Clinical trial NCT06773975: The Effect of an Oral Nutritional Supplement on the Nutritional and Health Outcomes of the Elderly
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Hypertension
Hand Grip Strength
Body Weight
Iron Deficiency
Anaemia
Total Cholesterol
Protein Deficiency
Keywords: Nutritional and health outcomes
Oral Nutritional Supplement
Elderly
Peri urban
Randomized Controlled Trial
Lead sponsor: University of Ghana
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Study design A hybrid study comprising of a cross sequential study and a randomized controlled trial.

Study area The study locations are the following five peri urban communities out of the ten peri urban communities in the La Nkwantanang Madina Municipality (LANMA) of the Greater Accra Region in Ghana; Ayi Mensah, Kweiman, Danfa, Adoteiman and Otinibi. These have been conveniently selected because they are a continuous stretch of five communities in the order listed above to reduce the cost of transportation of data collectors and logistics, distribution of the intervention and data collection based on funds available for the project.

Sample size Assumptions: A Cohen's medium effect size of 0.3, a statistical power of 80% at a 5% level of significance, G-power 3.9.1.7 software generated a sample size of 90 participants per treatment group. Accounting for attrition rate + loss to follow up of 10% = 99 participants \* 2 treatment groups

= A total sample size of 198 elderly individuals. This has been rounded off to 200 participants. The census to recruit the 200 eligible participants has been completed as of December 13, 2024.

A cross-sectional survey to identify the relationship between usual dietary intake, handgrip strength and blood pressure has been conducted for the 200 participants. Eighty of the participants will be randomly selected as participants for a 12 week randomized control trial.

Assumptions (80 participants): Billingham et al. (2013) after studying the sample sizes of feasibility and pilot randomized controlled trials from the database of the United Kingdom Clinical Research Network (UKCRN), found that trials with a dichotomous endpoint had a median sample size of 36 per arm, ranging from 10 to 300 participants and for continuous endpoint, a median sample size of 30 participants, ranging from 8 to 114 participants.

Data collection for the randomized control trial An interviewer administered questionnaire will be used to obtain the following information at different points of assessments

Baseline data collection Sociodemographic characteristics and medical history such as age, sex, highest level of education, marital status, ethnicity and use of iron supplements, anti-hypertensive drugs and cholesterol lowering drugs will be collected.

Baseline, midline (6 weeks) and endline (12 weeks) A multiple pass quantitative 24-hour dietary recall to obtain information on usual dietary intake. Household measures and food models will be used to estimate portion sizes. The Physical Activity Scale for the Elderly (PASE) by Washburn et al. (1993) will be used to measure level of physical activity. Body weight, hand grip strength, systolic and diastolic blood pressure will be measured.

Weekly Information on adherence will be collected by evidence of pouches of previous week's ration to calculate percentage of quantity consumed. The 24-hour dietary recall will also be used to track adherence. Information on morbidity on the use of oral nutritional supplements will be collected using the questionnaire for gastrointestinal problems adapted from Pereira et al. (2014).

Baseline and 12 weeks A qualified phlebotomist will take a 5ml venous blood for analyses of the following: serum albumin, serum ferritin, serum cholesterol and haemoglobin

The intervention A 7-day ration of the oral nutritional supplement will be distributed to the intervention arm once a week. A day's serving of 330 ml is to be consumed in between meals. After endline data collection, the control arm will be given a ration of the oral nutritional supplement that will be enough for one month.

Statistical analyses

* To investigate the effect of sociodemographic characteristics, dietary intake and level of physical activity on the outcome measures, binary logistic regression for categorical variables, multinomial or ordinal logistics regression for multiple variables and linear regression for continuous variables
* To determine the efficacy of the oral nutritional supplement on outcome measures within the same treatment arm, repeated measures ANOVA and paired-sample t-test will be used
* To determine the differences in outcomes between the treatment groups the multivariate ANOVA and independent sample t-test will be used.

Data entry and management Field investigators will enter data collected on pre-programmed tablets that are functioning well. After each day's work, the supervisor will cross check and review all data in the presence of field investigators to ensure that complete and consistent data is finally submitted. The supervisor will flag any aberrant values and consult with the relevant field worker within 24 hours so that gaps will be filled, errors resolved and repeat interviews/visits can be conducted if need be. The submitted data will be accessed by the principal investigator daily for real-time review and monitoring. Once all data have been entered, reviewed and cleaned, final SPSS datasets will be generated and made available to the principal investigator for analysis. As soon as the manuscripts summarizing the study's primary outcomes are published, all datasets will be made available to any one who request it for research purposes.

Informed consent forms will be stored under lock and key.

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.

Primary outcomes:
measure: Concentration of serum albumin in g/dL; a change in the concentration of serum albumin from baseline to 12 weeks
timeFrame: Measurement will be taken at baseline (before commencement of intervention) and after 12 weeks of intervention
measure: 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
timeFrame: At baseline, midline (6 weeks) and endline (12 weeks)
Secondary outcomes:
measure: Haemoglobin level in g/dl to determine the prevalence of anaemia at baseline and after 12 weeks
timeFrame: Haemoglobin level measured at baseline (before the intervention) and after 12 weeks
measure: Concentration of serum ferritin in µg/l to determine the prevalence of iron deficiency at baseline and at 12 weeks
timeFrame: Baseline and after 12 weeks
measure: Total serum cholesterol measured in mg/dL at baseline and at 12 weeks to determine the change in total serum cholesterol
timeFrame: Baseline and after 12 weeks
measure: 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)
timeFrame: At baseline, midline (6 weeks) and endline (12 weeks)
measure: 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)
timeFrame: At baseline, midline (6 weeks) and endline (12 weeks)
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: University of Ghana
state: Greater Accra Region
Study officials:
affiliation: University of Ghana
name: Gloria E. Otoo, PhD in Nutrition
role: STUDY_DIRECTOR
affiliation: University of Ghana
name: Matilda Steiner-Asiedu, PhD in Nutrition
role: STUDY_DIRECTOR
affiliation: Council for Scientific and Industrial Research-Food Research Institute, Accra-Ghana
name: Jolene Nyako, PhD in Nutrition
role: STUDY_DIRECTOR
affiliation: University of Ghana
name: Firibu K. Saalia, PhD in Food Science
role: STUDY_DIRECTOR
References:
citation: Billingham et al. 2013
citation: 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.