Effects of Red Beetroot Juice on High-Fat Meal-Induced Endothelial Dysfunction and Cardiometabolic Disturbances

NCT02949115 | Unknown Phase 2

• 1 other identifier: COL00729
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Obesity; Aging; Menopause

Keywords

Red beetroot; Dietary Nitrate; Polyphenols; Endothelial Function; High-Fat Meal; Overweight; Obesity; Aging; Cardiometabolic

Outcome Measures

Primary Outcomes (1)

• Vascular endothelial function

  Vascular endothelial function will be assessed using reactive hyperemia index (EndoPAT) 0 and 4 hours post-meal consumption.

  0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.

Secondary Outcomes (8)

• Blood glucose, insulin, and indices of insulin sensitivity and resistance

  0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.

• Blood triglycerides

  0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.

• Blood pressure

  0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period

• Heart rate

  0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.

• Arterial stiffness

  Pre-meal consumption at baseline and 1 month for each treatment period.

Other Outcomes (3)

• Blood polyphenols and polyphenol metabolites

  0, 1, 2 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.

• Urinary polyphenols and polyphenol metabolites

  0 and 24 hours post-meal consumption at baseline and 1 month for each treatment period.

• Oral and gut microbiome

  Pre-meal consumption at baseline and 1 month for each treatment period.

Study Arms (4)

70 mL red beetroot juice

EXPERIMENTAL

70 mL red beetroot juice naturally containing 300 mg nitrate.

Dietary Supplement: 70 mL red beetroot juice

70 mL placebo drink plus potassium nitrate

ACTIVE COMPARATOR

70 mL calorie-matched placebo control drink containing 489 mg potassium nitrate to deliver 300 mg nitrate.

Dietary Supplement: 70 mL placebo drink plus potassium nitrate

70 mL red beetroot juice without nitrate

ACTIVE COMPARATOR

70 mL red beetroot juice per day without nitrate.

Dietary Supplement: 70 mL red beetroot juice without nitrate

70 mL placebo drink

PLACEBO COMPARATOR

70 mL calorie-matched placebo control drink devoid of nitrate, vitamins, minerals, and polyphenols.

Dietary Supplement: 70 mL placebo drink

Interventions

70 mL red beetroot juice DIETARY_SUPPLEMENT

1x daily intake of 70 mL red beetroot juice

70 mL red beetroot juice

70 mL red beetroot juice without nitrate DIETARY_SUPPLEMENT

1x daily intake of 70 mL red beetroot juice without nitrate

70 mL red beetroot juice without nitrate

70 mL placebo drink plus potassium nitrate DIETARY_SUPPLEMENT

1x daily intake of 70 mL placebo control drink plus 489 mg potassium nitrate (300 mg nitrate)

70 mL placebo drink plus potassium nitrate

70 mL placebo drink DIETARY_SUPPLEMENT

1x daily intake of 70 mL placebo control drink

70 mL placebo drink

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women and men
• BMI between 25 and 40 kg/m2

You may not qualify if:

• Hypertension, cardiovascular disease, diabetes, cancer, or kidney, liver, or pancreatic disease
• Individuals taking gastroesophageal reflux, antihypertensive, hypoglycemic, lipid-lowering, hormone replacement, erectile dysfunction medications or nitrates
• Participating in a weight loss program or actively trying to lose weight
• Smokers
• Heavy drinkers (\> 3 drinks on any given occasion and/or \> 7 drinks/week for women, or \> 4 drinks on any given occasion and/or \> 14 drinks/week for men)
• Allergy to meals/treatments
• Consuming \> 2 servings red beetroot or beetroot juice/wk

Sponsors & Collaborators

• Colorado State University: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Department of Food Science and Human Nutrition, Colorado State University

Fort Collins, Colorado, 80523-1571, United States

Location

Related Publications (1)

• Litwin NS, Van Ark HJ, Hartley SC, Michell KA, Vazquez AR, Fischer EK, Melby CL, Weir TL, Wei Y, Rao S, Hildreth KL, Seals DR, Pagliassotti MJ, Johnson SA. Impact of Red Beetroot Juice on Vascular Endothelial Function and Cardiometabolic Responses to a High-Fat Meal in Middle-Aged/Older Adults with Overweight and Obesity: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. Curr Dev Nutr. 2019 Oct 17;3(11):nzz113. doi: 10.1093/cdn/nzz113. eCollection 2019 Nov.

  PMID: 31737860 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Nitrates; potassium nitrate

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: October 31, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: June 1, 2019
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)