Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2019-10-03
2020-01-03
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Clinical response to gluten free diet
Exclusion Criteria
* 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
3 Years
8 Years
ALL
No
Sponsors
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University of Veterinary and Animal Sciences, Lahore - Pakistan
OTHER
Responsible Party
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Shaista Jabeen
Principal Investigator
Principal Investigators
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Shaista Jabeen
Role: PRINCIPAL_INVESTIGATOR
University of Veterinay and Animal Sciences,Lahore,Pakistan
Locations
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UVAS
Lahore, Punjab Province, Pakistan
Countries
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References
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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.
Other Identifiers
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029/IRC/BMR
Identifier Type: -
Identifier Source: org_study_id
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