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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy Ageing
• Intervention / Treatment: Other: Treatment cookies; Other: Control cookies

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Toowoomba, Queensland, Australia, 4350
      • University of Southern Queensland
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 6C5
      • Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment cookies	Other: Treatment cookies; Plain flour, Coconut Nourish, Queen Garnet Plum, Unsalted Butter, Artificial Sweetener
Active Comparator: Control cookies	Other: Control cookies; Plain flour, Coconut Powder, Unsalted Butter, Artificial Sweetener, Food Colour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lean mass	Measured using dual-energy x-ray absorptiometry (DXA)	8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: University of Southern Queensland
• Investigators: Principal Investigator: Peter Jones, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HS21905 (B2018:052)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No