- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06767176
Impact of Dietary Nitrate Supplementation on VO2max During Ramadan Fasting in Healthy Adults
The goal of this clinical trial is to determine if beetroot juice supplementation changes exercise performance following one week of Ramadan fasting in young, healthy adults. The main question it aims to answer is:
Does daily beetroot juice supplementation change VO2 max in fasting individuals during the first week of Ramadan?
Participants will:
Visit the lab before the start of Ramadan and after one week of fasting If assigned to intervention group, consume daily shots of beetroot juice (70ml) during the first week of Ramadan fasting Perform maximal exercise testing on a cycle ergometer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Recent literature demonstrates data showing a decrease in VO2max during the first week of Ramadan fasting. This is a practice observed by millions around the world every year, where individuals abstain from food and water from sunrise to sunset, dictated by the lunar calendar. Dietary nitrate consumption has been shown to increase VO2max and exercise performance. Therefore, the primary purpose of this study is to investigate whether dietary nitrate, in the form of beetroot juice, can help mitigate the decrease in VO2 max during the first week of Ramadan fasting.
24 young healthy adults will be recruited to undergo these two visits. The first visit will assess maximal oxygen uptake to determine aerobic fitness and metabolic exercise intensity zones under non-fasting conditions. The second visit will be completed after one week of Ramadan fasting. If assigned to the intervention group, participants will consume one shot (70ml) of Blonyx - Beet It Sport Nitrate 400 beetroot juice every day. Each shot contains 400mg of nitrates. Urine Specific Gravity will be measured after each visit to assess hydration status. The intervention group will also undergo Single Blood Draws after each visit to assess nitrate concentrations before and after a week of consumption.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Guelph, Canada
- University of Guelph
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Free of known cardiovascular or metabolic diseases or sleep disorders
- No history of smoking (within the past 3 months)
- Able to engage in physical activity assessed through the physical activity readiness questionnaire (PAR-Q+)
- No prescription of chronic medications other than oral contraceptives
- Able to abide by fasting protocols for all visits
- Individuals who are not allergic to ultrasound gel or beetroot juice
- Individuals who are not pregnant
Exclusion Criteria:
- Individuals diagnosed with cardiovascular or metabolic disease or sleep disorders
- Has a history of smoking (within the past 3 months)
- Not ready to engage in physical activity as assessed by the PAR-Q+
- Individuals prescribed chronic medications other than oral contraceptives
- Unable to abide by fasting protocols for any testing visit
- Allergic to ultrasound gel or beetroot juice
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: No Intervention
Normal Fasting, no intervention.
During this arm, participants will be asked to complete an exercise test before and after 1 week of Ramadan fasting.
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Experimental: Nitrate Supplementation
Participants will be asked to consume daily nitrate supplementation (70ml) in the form of beetroot juice for 7 days.
Participants will then complete a maximal exercise test as they fast.
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7 doses, taken daily, 70 ml shots, consumed in the morning before the start of fasting
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VO2 max
Time Frame: One--week differences between before and after 1 week of fasting, nitrate supplementation if in intervention group
|
Maximal Oxygen Uptakes will be assessed to analyze aerobic capacity and fitness under fasting conditions.
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One--week differences between before and after 1 week of fasting, nitrate supplementation if in intervention group
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nitrate Concentration levels
Time Frame: Comparison between blood before and after nitrate supplementation: one week
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Single blood draws will be taken after each visit for the nitrate supplementation group
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Comparison between blood before and after nitrate supplementation: one week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Phillip Millar, PhD, University of Guelph
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-01-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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