Cardiometabolic Effects of Sweet Cherry Juice

NCT03948061 | Completed

• 1 other identifier: FL108
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the effects of consuming sweet cherry juice on cardiovascular function, glucose regulation, and lipid status in overweight human subjects. The investigators hypothesize that sweet cherry juice consumption will improve metabolic and physiological status in overweight persons compared to a placebo.

Conditions

Obesity; Metabolic Syndrome

Keywords

cherries; inflammatory disease; chronic stress

Outcome Measures

Primary Outcomes (6)

• Change in systolic blood pressure

  Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg

  Week 0, 6 and 12

• Change in diastolic blood pressure

  Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg

  Week 0, 6 and 12

• Change in mean arterial blood pressure

  Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg

  Week 0, 6 and 12

• Change in heart rate variability

  Heart rate variability (HRV) assessed using a mobile device via ECG in millivolts

  Week 0, 6 and 12

• Change in cardiac parasympathetic control

  Assessed using impedance cardiography (ICG) and ECG

  Week 0, 6 and 12

• Change in electrical activity of heartbeat

  Assessed using electrocardiogram (ECG)

  Week 0, 6 and 12

Secondary Outcomes (25)

• Change in vascular function

  Week 0, 6 and 12

• Change in liver stiffness

  Week 0, 6 and 12

• Change in liver fat

  Week 0, 6 and 12

• Change in executive function

  Week 0, 6 and 12

• Change in attentive function

  Week 0, 6 and 12

Study Arms (2)

Cherry juice followed by placebo

EXPERIMENTAL

Sweet cherry juice concentrate will be consumed twice daily for 6 weeks, followed by consumption of placebo beverage twice daily for 6 weeks.

Other: Cherry juice; Other: Placebo beverage

Placebo beverage followed by cherry juice

EXPERIMENTAL

Placebo beverage will be consumed twice daily for 6 weeks, followed by consumption of sweet cherry juice concentrate twice daily for 6 weeks.

Other: Cherry juice; Other: Placebo beverage

Interventions

Cherry juice OTHER

FruitSmart® Cherry Concentrate: Dark Sweet Cherry Juice Concentrate produced from dark sweet cherries to retain the characteristic color and flavor of the whole fruit.

Cherry juice followed by placebo; Placebo beverage followed by cherry juice

Placebo beverage OTHER

Cherry flavored placebo beverage prepared from commercially available cherry syrup with food coloring and thickener to match the color and viscosity of the cherry concentrate.

Cherry juice followed by placebo; Placebo beverage followed by cherry juice

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 20 - 65 years
• Post-menopausal women aged 45 - 65 years
• Body Mass Index ≥25 and \<40 kg/m2
• Systolic blood pressure \>120 and \<140 mmHg or diastolic blood pressure \>80 and \<90 mmHg

You may not qualify if:

• Diagnosed metabolic disorder
• Diabetes mellitus
• Thyroid disease
• Cardiovascular disease
• Poly-cystic ovary syndrome
• Vasoconstrictive diseases (e.g. Raynaud's phenomenon or Raynaud's disease)
• Digestive disorder (e.g. Crohn's, irritable bowel syndrome, colitis)
• History of gastrointestinal surgery affecting digestion and/or absorption
• Use of medications for hypertension, hyperlipidemia, glycemic control, or weight loss
• Use of medications such as steroids, statins, or non-steroidal anti-inflammatory agents
• Routine use of over-the-counter medications
• Weight change \>5% in the past 6 months
• Performing exercise greater than 60 minutes/day
• Presence of a pacemaker or other internal electronic device controlling rhythm or pacing of heart excludes participant from MindWare procedure
• Presence of atrial fibrillation or other arrhythmia excludes participant from MindWare procedure

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead
• Washington State Fruit Commission: collaborator

Study Sites (1)

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 13, 2019
• Study Start: October 1, 2019
• Primary Completion: October 25, 2023
• Study Completion: October 25, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)