Efficacy Assessment of Gluten Free Cupcakes

April 18, 2024 updated by: Shaista Jabeen, University of Veterinary and Animal Sciences, Lahore - Pakistan

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • UVAS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gluten Free cupcake Group
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
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.
Placebo Comparator: Placebo group
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
Cupcakes from usually used gluten free rice flour will be prepared. 2 cupcakes/ day, 35g each will be provided to participants for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: 12 weeks
Body weight (in kilograms) will be measured using a weight machine with standardization done after every 20 readings.
12 weeks
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
12 weeks
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.
12 weeks
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.
12 weeks
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
12 weeks
Total Protein
Time Frame: 12 weeks
Serum Total Protein g/dL
12 weeks
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
12 weeks
Liver Enzymes
Time Frame: 12 weeks
serum glutamic-pyruvic transaminase SGPT- U/L, serum glutamic-oxaloacetic transaminase SGOT-U/L
12 weeks
Serum Electrolytes
Time Frame: 12 weeks
Sodium mmol/L Calcium mg/dL Potassium mmol/L
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan

Investigators

  • Principal Investigator: Shaista Jabeen, University of Veterinay and Animal Sciences,Lahore,Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2019

Primary Completion (Actual)

December 15, 2019

Study Completion (Actual)

January 3, 2020

Study Registration Dates

First Submitted

March 29, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 029/IRC/BMR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

study outcomes will be shared with other researchers through publication without personal identification

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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