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Efficacy Assessment of Gluten Free Cupcakes

NCT06359613 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-04-22

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Veterinary and Animal Sciences, Lahore - Pakistan

    lead OTHER

Principal Investigators

  • Shaista Jabeen · University of Veterinay and Animal Sciences,Lahore,Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-03
Primary Completion
2019-12-15
Completion
2020-01-03

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06359613 on ClinicalTrials.gov