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

March 16, 2023 updated by: University of Manitoba
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lean mass
Time Frame: 8 weeks
Measured using dual-energy x-ray absorptiometry (DXA)
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Waist circumference
Time Frame: 8 weeks
8 weeks
Body weight
Time Frame: 8 weeks
8 weeks
Blood total cholesterol
Time Frame: 8 weeks
8 weeks
Blood low-density lipoprotein cholesterol
Time Frame: 8 weeks
8 weeks
Blood high-density lipoprotein cholesterol
Time Frame: 8 weeks
8 weeks
Blood triglycerides
Time Frame: 8 weeks
8 weeks
Blood glucose
Time Frame: 8 weeks
8 weeks
Body mass index
Time Frame: 8 weeks
Weight and height will be combined to report BMI in kg/m^2
8 weeks
Arm circumference
Time Frame: 8 weeks
8 weeks
Wrist circumference
Time Frame: 8 weeks
8 weeks
Calf circumference
Time Frame: 8 weeks
8 weeks
Triceps skinfold
Time Frame: 8 weeks
8 weeks
Five times chair standing test
Time Frame: 8 weeks
8 weeks
Handgrip dynamometer
Time Frame: 8 weeks
8 weeks
Blood pressure
Time Frame: 8 weeks
Systolic and diastolic pressure will be assessed
8 weeks
Heart rate
Time Frame: 8 weeks
8 weeks
Bone mineral density
Time Frame: 8 weeks
Measured using DXA
8 weeks
Bone mineral content
Time Frame: 8 weeks
Measured using DXA
8 weeks
Fat mass
Time Frame: 8 weeks
Measured using DXA
8 weeks
Blood C-reactive protein
Time Frame: 8 weeks
8 weeks
Blood interleukin 1 beta
Time Frame: 8 weeks
8 weeks
Blood tumor necrosis factor alpha
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Southern Queensland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Jones, PhD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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