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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Concentration of serum albumin in g/dL; a change in the concentration of serum albumin from baseline to 12 weeks
研究概览
简要总结
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.
- To consume the food once a day in between meals in addition to their usual food for 12 weeks (3 months) or
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elderly individuals aged 60 years and above
- •Consent to participate
排除标准
- •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.
研究组 & 干预措施
Oral nutritional supplement
Participants will consume daily for 12 weeks in between meals, a 300 ml oral nutritional supplement
干预措施: Oral nutritional supplementation (Dietary Supplement)
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
结局指标
主要结局
Concentration of serum albumin in g/dL; a change in the concentration of serum albumin from baseline to 12 weeks
时间窗: Measurement will be taken at baseline (before commencement of intervention) and after 12 weeks of intervention
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.
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
时间窗: At baseline, midline (6 weeks) and endline (12 weeks)
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
次要结局
- 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))
研究者
Matilda Anim-Fofie
Principal Investigator and a PhD candidate studying Nutrition at the Department of Nutrition and Food Science-University of Ghana
University of Ghana