Use of Coconut Nourish and Queen Garnet Plum to Improve Health in an Elderly Population

Not Applicable

Terminated

• Conditions: Healthy Ageing
• Interventions: Other: Treatment cookies; Other: Control cookies

• Registration Number: NCT03594097
• Lead Sponsor: University of Manitoba

Brief Summary

The purpose of this study is to identify whether the combination of coconut Nourish and Queen Garnet plum are able to attenuate ageing-related complications, including muscle mass loss and inflammation. The study endpoints will measure muscle mass as the primary endpoint with blood lipids, glucose, blood pressure, and inflammatory markers serving as some of the secondary endpoints. As the two products are rich in dietary fibre and anthocyanins, respectively, the study outcome will help to understand role of these dietary components in improving complications that are seen quite frequently in elderly population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-20
• Study Start: 2018-09-04
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2021-04
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Aged 65 years and above
• Able to give written informed consent
• Able to read, write and speak English
• Body mass index less than or equal to 30 kg/m^2
• Either do not suffer from a chronic disease or, if suffering from a chronic disease, then key parameters (blood pressure, blood lipids concentration and blood glucose concentrations) are within the normal physiological range
• Either take no chronic medication or have been treated with a stable dosage of medication for at least 3 months as confirmed by family physician.
• Either take no supplements, or have been utilizing supplements in a stable and consistent dose for at least 3 months, and plan to continue taking a stable and consistent dose throughout the entire study.

Exclusion Criteria

• Smokers
• Consumption of more than 2 alcoholic drinks/day, or > 14 alcoholic beverages a week, or history of alcoholism or drug dependence
• Uncontrolled hypertension, recent stroke or myocardial infarction, hypothyroidism, diabetes mellitus or kidney disease
• Major disability or disorder requiring continuous medical attention and treatment such as chronic heart failure, liver disease, renal failure or cancer, chronic infections or major surgery within 6 months prior to randomization
• Despite taking medication, do not have values for key parameters (blood pressure, blood lipids concentration and blood glucose concentrations) within normal physiological ranges
• Fasting glucose ≥ 5.6 mmol/L
• Triglycerides ≥ 1.7 mmol/L
• Systolic and diastolic blood pressures ≥130/85 mmHg
• High-density lipoprotein cholesterol ≤1.0 mmol/L
• Have gained or lost >10 lbs in the previous 3 months, or plan to lose weight at any time during the study
• History of allergy to coconut, plum, plain flour, butter or milk
• Any planned surgeries during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment cookies	Treatment cookies	-
Control cookies	Control cookies	-

Primary Outcome Measures

Name	Time	Method
Lean mass	8 weeks	Measured using dual-energy x-ray absorptiometry (DXA)

Secondary Outcome Measures

Name	Time	Method
Wrist circumference	8 weeks
Blood total cholesterol	8 weeks
Triceps skinfold	8 weeks
Calf circumference	8 weeks
Arm circumference	8 weeks
Bone mineral density	8 weeks	Measured using DXA
Bone mineral content	8 weeks	Measured using DXA
Blood glucose	8 weeks
Body weight	8 weeks
Waist circumference	8 weeks
Handgrip dynamometer	8 weeks
Blood triglycerides	8 weeks
Blood C-reactive protein	8 weeks
Body mass index	8 weeks	Weight and height will be combined to report BMI in kg/m\^2
Blood interleukin 1 beta	8 weeks
Five times chair standing test	8 weeks
Blood pressure	8 weeks	Systolic and diastolic pressure will be assessed
Heart rate	8 weeks
Fat mass	8 weeks	Measured using DXA
Blood high-density lipoprotein cholesterol	8 weeks
Blood tumor necrosis factor alpha	8 weeks
Blood low-density lipoprotein cholesterol	8 weeks

Trial Locations

Locations (2)

University of Southern Queensland; 🇦🇺 Toowoomba, Queensland, Australia

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada