Healthy AgeingNCT03594097
Use of Coconut Nourish and Queen Garnet Plum to Improve Health in an Elderly Population
A study testing Treatment cookies in people with Healthy Ageing, run by University of Manitoba at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Ageing
- What is being tested?
- Treatment cookies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Sep 2018to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
University of Southern Queensland
Toowoomba, Queensland, 4350
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, R3T 6C5
About this study
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.
- Conditions
- Healthy Ageing
- Being tested
- Treatment cookies, Control cookies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment cookiesOther
Plain flour, Coconut Nourish, Queen Garnet Plum, Unsalted Butter, Artificial Sweetener
Control cookiesOther
Plain flour, Coconut Powder, Unsalted Butter, Artificial Sweetener, Food Colour
| Study group | Role | What they receive |
|---|---|---|
| Treatment cookies | Experimental | Not described Receives: Other: Treatment cookies |
| Control cookies | Active comparator | Not described Receives: Other: Control cookies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean mass
Measured using dual-energy x-ray absorptiometry (DXA)
Measured: 8 weeks
Secondary outcomes (22)
Body weight
Measured: 8 weeks
Body mass index
Weight and height will be combined to report BMI in kg/m^2
Measured: 8 weeks
Waist circumference
Measured: 8 weeks
Arm circumference
Measured: 8 weeks
Wrist circumference
Measured: 8 weeks
Calf circumference
Measured: 8 weeks
Triceps skinfold
Measured: 8 weeks
Five times chair standing test
Measured: 8 weeks
Handgrip dynamometer
Measured: 8 weeks
Blood pressure
Systolic and diastolic pressure will be assessed
Measured: 8 weeks
Heart rate
Measured: 8 weeks
Bone mineral density
Measured using DXA
Measured: 8 weeks
Bone mineral content
Measured using DXA
Measured: 8 weeks
Fat mass
Measured using DXA
Measured: 8 weeks
Blood total cholesterol
Measured: 8 weeks
Blood low-density lipoprotein cholesterol
Measured: 8 weeks
Blood high-density lipoprotein cholesterol
Measured: 8 weeks
Blood triglycerides
Measured: 8 weeks
Blood glucose
Measured: 8 weeks
Blood C-reactive protein
Measured: 8 weeks
Blood interleukin 1 beta
Measured: 8 weeks
Blood tumor necrosis factor alpha
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start4 Sep 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Why it stopped: Due to the study sponsor's request to prematurely terminate this study, the numbers of participants enrolled in the study discontinued or some discontinued earlier due to a screening failure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgeingStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Queensland
- Responsible party
- Sponsor
- Investigators
- Peter Jones, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594097
- Sponsor's protocol ID
- HS21905 (B2018:052)
- Status last verified
- Apr 2021
- First submitted
- 10 Jul 2018
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Coconut Nourish and Queen Garnet Plum to Improve Health in an Elderly Population
- ClinicalTrials.gov ID
- NCT03594097
- Acronym / sponsor ID
- HS21905 (B2018:052)
- Conditions
- Healthy Ageing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the study sponsor's request to prematurely terminate this study, the numbers of participants enrolled in the study discontinued or some discontinued earlier due to a screening failure.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of Southern Queensland
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment cookies | Experimental | Other: Treatment cookies |
| Control cookies | Active comparator | Other: Control cookies |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment cookiesPlain flour, Coconut Nourish, Queen Garnet Plum, Unsalted Butter, Artificial Sweetener | Other | Treatment cookies |
| Control cookiesPlain flour, Coconut Powder, Unsalted Butter, Artificial Sweetener, Food Colour | Other | Control cookies |
Primary outcome
Lean mass
Time frame: 8 weeks
Measured using dual-energy x-ray absorptiometry (DXA)
22 secondary outcomes
Body weight
Time frame: 8 weeks
Body mass index
Time frame: 8 weeks
Waist circumference
Time frame: 8 weeks
Arm circumference
Time frame: 8 weeks
Wrist circumference
Time frame: 8 weeks
Calf circumference
Time frame: 8 weeks
Triceps skinfold
Time frame: 8 weeks
Five times chair standing test
Time frame: 8 weeks
Handgrip dynamometer
Time frame: 8 weeks
Blood pressure
Time frame: 8 weeks
Heart rate
Time frame: 8 weeks
Bone mineral density
Time frame: 8 weeks
Bone mineral content
Time frame: 8 weeks
Fat mass
Time frame: 8 weeks
Blood total cholesterol
Time frame: 8 weeks
Blood low-density lipoprotein cholesterol
Time frame: 8 weeks
Blood high-density lipoprotein cholesterol
Time frame: 8 weeks
Blood triglycerides
Time frame: 8 weeks
Blood glucose
Time frame: 8 weeks
Blood C-reactive protein
Time frame: 8 weeks
Blood interleukin 1 beta
Time frame: 8 weeks
Blood tumor necrosis factor alpha
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Due to the study sponsor's request to prematurely terminate this study, the numbers of participants enrolled in the study discontinued or some discontinued earlier due to a screening failure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Jones, PhD principal investigator
University of Manitoba
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment cookies in people with Healthy Ageing, run by University of Manitoba at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the study sponsor's request to prematurely terminate this study, the numbers of participants enrolled in the study discontinued or some discontinued earlier due to a screening failure.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean mass (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.