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

Effect of Composite Flour-Enriched Cookies on Clinical Outcomes of Malnourished Children: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition (Calorie); Protein-energy Malnutrition
• Intervention / Treatment: Dietary supplement: Composite Flour Cookies

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan
      • Bilal Hospital Rawalpindi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Composite Cookie Group; 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.	Dietary supplement: Composite Flour Cookies; One serving(5 cookies) constituting 50g supplemented cookies (T3) were provided as a daily dietary supplement to improve nutritional status in malnourished children over a period of three months.
No Intervention: Control Group; Participants in this group continued their regular diet without receiving any nutritional supplementation during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight-for-Age Z-score (WAZ)	Change in weight-for-age Z-score calculated using WHO Child Growth Standards based on measured body weight (kg) from baseline to 3 months	Baseline and monthly up to 3 months
Change in Height-for-Age Z-score (HAZ)	Change in height-for-age Z-score calculated using WHO Child Growth Standards based on measured height (cm) from baseline to 3 months.	Baseline and monthly up to 3 months
Change in BMI-for-Age Z-score (BAZ)	Change in BMI-for-age Z-score calculated using WHO Child Growth Standards based on BMI (kg/m²) from baseline to 3 months	Baseline and monthly up to 3 months
Change in Mid-Upper Arm Circumference (MUAC)	Change in MUAC measured in centimeters (cm) using a non-stretchable MUAC tape from baseline to 3 months and interpreted according to WHO MUAC classification criteria	Baseline and monthly up to 3 months
Change in Serum Albumin Levels	Change in serum albumin concentration (g/dL) measured using standard biochemical laboratory methods at baseline and at 3 months	Baseline and monthly over a 3-month period
Change in Hemoglobin	Change in hemoglobin levels (g/dL) measured using standard laboratory methods from baseline to 3 months to assess anemia status	Baseline and monthly up to 3 months
Change in Physical Signs of Malnutrition	Assessment of clinical signs of malnutrition (e.g., muscle wasting, hair thinning, pale skin) using clinical examination based on PYMS criteria Unit of Measure: Presence/absence	Baseline and monthly up to 3 months
Change in Daily Energy Intake	Daily energy intake (kcal/day) assessed using Food Frequency Questionnaire (FFQ) at baseline and caregiver-maintained food diary during follow-up, analyzed using NutriSurvey software	Baseline and monthly up to 3 months
Change in Daily Protein Intake	Daily protein intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software	Baseline and monthly up to 3 months
Change in Daily Carbohydrate Intake	Daily carbohydrate intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software	Baseline and monthly up to 3 months
Change in Daily Fat Intake	Daily fat intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software	Baseline and monthly up to 3 months
Change in Appetite Score	Appetite level assessed using caregiver-reported dietary intake patterns and food diary records, including frequency and quantity of meals consumed Unit of Measure: Score / qualitative assessment	Baseline and monthly up to 3 months
Change in Energy and Fatigue Levels	Energy levels and fatigue assessed through caregiver-reported observations of child activity, alertness, and daily functioning Unit of Measure: Qualitative assessment (improved / no change / worsened)	Baseline and monthly up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Acceptability Score	Sensory evaluation of cookies including taste, texture, aroma, and overall acceptability assessed using a 9-point hedonic scale (1 = dislike extremely, 9 = like extremely). Evaluation conducted by a trained panel (n=12) under standard ethical guidelines	Baseline
Physical Properties	Diameter (mm), thickness (mm), and spread ratio measured using standard AACC (2000) methods	Baseline
Phytochemical Composition	Phytochemical constituents including total phenolic content (GAE/g), total flavonoid content (QE/g), saponins, isoflavones, and phytosterols (mg/100 g) determined using standard validated analytical methods	Baseline
Mineral Content	Iron, calcium, zinc, magnesium, and phosphorus (mg/100 g) determined using AOAC (2012) methods and atomic absorption spectrophotometry	Baseline
Proximate Composition	Moisture, protein, fat, ash, fiber, and carbohydrate content (%) determined using standard methods (AACC, 2000)	Baseline

Collaborators and Investigators

• Sponsor: Mairaj Noor
• Investigators: Principal Investigator: Mairaj Noor, Masters in Science (MS), Pir Mehr Ali Shah Arid Agriculture University Rawalpindi

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Malnutrition; Dietary Intervention; Child Nutrition; Nutritional Supplementation; Composite Flour cookies
• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Protein Deficiency; Nutritional and Metabolic Diseases; Malnutrition; Protein-Energy Malnutrition
• Other Study ID Numbers: PMAS-COOKIE-RCT-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations of pediatric participants. Data are stored securely and were collected solely for academic research purposes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No