CompletedNot Applicable

Composite Flour Cookies for Improving Nutrition in Malnourished Children

Pakistan60 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range

3 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline and monthly up to 3 months

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

Timeframe: Baseline and monthly up to 3 months

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

Timeframe: Baseline and monthly up to 3 months

Change in Mid-Upper Arm Circumference (MUAC)

Timeframe: Baseline and monthly up to 3 months

Change in Serum Albumin Levels

Timeframe: Baseline and monthly over a 3-month period

Change in Hemoglobin

Timeframe: Baseline and monthly up to 3 months

Change in Physical Signs of Malnutrition

Timeframe: Baseline and monthly up to 3 months

Trial details

NCT IDNCT07504133

SponsorMairaj Noor

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Malnutrition (Calorie) trials

Plain-language summary

Who can participate

Age range

3 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline and monthly up to 3 months

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

Timeframe: Baseline and monthly up to 3 months

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

Timeframe: Baseline and monthly up to 3 months

Change in Mid-Upper Arm Circumference (MUAC)

Timeframe: Baseline and monthly up to 3 months

Change in Serum Albumin Levels

Timeframe: Baseline and monthly over a 3-month period

Change in Hemoglobin

Timeframe: Baseline and monthly up to 3 months

Change in Physical Signs of Malnutrition

Timeframe: Baseline and monthly up to 3 months