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

NCT06773975 | Completed Phase 1 DMC

• 1 other identifier: ORTONSINTUGDNFSSFPEMATGLSTJOSA
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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. 1.To consume the food once a day in between meals in addition to their usual food for 12 weeks (3 months) or
2. 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.

Conditions

Hand Grip Strength; Body Weight; Iron Deficiency; Anaemia; Total Cholesterol; Hypertension; Protein Deficiency

Keywords

Nutritional and health outcomes; Oral Nutritional Supplement; Elderly; Peri urban; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Concentration of serum albumin in g/dL; a change in the concentration of serum albumin from baseline to 12 weeks

  A phlebotomist will draw 5 ml of venous blood in the morning after a 12 hour overnight fast from each participant for analysis in the laboratory. This will be done at baseline and after 12 weeks. Generally the reference values for serum albumin level is 3.5 g/dL to 5.5 g/dL, however there could be slight differences for the range depending on the laboratory. Analyses will be carried out to ascertain any change in serum albumin levels between baseline and at 12 weeks. Comparisons will be made to ascertain the differences between the serum albumin concentration of the experimental arm and the no intervention arm at baseline and at 12 weeks. Participants with a serum albumin concentration below the reference range will be classified as having low serum albumin concentration.

  Measurement will be taken at baseline (before commencement of intervention) and after 12 weeks of intervention

• Body weight measured in kilograms to determine the change in weight at 3 different points of measurements within the 12 weeks of commencement of intervention

  The participants will be weighed in light clothing and without shoes. They will be instructed to stand up straight as possible, with heels close together, legs straight as possible, arms at the sides and shoulders relaxed. Body weight will be recorded to the nearest 0.1 kg. Two weight readings will be taken, however a third reading will be taken if the first two readings differ by more than 0.1kilogram. Periodically, the scale will be calibrated for accuracy. Body weight of each participant will be measured at baseline (before the commencement of the intervention), 6 weeks and 12 weeks. Analyses will be done to find out the trend in change in the body weight along the 3 different points of measurement. Comparisons will be made between the experimental group and the no intervention group at each point of measurement

  At baseline, midline (6 weeks) and endline (12 weeks)

Secondary Outcomes (5)

• Haemoglobin level in g/dl to determine the prevalence of anaemia at baseline and after 12 weeks

  Haemoglobin level measured at baseline (before the intervention) and after 12 weeks

• Concentration of serum ferritin in µg/l to determine the prevalence of iron deficiency at baseline and at 12 weeks

  Baseline and after 12 weeks

• Total serum cholesterol measured in mg/dL at baseline and at 12 weeks to determine the change in total serum cholesterol

  Baseline and after 12 weeks

• Hand grip strength of the dominant arm measured in kilograms to determine the change in handgrip strength at 3 different points of measurements; At baseline, midline (6 weeks) and endline (12 weeks)

  At baseline, midline (6 weeks) and endline (12 weeks)

• Systolic and diastolic blood pressure measured in mmHg to determine the prevalence of elevated blood pressure at baseline, midline (6 weeks) and endline (12 weeks)

  At baseline, midline (6 weeks) and endline (12 weeks)

Study Arms (2)

Oral nutritional supplement

EXPERIMENTAL

Participants will consume daily for 12 weeks in between meals, a 300 ml oral nutritional supplement

Dietary Supplement: Oral nutritional supplementation

No treatment or the control group

NO INTERVENTION

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

Interventions

Oral nutritional supplementation DIETARY_SUPPLEMENT

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

Oral nutritional supplement

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elderly individuals aged 60 years and above
• Consent to participate

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ghana: lead

Study Sites (1)

University of Ghana

Accra, Greater Accra Region, Ghana

Location

Related Publications (2)

• Billingham et al. 2013

  BACKGROUND

• Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol. 1993 Feb;46(2):153-62. doi: 10.1016/0895-4356(93)90053-4.

  PMID: 8437031 BACKGROUND

MeSH Terms

Conditions

Hypertension; Body Weight; Iron Deficiencies; Anemia; Protein Deficiency

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Gloria E. Otoo, PhD in Nutrition

  University of Ghana

  STUDY DIRECTOR

• Matilda Steiner-Asiedu, PhD in Nutrition

  University of Ghana

  STUDY DIRECTOR

• Jolene Nyako, PhD in Nutrition

  Council for Scientific and Industrial Research-Food Research Institute, Accra-Ghana

  STUDY DIRECTOR

• Firibu K. Saalia, PhD in Food Science

  University of Ghana

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and a PhD candidate studying Nutrition at the Department of Nutrition and Food Science-University of Ghana

Model Details: The study participants will be randomized to two arms; one arm will be given a plant-based oral nutritional supplement for 12 weeks and the other arm (control) will not be given any treatment. An oral nutritional supplement arm and a no treatment arm.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: January 14, 2025
• Study Start: November 24, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: As soon as the manuscripts summarizing the study's outcomes are published, all datasets will be made available to any one who request it for research purposes (beginning 6 months after publication) with no end date
• Access Criteria: All publications will bear the email address of the principal investigator/corresponding author of the publication. Anyone who would want to obtain the IPD could contact the corresponding author or the principal investigator. The one making the request would submit a proposal of what he intends to use the data for and the type of analyses that would be done. All correspondence and submissions will be via email. Requests for sharing of IPD will be reviewed by the sponsors and collaborators of this study.

Locations

GH (1)