Composite Flour Cookies for Improving Nutrition in Malnourished Children (CFC-MAL)

Mairaj Noor

Status: Completed

Conditions: Protein-energy Malnutrition; Malnutrition (Calorie)

Treatments: Dietary Supplement: Composite Flour Cookies

Study type: Interventional

Funder types: Other

Identifiers

NCT07504133

PMAS-COOKIE-RCT-2024

Details and patient eligibility

About

Malnutrition is a major public health concern among children in developing countries, leading to impaired growth and increased risk of morbidity. This study evaluated the effectiveness of nutrient-dense composite flour cookies as a dietary intervention to improve the nutritional status of malnourished children.

Composite cookies were developed using soy, chickpea, and peanut, and were subjected to nutritional and quality analysis including proximate composition and other physicochemical assessments prior to intervention. A randomized controlled trial was conducted among 60 malnourished children aged 3 to 10 years, divided into intervention and control groups.

The intervention group received the composite cookies along with their regular diet, while the control group continued with their usual diet. Anthropometric indicators including weight, body mass index (BMI), and mid-upper arm circumference (MUAC), as well as biochemical parameters such as hemoglobin and serum albumin, were assessed at baseline and after a 3-month intervention period.

The study aimed to determine whether supplementation with nutrient-rich composite cookies could significantly improve growth and nutritional outcomes in malnourished children.

Full description

This randomized controlled trial was conducted to evaluate the impact of composite flour-enriched cookies on the nutritional status of malnourished children. Malnutrition remains a critical public health issue, particularly in low-resource settings, necessitating the development of affordable and nutrient-rich food-based interventions.

Prior to the intervention, composite cookies were formulated using soy, chickpea, and peanut to enhance protein and energy density. The developed product was evaluated through comprehensive analysis, including proximate composition, physicochemical properties, and sensory evaluation, to ensure nutritional adequacy and acceptability.

The study included 60 children aged 3-10 years diagnosed with moderate to severe malnutrition. Participants were randomly assigned to either the intervention group or the control group. The intervention group received daily supplementation with the developed composite cookies, while the control group continued their usual diet without supplementation.

The intervention period lasted for three months. Anthropometric measurements, including weight-for-age, BMI-for-age, and mid-upper arm circumference (MUAC), were recorded at baseline and at the end of the intervention. In addition, biochemical parameters such as hemoglobin and serum albumin levels were assessed to evaluate improvements in nutritional and physiological status.

The primary objective was to assess improvement in anthropometric indicators, while secondary outcomes included changes in biochemical parameters and overall health status. The findings of this study support the potential use of locally produced, nutrient-dense functional foods as sustainable strategies to combat childhood malnutrition.

Enrollment: 60 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 3-10 years diagnosed with malnutrition .
• Children willing to participate in the study.
• Participants whose parents or guardians provided informed consent.
• Children attending the selected hospital for nutritional assessment.

Exclusion criteria

• Children with severe chronic illnesses or metabolic disorders.
• Children with food allergies to ingredients used in the composite cookies (wheat, soy, chickpea, peanut).
• Children receiving other nutritional supplements during the study period.
• Children with severe acute medical conditions requiring hospitalization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Composite Cookie Group

Experimental group

Description:

Participants in this group received daily supplementation with composite flour cookies prepared from 40% Wheat and 60% composite flour(soy, chickpea, and peanut) (T3) , along with their regular diet for a duration of three months.

Treatment:

Dietary Supplement: Composite Flour Cookies

Control Group

No Intervention group

Description:

Participants in this group continued their regular diet without receiving any nutritional supplementation during the study period.