Cardiometabolic Effects of Sweet Cherry Juice

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    36
  • sponsor
    USDA, Western Human Nutrition Research Center
Updated on 13 March 2022
body mass index
systolic blood pressure
blood pressure diastolic
Accepts healthy volunteers

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.

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.

Details
Condition Obesity, Metabolic Syndrome
Treatment Placebo Beverage, Cherry juice
Clinical Study IdentifierNCT03948061
SponsorUSDA, Western Human Nutrition Research Center
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

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
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