NCT03594097

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 Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

March 20, 2023

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

July 10, 2018

Last Update Submit

March 16, 2023

Conditions

Healthy Ageing

Outcome Measures

Primary Outcomes (1)

  • Lean mass

    Measured using dual-energy x-ray absorptiometry (DXA)

    8 weeks

Secondary Outcomes (22)

  • Body weight

    8 weeks

  • Body mass index

    8 weeks

  • Waist circumference

    8 weeks

  • Arm circumference

    8 weeks

  • Wrist circumference

    8 weeks

  • +17 more secondary outcomes

Study Arms (2)

Treatment cookies

EXPERIMENTAL
Other: Treatment cookies

Control cookies

ACTIVE COMPARATOR
Other: Control cookies

Interventions

Treatment cookiesOTHER

Plain flour, Coconut Nourish, Queen Garnet Plum, Unsalted Butter, Artificial Sweetener

Treatment cookies
Control cookiesOTHER

Plain flour, Coconut Powder, Unsalted Butter, Artificial Sweetener, Food Colour

Control cookies

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Southern Queensland

Toowoomba, Queensland, 4350, Australia

Location

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, R3T 6C5, Canada

Location

Study Officials

  • Peter Jones, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2018

First Posted

July 20, 2018

Study Start

September 4, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

March 20, 2023

Record last verified: 2021-04

Locations

AU(1)CA(1)