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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03594097




Registration number
NCT03594097
Ethics application status
Date submitted
10/07/2018
Date registered
20/07/2018
Date last updated
15/01/2019

Titles & IDs
Public title
Use of Coconut Nourish and Queen Garnet Plum to Improve Health in an Elderly Population
Scientific title
Use of Coconut Nourish and Queen Garnet Plum to Improve Health in an Elderly Population
Secondary ID [1] 0 0
HS21905 (B2018:052)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Ageing 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Treatment cookies
Other interventions - Control cookies

Experimental: Treatment cookies -

Active Comparator: Control cookies -


Other interventions: Treatment cookies
Plain flour, Coconut Nourish, Queen Garnet Plum, Unsalted Butter, Artificial Sweetener

Other interventions: Control cookies
Plain flour, Coconut Powder, Unsalted Butter, Artificial Sweetener, Food Colour

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lean mass - Measured using dual-energy x-ray absorptiometry (DXA)
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Body weight
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Body mass index - Weight and height will be combined to report BMI in kg/m^2
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Waist circumference
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Arm circumference
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Wrist circumference
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
Calf circumference
Timepoint [6] 0 0
8 weeks
Secondary outcome [7] 0 0
Triceps skinfold
Timepoint [7] 0 0
8 weeks
Secondary outcome [8] 0 0
Five times chair standing test
Timepoint [8] 0 0
8 weeks
Secondary outcome [9] 0 0
Handgrip dynamometer
Timepoint [9] 0 0
8 weeks
Secondary outcome [10] 0 0
Blood pressure - Systolic and diastolic pressure will be assessed
Timepoint [10] 0 0
8 weeks
Secondary outcome [11] 0 0
Heart rate
Timepoint [11] 0 0
8 weeks
Secondary outcome [12] 0 0
Bone mineral density - Measured using DXA
Timepoint [12] 0 0
8 weeks
Secondary outcome [13] 0 0
Bone mineral content - Measured using DXA
Timepoint [13] 0 0
8 weeks
Secondary outcome [14] 0 0
Fat mass - Measured using DXA
Timepoint [14] 0 0
8 weeks
Secondary outcome [15] 0 0
Blood total cholesterol
Timepoint [15] 0 0
8 weeks
Secondary outcome [16] 0 0
Blood low-density lipoprotein cholesterol
Timepoint [16] 0 0
8 weeks
Secondary outcome [17] 0 0
Blood high-density lipoprotein cholesterol
Timepoint [17] 0 0
8 weeks
Secondary outcome [18] 0 0
Blood triglycerides
Timepoint [18] 0 0
8 weeks
Secondary outcome [19] 0 0
Blood glucose
Timepoint [19] 0 0
8 weeks
Secondary outcome [20] 0 0
Blood C-reactive protein
Timepoint [20] 0 0
8 weeks
Secondary outcome [21] 0 0
Blood interleukin 1 beta
Timepoint [21] 0 0
8 weeks
Secondary outcome [22] 0 0
Blood tumor necrosis factor alpha
Timepoint [22] 0 0
8 weeks

Eligibility
Key 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.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of Southern Queensland - Toowoomba
Recruitment postcode(s) [1] 0 0
4350 - Toowoomba
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Manitoba

Funding & Sponsors
Primary sponsor type
Other
Name
University of Manitoba
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Southern Queensland
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Advance Queensland
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Nutrafruit Pty Ltd
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Nature Pacific Pty Ltd
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03594097
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Jones, PhD
Address 0 0
University of Manitoba
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stephanie Jew, BSc
Address 0 0
Country 0 0
Phone 0 0
204-272-1549
Fax 0 0
Email 0 0
stephanie.jew@umanitoba.ca
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03594097