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Completed

NCT Number: NCT06359613

Efficacy Assessment of Gluten Free Cupcakes

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).

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Key information

Conditions

Celiac Disease in Children

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UVAS

Lahore, Punjab Province, 54000, Pakistan

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Body Weight

    Time frame: 12 weeks

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

  2. Height of the patients

    Time frame: 12 weeks

    Height (in centimeters) will be measured (without shoes) in the position, back and hips touching the wall by using wall mounted stedio-meter

  3. Mid upper Arm Circumference (MUAC)

    Time frame: 12 weeks

    Mid-upper arm circumference (MUAC) in centimeters will be measured midpoint between the acromion process of the scapula and the tip of the elbow.

  4. Body Mass Index (BMI)

    Time frame: 12 weeks

    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.

  5. Complete Blood Count (CBC)

    Time frame: 12 weeks

    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

  6. Total Protein

    Time frame: 12 weeks

    Serum Total Protein g/dL

  7. Lipid Profile

    Time frame: 12 weeks

    High Density Lipoproteins mg/dL Low Density Lipoproteins mg/dL Very Low-Density Lipoproteins mg/dL Serum Total Cholesterol mg/dL

  8. Liver Enzymes

    Time frame: 12 weeks

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

  9. Serum Electrolytes

    Time frame: 12 weeks

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

Secondary outcomes

  1. Gastrointestinal Symptoms

    Time frame: 12 weeks

    Rate of diarrhea, constipation, Severity of abdominal pain, steatorrhea, flatulence and appetite will be monitored by using Gastrointestinal Rating Scale with addition of Steatorrhea.

Sponsors and collaborators

Lead sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 11, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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