Clinical trial NCT04177238: Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.
Official title: Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. Anthocyanins, found in high quantities in both tart cherries and blueberries are powerful antioxidants, that are potentially capable of improving cardiometabolic dysfunction. However, to date, no research has explored the cardiometabolic responses to tart cherry and blueberry supplementation.

Therefore, the primary purpose of the proposed investigation is to test the ability of oral tart cherry and blueberry supplementation to improve cardiometabolic parameters in healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Healthy
* 18 years of age and above
* Non-smoker
* BMI \< 30
* Able to give informed consent

Exclusion Criteria:

* Pregnancy
* Diabetes or any other metabolic/ uncontrolled hypertensive conditions
* Food allergies to cherries or blueberries
* Habitual consumption of blueberries/ cherries and/or blueberry/ cherry products
* Not regularly taking medication or antioxidant supplements

Primary outcomes:
measure: Blood pressure
timeFrame: Baseline
measure: % bodyfat
timeFrame: Baseline
measure: % bodyfat
timeFrame: 20 days
measure: Waist to hip ratio
timeFrame: Baseline
measure: Waist to hip ratio
timeFrame: 20 days
measure: Resting metabolic rate
timeFrame: Baseline
measure: Resting metabolic rate
timeFrame: 20 days
measure: Resting utilization of carbohydrates
timeFrame: Baseline
measure: Resting utilization of carbohydrates
timeFrame: 20 days
measure: Resting utilization of fats
timeFrame: Baseline
measure: Resting utilization of fats
timeFrame: 20 days
measure: Low-moderate intensity activity calories expended
timeFrame: Baseline
measure: Low-moderate intensity activity calories expended
timeFrame: 20 days
measure: Low-moderate intensity activity utilization of fats
timeFrame: Baseline
measure: Low-moderate intensity activity utilization of fats
timeFrame: 20 days
measure: Low-moderate intensity activity utilization of carbohydrates
timeFrame: Baseline
measure: Low-moderate intensity activity utilization of carbohydrates
timeFrame: 20 days
measure: Blood glucose
timeFrame: Baseline
measure: Blood glucose
timeFrame: 20 days
measure: Blood triglycerides
timeFrame: Baseline
measure: Blood triglycerides
timeFrame: 20 days
measure: Blood cholesterol (Total, HDL & LDL)
timeFrame: Baseline
measure: Blood cholesterol (Total, HDL & LDL)
timeFrame: 20 days
measure: Blood haemoglobin
timeFrame: Baseline
measure: Blood haemoglobin
timeFrame: 20 days
measure: Coop-Wonka chart
timeFrame: Baseline
measure: Coop-Wonka chart
timeFrame: 20 days
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: 20 days
measure: State Trait Anxiety Inventory
timeFrame: Baseline
measure: State Trait Anxiety Inventory
timeFrame: 20 days
measure: Insomnia Severity Index
timeFrame: Baseline
measure: Insomnia Severity Index
timeFrame: 20 days
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: 20 days
measure: Epworth Sleepiness Scale
timeFrame: Baseline
measure: Epworth Sleepiness Scale
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: University of Central Lancashire
state: Lancashire
Study officials:
References:
citation: Sinclair J, Shadwell G, Dillon S, Allan R, Butters B, Bottoms L. Effects of Montmorency Tart Cherry and Blueberry Juice on Cardiometabolic Outcomes in Healthy Individuals: Protocol for a 3-Arm Placebo Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Sep 16;18(18):9759. doi: 10.3390/ijerph18189759.