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

Healthy Ageing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03594097
• Other study ID #: HS21905 (B2018:052)
• Status: Terminated
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: April 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Ageing

Intervention

Other:
• Treatment cookies
Plain flour, Coconut Nourish, Queen Garnet Plum, Unsalted Butter, Artificial Sweetener
• Control cookies
Plain flour, Coconut Powder, Unsalted Butter, Artificial Sweetener, Food Colour

Locations

Country	Name	City	State
Australia	University of Southern Queensland	Toowoomba	Queensland
Canada	Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	University of Southern Queensland

Countries where clinical trial is conducted

Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lean mass	Measured using dual-energy x-ray absorptiometry (DXA)	8 weeks
Secondary	Body weight		8 weeks
Secondary	Body mass index	Weight and height will be combined to report BMI in kg/m^2	8 weeks
Secondary	Waist circumference		8 weeks
Secondary	Arm circumference		8 weeks
Secondary	Wrist circumference		8 weeks
Secondary	Calf circumference		8 weeks
Secondary	Triceps skinfold		8 weeks
Secondary	Five times chair standing test		8 weeks
Secondary	Handgrip dynamometer		8 weeks
Secondary	Blood pressure	Systolic and diastolic pressure will be assessed	8 weeks
Secondary	Heart rate		8 weeks
Secondary	Bone mineral density	Measured using DXA	8 weeks
Secondary	Bone mineral content	Measured using DXA	8 weeks
Secondary	Fat mass	Measured using DXA	8 weeks
Secondary	Blood total cholesterol		8 weeks
Secondary	Blood low-density lipoprotein cholesterol		8 weeks
Secondary	Blood high-density lipoprotein cholesterol		8 weeks
Secondary	Blood triglycerides		8 weeks
Secondary	Blood glucose		8 weeks
Secondary	Blood C-reactive protein		8 weeks
Secondary	Blood interleukin 1 beta		8 weeks
Secondary	Blood tumor necrosis factor alpha		8 weeks