 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

• 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

• 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

• Total Protein

  Serum Total Protein g/dL

  12 weeks

• 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

• Liver Enzymes

  serum glutamic-pyruvic transaminase SGPT- U/L, serum glutamic-oxaloacetic transaminase SGOT-U/L

  12 weeks

• Serum Electrolytes

  Sodium mmol/L Calcium mg/dL Potassium mmol/L

  12 weeks

Secondary Outcomes (1)

• Gastrointestinal Symptoms

  12 weeks

Study Arms (2)

Gluten Free cupcake Group

EXPERIMENTAL

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.

Dietary Supplement: nutrient rich food product

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: food product

Interventions

nutrient rich food product DIETARY_SUPPLEMENT

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.

Gluten Free cupcake Group

food product DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Veterinary and Animal Sciences, Lahore - Pakistan: lead

Study Sites (1)

UVAS

Lahore, Punjab Province, 54000, Pakistan

Location

Related 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.

  PMID: 24584867 BACKGROUND

MeSH Terms

Interventions

Food

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Shaista Jabeen

  University of Veterinay and Animal Sciences,Lahore,Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 11, 2024
• Study Start: October 3, 2019
• Primary Completion: December 15, 2019
• Study Completion: January 3, 2020
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)