Composite Flour Cookies for Improving Nutrition in Malnourished Children

NCT07504133 | Completed

• 1 other identifier: PMAS-COOKIE-RCT-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malnutrition (Calorie); Protein-energy Malnutrition

Keywords

Malnutrition; Child Nutrition; Dietary Intervention; Composite Flour cookies; Nutritional Supplementation

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (5)

• Sensory Acceptability Score

  Baseline

• Physical Properties

  Baseline

• Phytochemical Composition

  Baseline

• Mineral Content

  Baseline

• Proximate Composition

  Baseline

Study Arms (2)

Composite Cookie Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Composite Flour Cookies DIETARY_SUPPLEMENT

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.

Composite Cookie Group

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mairaj Noor: lead

Study Sites (1)

Bilal Hospital Rawalpindi

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Malnutrition; Protein-Energy Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Protein Deficiency; Deficiency Diseases

Study Officials

• Mairaj Noor, Masters in Science (MS)

  Pir Mehr Ali Shah Arid Agriculture University Rawalpindi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was conducted as an open-label trial with no masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned into two groups: an intervention group receiving composite flour cookies and a control group receiving a regular diet without supplementation.

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 31, 2026
• Study Start: May 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)