Malnutrition (Calorie), Protein-energy Malnutrition
Conditions
Keywords
Malnutrition, Child Nutrition, Dietary Intervention, Composite Flour cookies, Nutritional Supplementation
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.
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.
Interventions
DIETARY_SUPPLEMENTComposite 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.
Sponsors
Mairaj Noor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This study was conducted as an open-label trial with no masking.
Intervention model description
Participants were randomly assigned into two groups: an intervention group receiving composite flour cookies and a control group receiving a regular diet without supplementation.
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight-for-Age Z-score (WAZ) | 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 |
| Change in Height-for-Age Z-score (HAZ) | 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. |
| Change in BMI-for-Age Z-score (BAZ) | 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 |
| Change in Mid-Upper Arm Circumference (MUAC) | 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 |
| Change in Serum Albumin Levels | 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 |
| Change in Hemoglobin | 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 |
| Change in Physical Signs of Malnutrition | 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 |
| Change in Daily Energy Intake | 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 |
| Change in Daily Protein Intake | Baseline and monthly up to 3 months | Daily protein intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software |
| Change in Daily Carbohydrate Intake | Baseline and monthly up to 3 months | Daily carbohydrate intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software |
| Change in Daily Fat Intake | Baseline and monthly up to 3 months | Daily fat intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software |
| Change in Appetite Score | 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 |
| Change in Energy and Fatigue Levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Sensory Acceptability Score | 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 |
| Physical Properties | Baseline | Diameter (mm), thickness (mm), and spread ratio measured using standard AACC (2000) methods |
| Phytochemical Composition | 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 |
| Mineral Content | Baseline | Iron, calcium, zinc, magnesium, and phosphorus (mg/100 g) determined using AOAC (2012) methods and atomic absorption spectrophotometry |
| Proximate Composition | Baseline | Moisture, protein, fat, ash, fiber, and carbohydrate content (%) determined using standard methods (AACC, 2000) |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORMairaj Noor, Masters in Science (MS)
Pir Mehr Ali Shah Arid Agriculture University Rawalpindi
Outcome results
None listed