Cardiometabolic Effects of Sweet Cherry Juice

USDA, Western Human Nutrition Research Center

Status: Completed

Conditions: Obesity; Metabolic Syndrome

Treatments: Other: Cherry juice; Other: Placebo beverage

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT03948061

FL108

Details and patient eligibility

About

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.

Full description

The investigators will conduct a randomized, cross-over study lasting 14 weeks and including 1 week for screening/enrollment, 1 week baseline assessment, and two intervention periods of 6 weeks each for the cherry juice and placebo interventions. Two test visits, 3 to 7 days apart, will occur before the start of intervention (baseline, or week 0) and then at weeks 6 and 12. Participants will be randomized to consume either the cherry juice or placebo beverage first, and will cross over to the alternate intervention immediately following the end of the first 6 weeks. Test Visit 1 will include measures of blood pressure, vascular tone, liver fat and stiffness, post-prandial metabolic response to the study beverage, cardiovascular activity and function, and nervous system control of cardiovascular activity and tone. Acute effects of study beverages will be measured, as will the chronic effects of study beverage consumption after 6 weeks. At Test Visit 2, participants will take a standard 75 gram oral glucose tolerance test (OGTT). Participants will be equipped with physiological monitoring devices, which will monitor cardiovascular activity and function and nervous system control of cardiovascular activity and tone, and continuously measure blood pressure. A series of cognitive function tasks will be administered, and a mental stress test will be conducted. The Test Visit 1 and 2 will be repeated at week 6 and week 12 following each intervention with cherry juice or the placebo beverage.

Enrollment: 4 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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4 participants in 2 patient groups

Cherry juice followed by placebo

Experimental group

Description:

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

Treatment:

Other: Cherry juice

Other: Placebo beverage

Placebo beverage followed by cherry juice

Experimental group

Description:

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

Treatment:

Other: Cherry juice

Other: Placebo beverage