Your session is about to expire
← Back to Search
Vasodilator
Nitrate Supplementation for Metabolic Syndrome
Phase < 1
Waitlist Available
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 55-75
Individuals with a waist circumference >102 cm (40 in) for men and > 88 cm for women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 90 minutes following drinking the beetroot juice (single 140ml acute dose), 90 minutes following drinking the placebo drink (single 140ml acute dose), and after 4 weeks of daily (70ml) beetroot juice consumption
Awards & highlights
Study Summary
This trial tests if drinking beetroot juice can boost brain health in people with metabolic syndrome. #BeetrootJuice #BrainHealth
Who is the study for?
This trial is for adults aged 55-75 with metabolic syndrome, defined by having at least three of these: high triglycerides, low HDL cholesterol, large waist circumference, high blood pressure, or elevated fasting blood glucose. It's open to all genders and ethnicities but excludes smokers, those on nitrates or certain other medications like Viagra or anti-inflammatories, premenopausal women, individuals with active cancer or severe diseases.Check my eligibility
What is being tested?
The study tests if drinking beetroot juice can boost brain function and cognition in people with metabolic syndrome. Participants will be randomly given either real beetroot juice (active) or a placebo version without its active ingredients to compare effects.See study design
What are the potential side effects?
While the trial doesn't specify side effects of beetroot juice directly, common ones may include colored stool and urine due to the natural pigments in beets. Beetroot is generally considered safe; however individual reactions can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 55 and 75 years old.
Select...
My waist is over 40 inches (men) or 34.6 inches (women).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, 90 minutes following drinking the beetroot juice (single 140ml acute dose), 90 minutes following drinking the placebo drink (single 140ml acute dose), and after 4 weeks of daily (70ml) beetroot juice consumption
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 90 minutes following drinking the beetroot juice (single 140ml acute dose), 90 minutes following drinking the placebo drink (single 140ml acute dose), and after 4 weeks of daily (70ml) beetroot juice consumption
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Cerebral Autoregulation - NIRx (fNIRS/cerebral oxygenation) and finapres (blood pressure) derived waveforms for transfer function analysis
Changes in Neurovascular Coupling - changes in fNIRS signals during the N-back cognitive test
Cognitive Functioning - Change in N-back test performance
Secondary outcome measures
Changes in Pulse Wave Velocity - Colin Cardiovascular Profiling System 2000
Taste Profile of Juice (Sweetness, Bitterness, and Sourness) - Questionnaire developed in our lab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Metabolic Syndrome Older Adult - Placebo juice conditionExperimental Treatment1 Intervention
Participants with metabolic syndrome will be drinking nitrate rich beetroot juice from the James White Beet It company. Participants will drink one dose of 140mL beetroot juice for two visits of either a nitrate rich juice or a nitrate depleted placebo drink. Both drinks taste and smell the same, just with the active component removed. Following these visits, participants will drink 70ml of nitrate rich beetroot juice daily for 4 weeks to investigate long term effects of the juice on study outcomes.
Group II: Metabolic Syndrome Older AdultExperimental Treatment1 Intervention
Participants with metabolic syndrome will be drinking nitrate rich beetroot juice from the James White Beet It company. Participants will drink one dose of 140mL beetroot juice for two visits of either a nitrate rich juice or a nitrate depleted placebo drink. Both drinks taste and smell the same, just with the active component removed. Following these visits, participants will drink 70ml of nitrate rich beetroot juice daily for 4 weeks to investigate long term effects of the juice on study outcomes.
Find a Location
Who is running the clinical trial?
Penn State UniversityLead Sponsor
355 Previous Clinical Trials
125,735 Total Patients Enrolled
8 Trials studying Metabolic Syndrome
555 Patients Enrolled for Metabolic Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 55 and 75 years old.Your "good" cholesterol (HDL) levels are too low.I have difficulty seeing.This criterion does not exclude anyone based on their race or ethnicity.I am either a man or a woman.My cancer is currently active.My depression score indicates moderate to severe depression.Your triglyceride levels are higher than 150 mg/dL.You have difficulties with memory or thinking, as shown by a test called the MMSE where you scored less than 24.Your blood sugar level is higher than 100 mg/dL after not eating for a while.I do not have any major heart, blood, lung, kidney, muscle, or nerve diseases.You use any form of tobacco or nicotine products, including smoking, chewing tobacco, nicotine patches/gum, or e-cigarettes.I am premenopausal, as indicated by my recent menstrual cycle.I am currently taking anti-inflammatory medication.You are only eligible if you have at least 3 out of the 5 specific health conditions that make up MetS according to the NCEP III definition.I am taking medication for chest pain.I am currently taking medication like Viagra.My waist is over 40 inches (men) or 34.6 inches (women).Your blood pressure is higher than 130/85 mmHg.I am currently on hormone replacement therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Metabolic Syndrome Older Adult - Placebo juice condition
- Group 2: Metabolic Syndrome Older Adult
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research include individuals in excess of 35 years old?
"This medical trial has specified that the minimum age of admission is 55 and the maximum age of participation is 75, in accordance with its eligibility criteria."
Answered by AI
Who would be qualified to participate in this medical research?
"Eligibility for this trial entails having metabolic syndrome and being between the ages of 55 to 75. The recruitment target is 25 patients in total."
Answered by AI
Are there any available slots for participants in this research endeavor?
"Indications from clinicaltrials.gov point to this study actively recruiting people for participation - the original post being on December 1st 2022 and last updated January 13th 2023."
Answered by AI
How many participants has this trial recruited thus far?
"Affirmative. The information accessible on clinicaltrials.gov corroborates that this trial is actively enrolling participants as of January 13th, 2023; it was initially posted more than a month prior, on December 1st 2022 and seeks 25 volunteers from one centre."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger