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Completed

NCT Number: NCT07504133

Composite Flour Cookies for Improving Nutrition in Malnourished Children

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.

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Key information

Conditions

Malnutrition (Calorie) Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Protein Deficiency Protein-Energy Malnutrition

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bilal Hospital Rawalpindi

Rawalpindi, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Weight-for-Age Z-score (WAZ)

    Time frame: Baseline and monthly up to 3 months

    Change in weight-for-age Z-score calculated using WHO Child Growth Standards based on measured body weight (kg) from baseline to 3 months

  2. Change in Height-for-Age Z-score (HAZ)

    Time frame: Baseline and monthly up to 3 months

    Change in height-for-age Z-score calculated using WHO Child Growth Standards based on measured height (cm) from baseline to 3 months.

  3. Change in BMI-for-Age Z-score (BAZ)

    Time frame: Baseline and monthly up to 3 months

    Change in BMI-for-age Z-score calculated using WHO Child Growth Standards based on BMI (kg/m²) from baseline to 3 months

  4. Change in Mid-Upper Arm Circumference (MUAC)

    Time frame: Baseline and monthly up to 3 months

    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

  5. Change in Serum Albumin Levels

    Time frame: Baseline and monthly over a 3-month period

    Change in serum albumin concentration (g/dL) measured using standard biochemical laboratory methods at baseline and at 3 months

  6. Change in Hemoglobin

    Time frame: Baseline and monthly up to 3 months

    Change in hemoglobin levels (g/dL) measured using standard laboratory methods from baseline to 3 months to assess anemia status

  7. Change in Physical Signs of Malnutrition

    Time frame: Baseline and monthly up to 3 months

    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

  8. Change in Daily Energy Intake

    Time frame: Baseline and monthly up to 3 months

    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

  9. Change in Daily Protein Intake

    Time frame: Baseline and monthly up to 3 months

    Daily protein intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software

  10. Change in Daily Carbohydrate Intake

    Time frame: Baseline and monthly up to 3 months

    Daily carbohydrate intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software

  11. Change in Daily Fat Intake

    Time frame: Baseline and monthly up to 3 months

    Daily fat intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software

  12. Change in Appetite Score

    Time frame: Baseline and monthly up to 3 months

    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

  13. Change in Energy and Fatigue Levels

    Time frame: Baseline and monthly up to 3 months

    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)

Secondary outcomes

  1. Sensory Acceptability Score

    Time frame: Baseline

    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

  2. Physical Properties

    Time frame: Baseline

    Diameter (mm), thickness (mm), and spread ratio measured using standard AACC (2000) methods

  3. Phytochemical Composition

    Time frame: Baseline

    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

  4. Mineral Content

    Time frame: Baseline

    Iron, calcium, zinc, magnesium, and phosphorus (mg/100 g) determined using AOAC (2012) methods and atomic absorption spectrophotometry

  5. Proximate Composition

    Time frame: Baseline

    Moisture, protein, fat, ash, fiber, and carbohydrate content (%) determined using standard methods (AACC, 2000)

Sponsors and collaborators

Lead sponsor

Mairaj Noor

Other

Registry information

Official study title

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

Acronym: CFC-MAL

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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