Clinical trial NCT03594097: Use of Coconut Nourish and Queen Garnet Plum to Improve Health in an Elderly Population
Official title: Use of Coconut Nourish and Queen Garnet Plum to Improve Health in an Elderly Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Ageing
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: University of Southern Queensland
First posted: 2018-07-20
Enrollment: 7
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Lean mass
timeFrame: 8 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 8 weeks
measure: Body mass index
timeFrame: 8 weeks
measure: Waist circumference
timeFrame: 8 weeks
measure: Arm circumference
timeFrame: 8 weeks
measure: Wrist circumference
timeFrame: 8 weeks
measure: Calf circumference
timeFrame: 8 weeks
measure: Triceps skinfold
timeFrame: 8 weeks
measure: Five times chair standing test
timeFrame: 8 weeks
measure: Handgrip dynamometer
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
measure: Heart rate
timeFrame: 8 weeks
measure: Bone mineral density
timeFrame: 8 weeks
measure: Bone mineral content
timeFrame: 8 weeks
measure: Fat mass
timeFrame: 8 weeks
measure: Blood total cholesterol
timeFrame: 8 weeks
measure: Blood low-density lipoprotein cholesterol
timeFrame: 8 weeks
measure: Blood high-density lipoprotein cholesterol
timeFrame: 8 weeks
measure: Blood triglycerides
timeFrame: 8 weeks
measure: Blood glucose
timeFrame: 8 weeks
measure: Blood C-reactive protein
timeFrame: 8 weeks
measure: Blood interleukin 1 beta
timeFrame: 8 weeks
measure: Blood tumor necrosis factor alpha
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toowoomba
country: Australia
facility: University of Southern Queensland
state: Queensland
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Peter Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: