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RECRUITINGPhase 1INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Elderly individuals aged 60 years and above - Consent to participate Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIETARY_SUPPLEMENT

Oral nutritional supplementation

The oral nutritional supplement is a locally made plant based formulation targeted to improve the nutritional status of the elderly

Locations (1)

University of Ghana
Accra, Greater Accra Region, Ghana