A 12-week Pilot Randomized Controlled Trial of an Oral Nutritional Supplement in Improving the Nutritional and Health Outcomes of the Elderly in Peri Urban Communities of the La Nkwantanang Madina Municipality in the Greater Accra Region

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:

• Elderly individuals aged 60 years and above

• Consent to participate

Locations
Other Locations
Ghana
University of Ghana
RECRUITING
Accra
Contact Information
Primary
Matilda Anim-Fofie, MPhil in Nutrition
matildafofie@gmail.com
+233501259184
Backup
Gloria E. Otoo, PhD Nutrition
geotoo@yahoo.com
+233209535981
Time Frame
Start Date: 2025-11-24
Estimated Completion Date: 2026-04
Participants
Target number of participants: 80
Treatments
Experimental: Oral nutritional supplement
Participants will consume daily for 12 weeks in between meals, a 300 ml oral nutritional supplement
No_intervention: No treatment or the control group
The participants in the no treatment group or control group will not receive any treatment during the 12 weeks except for nutrition education that will be given at certain points to all the participants
Related Therapeutic Areas
Sponsors
Leads: University of Ghana

This content was sourced from clinicaltrials.gov