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Dietary Supplement

70 mL red beetroot juice for Obesity

Phase 2
Waitlist Available
Research Sponsored by Colorado State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 1, 2 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Awards & highlights

Study Summary

Aside from aging, numerous factors increase the risk for developing cardiovascular disease (CVD) including diet and nutrition. High-fat meal consumption induces postprandial vascular endothelial dysfunction and other cardiometabolic disturbances (e.g. dyslipidemia and hyperglycemia) in normal weight individuals and is exacerbated in overweight/obese individuals. These postprandial responses are likely largely due to activation of pro-inflammatory and pro-oxidant pathways. Given that much of the day is spent in the postprandial state, this may further impair cardiovascular health in aging overweight/obese individuals. Interventions that attenuate these responses are needed. Red beetroot (Beta vulgaris L.) is an excellent source of bioactive compounds including nitrate, flavonoids, phenolic acids, betalains, carotenoids, and ascorbic acid. These bioactive compounds and their metabolites have been shown to have antioxidative, anti-inflammatory, and cardiovascular-protective effects. These effects, particularly the cardiovascular-protective effects, have been primarily attributed to its high content of nitrate since it is converted to nitric oxide independent of the vascular endothelium via the enterosalivary nitrate-nitrite-nitric oxide pathway. However, red beetroot juice contains a number of other potentially beneficial bioactive compounds and few studies have aimed to determine whether these compounds work independently, additively, or synergistically in exerting these effects. Given the findings of previously conducted research in the broad area of red beetroot juice consumption and human health, it can be suggested that: 1) acute red beetroot juice consumption may prevent or attenuate the adverse postprandial responses to consuming a high-fat meal in individuals with exaggerated responses; and 2) chronic consumption of red beetroot may improve underlying factors contributing to these exaggerated responses. Accordingly, this project aims to: 1) investigate the efficacy of acute and chronic whole red beetroot juice consumption compared with its bioactive components in attenuating postprandial vascular endothelial dysfunction and adverse cardiometabolic responses to a high-fat meal; and 2) to gain insight into the underlying mechanisms responsible.

Eligible Conditions
  • Obesity
  • Menopause
  • Aging

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 1, 2 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 1, 2 and 4 hours post-meal consumption at baseline and 1 month for each treatment period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vascular endothelial function
Secondary outcome measures
Arterial stiffness
Blood Glucose
Blood pressure
+5 more
Other outcome measures
Blood polyphenols and polyphenol metabolites
Oral and gut microbiome
Urinary polyphenols and polyphenol metabolites

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 70 mL red beetroot juiceExperimental Treatment1 Intervention
70 mL red beetroot juice naturally containing 300 mg nitrate.
Group II: 70 mL placebo drink plus potassium nitrateActive Control1 Intervention
70 mL calorie-matched placebo control drink containing 489 mg potassium nitrate to deliver 300 mg nitrate.
Group III: 70 mL red beetroot juice without nitrateActive Control1 Intervention
70 mL red beetroot juice per day without nitrate.
Group IV: 70 mL placebo drinkPlacebo Group1 Intervention
70 mL calorie-matched placebo control drink devoid of nitrate, vitamins, minerals, and polyphenols.

Find a Location

Who is running the clinical trial?

United States Department of Agriculture (USDA)FED
97 Previous Clinical Trials
350,747 Total Patients Enrolled
17 Trials studying Obesity
13,876 Patients Enrolled for Obesity
Colorado State UniversityLead Sponsor
125 Previous Clinical Trials
38,344 Total Patients Enrolled
14 Trials studying Obesity
7,226 Patients Enrolled for Obesity

Frequently Asked Questions

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~2 spots leftby Apr 2025