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Recruiting Phase 1 NCT06773975

The Effect of an Oral Nutritional Supplement on the Nutritional and Health Outcomes of the Elderly

Trial Parameters

Condition Hypertension
Sponsor University of Ghana
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 80
Sex ALL
Min Age 60 Years
Max Age N/A
Start Date 2025-11-24
Completion 2026-04
Interventions
Oral nutritional supplementation

Brief Summary

I am conducting this research to find out if a peanut based food that is ready to use would improve the nutritional and health outcomes of the elderly when they consume it daily for 12 weeks. Eligible participants will be assigned randomly to any of these 2 groups. 1. To consume the food once a day in between meals in addition to their usual food for 12 weeks (3 months) or 2. A control group that will not be given the food. Measurements such as weight, blood pressure and the hand grip strength will be taken at the certain points of the study. A sterile needle will be used to draw about 5 ml of venous blood (from the arm) at the beginning of the study and after 12 weeks. Analyses would be carried out on the blood to know if the food has made an impact on serum albumin, ferritin, haemoglobin and cholesterol. If the findings of the study are favourable, it would provide insights for a larger randomized controlled trial that could establish the efficacy of a locally produced peanut based food for the feeding of the elderly.

Eligibility Criteria

Inclusion Criteria: * Elderly individuals aged 60 years and above * Consent to participate Exclusion Criteria: * Peanut allergy * Millet allergy * Sesame seeds allergy * The use of oral nutritional supplement * Sickle cell disease * End stage and terminal illness (cancer, stroke, liver disease, dialysis) * Clinical depression * Speech impairment * Hearing impairment * Visual impairment * Cognitive impairment Screening/for cognitive impairment; the Abbreviated Mental Test Score by HODKINSON (1972) was adapted for use.

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