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

• Sponsor: University of Manitoba (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03594097
• Collaborator: University of Southern Queensland (Other), Advance Queensland (Other), Nutrafruit Pty Ltd (Other), Nature Pacific Pty Ltd (Other)
• Enrollment: 50
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 14.9
• Patients Per Site: 25
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Ageing	Other: Treatment cookies; Other: Control cookies	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Use of Coconut Nourish and Queen Garnet Plum to Improve Health in an Elderly Population
• Actual Study Start Date: Sep 4, 2018
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Lean mass [8 weeks]

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

Secondary Outcome Measures

1. Body weight [8 weeks]

2. Body mass index [8 weeks]

   Weight and height will be combined to report BMI in kg/m^2

3. Waist circumference [8 weeks]

4. Arm circumference [8 weeks]

5. Wrist circumference [8 weeks]

6. Calf circumference [8 weeks]

7. Triceps skinfold [8 weeks]

8. Five times chair standing test [8 weeks]

9. Handgrip dynamometer [8 weeks]

10. Blood pressure [8 weeks]

    Systolic and diastolic pressure will be assessed

11. Heart rate [8 weeks]

12. Bone mineral density [8 weeks]

    Measured using DXA

13. Bone mineral content [8 weeks]

    Measured using DXA

14. Fat mass [8 weeks]

    Measured using DXA

15. Blood total cholesterol [8 weeks]

16. Blood low-density lipoprotein cholesterol [8 weeks]

17. Blood high-density lipoprotein cholesterol [8 weeks]

18. Blood triglycerides [8 weeks]

19. Blood glucose [8 weeks]

20. Blood C-reactive protein [8 weeks]

21. Blood interleukin 1 beta [8 weeks]

22. Blood tumor necrosis factor alpha [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern Queensland	Toowoomba	Queensland	Australia	4350
2	Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba	Winnipeg	Manitoba	Canada	R3T 6C5

Sponsors and Collaborators

• University of Manitoba
• University of Southern Queensland
• Advance Queensland
• Nutrafruit Pty Ltd
• Nature Pacific Pty Ltd

Investigators

• Principal Investigator: Peter Jones, PhD, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Manitoba
• ClinicalTrials.gov Identifier: NCT03594097
• Other Study ID Numbers: HS21905 (B2018:052)
• First Posted: Jul 20, 2018
• Last Update Posted: Jan 15, 2019
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 15, 2019