Beetroot Juice and Sleep

Mayo Clinic

Status: Enrolling

Conditions: Healthy

Treatments: Dietary Supplement: Placebo Beetroot Juice Supplement (pBRJ); Dietary Supplement: Active Beetroot Juice Supplement (aBRJ)

Study type: Interventional

Funder types: Other

Identifiers

NCT05864521

23-000874

Details and patient eligibility

About

The purpose of this study is to investigate the effects of acute inorganic nitrate supplementation (with beetroot) on the regulation of sleep and neurovascular physiology.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-35 or 65-80 years of age

Exclusion criteria

• Coronary artery disease
• Heart failure
• Pregnancy
• Diabetes
• Sleep disorders
• Shift workers
• Individuals who typically go to sleep after midnight
• Individuals who traveled across ≥2 time zones within one week of study visits
• Individuals with a history frequent kidney stones
• BMI ≥35.0kg/m2
• Use of nicotine-containing products within the two years preceding study visits
• Use of allopurinol, proton pump inhibitors, or other medications/supplements which interfere with the nitrate-nitrite-nitric oxide pathway or outcome measures

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Active Beetroot Juice Supplement (aBRJ) then Placebo Beetroot Juice Supplement (pBRJ)

Active Comparator group

Description:

Subjects randomized to this arm of the study will have aBRJ administered during Visit 2 and then pBRJ administered during Visit 3.

Treatment:

Dietary Supplement: Active Beetroot Juice Supplement (aBRJ)

Dietary Supplement: Placebo Beetroot Juice Supplement (pBRJ)

Placebo Beetroot Juice Supplement (pBRJ) then Active Beetroot Juice Supplement (aBRJ)

Active Comparator group

Description:

Subjects randomized to this arm of the study will have pBRJ administered during Visit 2 and then aBRJ administered during Visit 3.

Treatment:

Dietary Supplement: Active Beetroot Juice Supplement (aBRJ)

Dietary Supplement: Placebo Beetroot Juice Supplement (pBRJ)