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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | No Intervention | Participants in this group continued their regular diet without receiving any nutritional supplementation during the study period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mairaj Noor, Masters in Science (MS) | Pir Mehr Ali Shah Arid Agriculture University Rawalpindi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bilal Hospital Rawalpindi | Rawalpindi | Punjab Province | Pakistan |
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.
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D011502 | Protein-Energy Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011488 | Protein Deficiency |
| D003677 | Deficiency Diseases |
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Participants were randomly assigned into two groups: an intervention group receiving composite flour cookies and a control group receiving a regular diet without supplementation.
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This study was conducted as an open-label trial with no masking.
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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 |
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 |