Clinical trial NCT03948061: Cardiometabolic Effects of Sweet Cherry Juice
Official title: Cardiometabolic Effects of Sweet Cherry Juice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Keywords: cherries
inflammatory disease
chronic stress
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: Washington State Fruit Commission
First posted: 2019-05-13
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in systolic blood pressure
timeFrame: Week 0, 6 and 12
measure: Change in diastolic blood pressure
timeFrame: Week 0, 6 and 12
measure: Change in mean arterial blood pressure
timeFrame: Week 0, 6 and 12
measure: Change in heart rate variability
timeFrame: Week 0, 6 and 12
measure: Change in cardiac parasympathetic control
timeFrame: Week 0, 6 and 12
measure: Change in electrical activity of heartbeat
timeFrame: Week 0, 6 and 12
Secondary outcomes:
measure: Change in vascular function
timeFrame: Week 0, 6 and 12
measure: Change in liver stiffness
timeFrame: Week 0, 6 and 12
measure: Change in liver fat
timeFrame: Week 0, 6 and 12
measure: Change in executive function
timeFrame: Week 0, 6 and 12
measure: Change in attentive function
timeFrame: Week 0, 6 and 12
measure: Change in multitasking
timeFrame: Week 0, 6 and 12
measure: Change in psycho-motor speed
timeFrame: Week 0, 6 and 12
measure: Change in spatial memory
timeFrame: Week 0, 6 and 12
measure: Change in verbal memory
timeFrame: Week 0, 6 and 12
measure: Change in social cognition
timeFrame: Week 0, 6 and 12
measure: Change in peripheral insulin resistance (IR)
timeFrame: Week 0, 6 and 12
measure: Change in hepatic insulin resistance (IR)
timeFrame: Week 0, 6 and 12
measure: Change in salivary cortisol in response to glucose tolerance test
timeFrame: prior to and 120 minutes after glucose tolerance test
measure: Change in salivary cortisol in response to stress
timeFrame: prior to and 30, 60, 90 and 120 minutes after challenging task
measure: Change in body weight
timeFrame: Week 0, 6 and 12
measure: Change in waist circumference
timeFrame: Week 0, 6 and 12
measure: Change in activity level
timeFrame: Week 0, 6 and 12
measure: Change in mitochondrial respiration
timeFrame: Week 0, 6 and 12
measure: Change in cardiovascular related biomarkers
timeFrame: Week 0, 6 and 12
measure: Change in inflammation related biomarkers
timeFrame: Week 0, 6 and 12
measure: Change in neurological related biomarkers
timeFrame: Week 0, 6 and 12
measure: Change in perceived stress
timeFrame: Week 0, 6 and 12
measure: Change in chronic stress
timeFrame: Week 0, 6 and 12
measure: Change in self-reported sleep quality
timeFrame: Week 0, 6 and 12
measure: Change in mood
timeFrame: Week 0, 6 and 12
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA, ARS, Western Human Nutrition Research Center
state: California
Study officials:
References: