Heat Acclimation and ThermotoleranceNCT01168739
Effect of Combined Exercise, Heat, and Quercetin Supplementation on Whole Body Stress Response
A study testing Quercetin in people with Heat Acclimation and Thermotolerance, run by University of New Mexico at 1 site in United States.
Trial summary
The purpose of this study is to determine whether dietary quercetin supplementation effects thermotolerance and heat acclimation in human subjects exposed to exercise/heat stress. Specific Aim I. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heat Acclimation and Thermotolerance
- What is being tested?
- Quercetin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy: 1 or less CV risk factor. Positive risk factors include:
- Family history
- Current cigarette smoker or quit within the previous 6 months
- Hypertension (>140/90 mmHg) or on antihypertensive medication
- Impaired fasting glucose (>110 mg/dl)
- Dyslipidemia (LDL>130 mg/dl;HDL<40 mg/dl, total >200 mg/dl)
Show all 14Show fewer
- Low VO2 peak: <40ml/kg/min
- Overfatness(BMI>30 kg/m2 and/or body fat > 25%)
- Male
- 18-39 years of age
- Willing to follow study diet
- Willing to exercise for prescribed time
- Willing to tolerate hot environment
- Willing to avoid external influences (ambient heat, uv exposure, external exercise) for study duration
Who cannot join
- History of heat illness
- Current NSAID use
- Known gastrointestinal disease
- Illness (physician provide physical before subject begin each condition)
Trial locations and contacts
1 site in 1 country.
United States1 site
UNM General Clinical Research Center
Albuquerque, New Mexico, 87131
About this study
The purpose of this study is to determine whether dietary quercetin supplementation effects thermotolerance and heat acclimation in human subjects exposed to exercise/heat stress.
Specific Aim I. To determine if quercetin in combination with repeated bouts of thermally stressful exercise will impact intestinal barrier function. The investigators will examine urinary lactulose excretion, plasma endotoxin,plasma quercetin, inflammatory cytokines (TNF-a \& Il-6), anti-inflammatory cytokines (Il-10), and HSP70 and HSF-1 content of peripheral blood mononuclear cells.
Specific Aim II. To determine whether quercetin's suppresses the ability of human subjects to acclimate to exercise/heat stress. The investigators will examine body temperatures, heart rates, physiological strain, sweat and plasma volume responses to standardized heat tolerance tests.
Read the detailed description
Overall Protocol:
This study will involve a repeated-measures design (2 conditions) in which subjects will perform exercise in the heat. Each condition will begin with an Intestinal Permeability Measurement (IP1), where subjects will be admitted to the General Clinical Research Center (GCRC), drinking a test solution and collecting their urine for 8 hours to measure intestinal integrity prior to heat stress. This will be followed by a Heat Tolerance Trial (HT1: 50min exercise at 50% VO2max in environmental chamber controlled at 56oC, 20%RF), used as a baseline measurement of subject's capacity to work in the heat. Following HT1 each subject will perform 7 Days of Heat Acclimation (HA)exercise (controlled hyperthermia design, each subject will elevate core temperature >39oC in 50min during 50 minutes of exercise in environmental chamber controlled at 56oC, 20%RF; rest 10 min in environmental chamber; then perform another 50min of exercise at this elevated core temperature). On days 1 and 7 of HA subjects will follow exercise by performing additional Intestinal Permeability Measurements, providing pre (IP2) and post acclimation (IP3) measurements of intestinal permeability. Day 6 of HA will provide a posttest measurement of subjects' capacity to work in the heat, and will be synonymous with Heat Tolerance Trial 2 (HT2).
Subjects will take quercetin during the seven days of HA in one condition, and placebo in the other. At least 1 month must elapse before a subject will be allowed to repeat the opposite condition. The order will be balanced (half will take quercetin first, the other half placebo). This will be a double blinded study. Neither the investigators nor the subjects will know whether a HA involves quercetin or placebo.
Due to the possibility of outside factors causing variations in intestinal permeability over the course of the study, IP1 will always be used as a baseline condition, with IP2 and IP3 being scored relative (as percent change) to the first. Subjects will never be supplemented in IP1, as this might affect basal measurements of permeability. However, because quercetin supplementation may only exert a transient effect on intestinal permeability, subjects will always be supplemented (with either placebo or quercetin, according to condition) in IP2 and IP3.
In all conditions, subjects will be required to follow guidelines on diet and exercise. They will be instructed to avoid caffeine, alcohol, and to stay well hydrated. They will be instructed to avoid exercise that is not directly outlined by the experiment (see attached). Their meals will be provided by the GCRC to ensure adequate nutrition and to avoid high dietary levels of quercetin. We are currently working with BioNutrition on this menu. To ensure compliance with this diet, subjects will fill out a food diary.
- Conditions
- Heat Acclimation and Thermotolerance
- Being tested
- Quercetin, Placebo
- Keywords
- thermotolerance, heat acclimation, quercetin, exertional heat illness, gastrointestinal barrier permeability
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuercetinDietary supplement
2g/d dietary quercetin supplementation, 1g taken am; 1g taken pm
PlaceboDietary supplement
Placebo, performed on same subjects as Quercetin Arm, used to compare results between conditions
| Study group | Role | What they receive |
|---|---|---|
| Quercetin | Experimental | not necessary, contained in protocol Receives: Dietary Supplement: Quercetin |
| Placebo | Placebo comparator | not necessary, contained in protocol Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Lactulose Excretion
Lactulose is a large molecule (disaccharide: 242 kDa) that should not be permeable to the gastrointestinal barrier under normal conditions.
Subjects will ingest a test solution containing 10 g lactulose (Quintron Instrument Company, QT02500-10-5, Milwaukee, WI, USA) dissolved in 50 ml of distilled water. This is followed by 8 hour urine collection.
Measured: Baseline
Plasma endotoxin
Plasma endotoxin will be detected with a standard limulus amebocyte lysate (LAL) kit (Cell Sciences, HIT302, Canton, MA, USA). The minimum and maximum detection limits of this kit are 1.4 pg/ml and 1,000 pg/ml, respectively.
Measured: Baseline
Plasma Quercetin
Quercetin conjugates are hydrolysized from plasma with B-glucuronidase and arylsulfatase kit (Roche Diagnostics, 10127698001, Indianapolis, IN, USA). The resulting supernatant is applied to solid phase extraction cartridges and run through a vacuum manifold for purification. The eluent is 80% methanol / 20% 18 MOhm water. Following solid phase extraction chromatographic analysis is performed using high performance liquid chromatography (HPLC).
Measured: Baseline
Plasma TNF-a
Measured: pre, post, 2hours post, 4 hours post exercise on Day 1 of exercise/heat stress
plasma Il-6
Measured: Pre, post, 2hours post, 4 hours post exercise, day 1 of exercise/heat stress
Plasma Il-10
Measured: Pre, post, 2 hours post, 4 hours post exercise on Day 1 of exercise/heat stress
HSP70 content of peripheral blood mononuclear cells
Measured: Pre, post, 2 hours post, 4 hours post exercise on day 1 of exercise/heat stress
HSF-1 content of peripheral blood mononuclear cells
Measured: Pre, post, 2 hours post, 4 hours post exercise on day 1 of exercise/heat stress
Core temperature response to heat tolerance test
Measured: heat tolerance test 1= before study onset
Skin temperature response to heat tolerance test
Measured: heat tolerance test 1= before study onset
Mean body temperature response to heat tolerance test
Measured: heat tolerance test 1= before study onset
Heart rate response to heat tolerance test
Measured: heat tolerance test 1= before study onset
Physiological strain response to heat tolerance test
Measured: heat tolerance test 1= before study onset
Urinary Lactulose Excretion
Measured: Day 1 of exercise/heat stress
Urinary Lactulose Excretion
Measured: Day 7 of exercise/heat stress
Plasma Quercetin
Measured: Day 1 of exercise/heat stress
Plasma Quercetin
Measured: Day 7 of exercise/heat stress
Plasma Endotoxin
Measured: Day 1 of exercise/heat stress
plasma endotoxin
Measured: day 7 of exercise/heat stress
Plasma TNF-a
Measured: pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress
plasma Il-10
Measured: pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress
plasma Il-6
Measured: pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress
HSP70 content of peripheral blood mononuclear cells
Measured: pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress
HSF-1 content of peripheral blood mononuclear cells
Measured: pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress
Core temperature response to heat tolerance test
Measured: heat tolerance trial 2 = day 6 of exercise/heat stress
Skin temperature response to heat tolerance test
Measured: heat tolerance trial 2 = day 6 of exercise/heat stress
Mean body temperature response to heat tolerance test
Measured: heat tolerance trial 2 = day 6 of exercise/heat stress
Heart rate response to heat tolerance test
Measured: heat tolerance trial 2 = day 6 of exercise/heat stress
physiological strain response to heat tolerance test
Measured: heat tolerance trial 2 = day 6 of exercise/heat stress
Secondary outcomes (4)
Improvements in sweat rate following heat acclimation exercise
Measured: heat tolerance test 1= before study onset
Plasma volume expansion in response to heat acclimation exercise
Measured: heat tolerance test 1= before study onset
Improvements in sweat rate following heat acclimation exercise
Measured: heat tolerance trial 2 = day 6 of exercise/heat stress
plasma volume expansion in response to heat acclimation exercise
Measured: heat tolerance trial 2 = day 6 of exercise/heat stress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat Acclimation and ThermotoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Gatorade Sports and Science Institute, Quercegen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Pope L Moseley, MD, Principal investigator, University of New Mexico, Professor and Chariman, Dpt of Internal MedicineMatthew R. Kuennen, PhD, Study director, UNM Department of Health, Exercise and Sports Sciences and UNM Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168739
- Sponsor's protocol ID
- HRRC08-606
- Status last verified
- Mar 2024
- First submitted
- 20 Jul 2010
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Exercise, Heat, and Quercetin Supplementation on Whole Body Stress Response
- ClinicalTrials.gov ID
- NCT01168739
- Acronym / sponsor ID
- HRRC08-606
- Conditions
- Heat Acclimation and Thermotolerance
- Keywords
- thermotolerance, heat acclimation, quercetin, exertional heat illness, gastrointestinal barrier permeability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Gatorade Sports and Science Institute, Quercegen Pharmaceuticals
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether dietary quercetin supplementation effects thermotolerance and heat acclimation in human subjects exposed to exercise/heat stress.
Specific Aim I. To determine if quercetin in combination with repeated bouts of thermally stressful exercise will impact intestinal barrier function. The investigators will examine urinary lactulose excretion, plasma endotoxin,plasma quercetin, inflammatory cytokines (TNF-a \& Il-6), anti-inflammatory cytokines (Il-10), and HSP70 and HSF-1 content of peripheral blood mononuclear cells.
Specific Aim II. To determine whether quercetin's suppresses the ability of human subjects to acclimate to exercise/heat stress. The investigators will examine body temperatures, heart rates, physiological strain, sweat and plasma volume responses to standardized heat tolerance tests.
Detailed description
Overall Protocol:
This study will involve a repeated-measures design (2 conditions) in which subjects will perform exercise in the heat. Each condition will begin with an Intestinal Permeability Measurement (IP1), where subjects will be admitted to the General Clinical Research Center (GCRC), drinking a test solution and collecting their urine for 8 hours to measure intestinal integrity prior to heat stress. This will be followed by a Heat Tolerance Trial (HT1: 50min exercise at 50% VO2max in environmental chamber controlled at 56oC, 20%RF), used as a baseline measurement of subject's capacity to work in the heat. Following HT1 each subject will perform 7 Days of Heat Acclimation (HA)exercise (controlled hyperthermia design, each subject will elevate core temperature >39oC in 50min during 50 minutes of exercise in environmental chamber controlled at 56oC, 20%RF; rest 10 min in environmental chamber; then perform another 50min of exercise at this elevated core temperature). On days 1 and 7 of HA subjects will follow exercise by performing additional Intestinal Permeability Measurements, providing pre (IP2) and post acclimation (IP3) measurements of intestinal permeability. Day 6 of HA will provide a posttest measurement of subjects' capacity to work in the heat, and will be synonymous with Heat Tolerance Trial 2 (HT2).
Subjects will take quercetin during the seven days of HA in one condition, and placebo in the other. At least 1 month must elapse before a subject will be allowed to repeat the opposite condition. The order will be balanced (half will take quercetin first, the other half placebo). This will be a double blinded study. Neither the investigators nor the subjects will know whether a HA involves quercetin or placebo.
Due to the possibility of outside factors causing variations in intestinal permeability over the course of the study, IP1 will always be used as a baseline condition, with IP2 and IP3 being scored relative (as percent change) to the first. Subjects will never be supplemented in IP1, as this might affect basal measurements of permeability. However, because quercetin supplementation may only exert a transient effect on intestinal permeability, subjects will always be supplemented (with either placebo or quercetin, according to condition) in IP2 and IP3.
In all conditions, subjects will be required to follow guidelines on diet and exercise. They will be instructed to avoid caffeine, alcohol, and to stay well hydrated. They will be instructed to avoid exercise that is not directly outlined by the experiment (see attached). Their meals will be provided by the GCRC to ensure adequate nutrition and to avoid high dietary levels of quercetin. We are currently working with BioNutrition on this menu. To ensure compliance with this diet, subjects will fill out a food diary.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quercetin | Experimental | Dietary Supplement: Quercetinnot necessary, contained in protocol |
| Placebo | Placebo comparator | Dietary Supplement: Placebonot necessary, contained in protocol |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy: 1 or less CV risk factor. Positive risk factors include:
- Male
- 18-39 years of age
- Willing to follow study diet
- Willing to exercise for prescribed time
Key exclusion criteria (4 listed)
- History of heat illness
- Current NSAID use
- Known gastrointestinal disease
- Illness (physician provide physical before subject begin each condition)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quercetin2g/d dietary quercetin supplementation, 1g taken am; 1g taken pm | Dietary supplement | Quercetin |
| PlaceboPlacebo, performed on same subjects as Quercetin Arm, used to compare results between conditions | Dietary supplement | Placebo |
Primary outcome
Urinary Lactulose Excretion
Time frame: Baseline
Lactulose is a large molecule (disaccharide: 242 kDa) that should not be permeable to the gastrointestinal barrier under normal conditions. Subjects will ingest a test solution containing 10 g lactulose (Quintron Instrument Company, QT02500-10-5, Milwaukee, WI, USA) dissolved in 50 ml of distilled water. This is followed by 8 hour urine collection.
Plasma endotoxin
Time frame: Baseline
Plasma endotoxin will be detected with a standard limulus amebocyte lysate (LAL) kit (Cell Sciences, HIT302, Canton, MA, USA). The minimum and maximum detection limits of this kit are 1.4 pg/ml and 1,000 pg/ml, respectively.
Plasma Quercetin
Time frame: Baseline
Quercetin conjugates are hydrolysized from plasma with B-glucuronidase and arylsulfatase kit (Roche Diagnostics, 10127698001, Indianapolis, IN, USA). The resulting supernatant is applied to solid phase extraction cartridges and run through a vacuum manifold for purification. The eluent is 80% methanol / 20% 18 MOhm water. Following solid phase extraction chromatographic analysis is performed using high performance liquid chromatography (HPLC).
Plasma TNF-a
Time frame: pre, post, 2hours post, 4 hours post exercise on Day 1 of exercise/heat stress
plasma Il-6
Time frame: Pre, post, 2hours post, 4 hours post exercise, day 1 of exercise/heat stress
Plasma Il-10
Time frame: Pre, post, 2 hours post, 4 hours post exercise on Day 1 of exercise/heat stress
HSP70 content of peripheral blood mononuclear cells
Time frame: Pre, post, 2 hours post, 4 hours post exercise on day 1 of exercise/heat stress
HSF-1 content of peripheral blood mononuclear cells
Time frame: Pre, post, 2 hours post, 4 hours post exercise on day 1 of exercise/heat stress
Core temperature response to heat tolerance test
Time frame: heat tolerance test 1= before study onset
Skin temperature response to heat tolerance test
Time frame: heat tolerance test 1= before study onset
Mean body temperature response to heat tolerance test
Time frame: heat tolerance test 1= before study onset
Heart rate response to heat tolerance test
Time frame: heat tolerance test 1= before study onset
Physiological strain response to heat tolerance test
Time frame: heat tolerance test 1= before study onset
Urinary Lactulose Excretion
Time frame: Day 1 of exercise/heat stress
Urinary Lactulose Excretion
Time frame: Day 7 of exercise/heat stress
Plasma Quercetin
Time frame: Day 1 of exercise/heat stress
Plasma Quercetin
Time frame: Day 7 of exercise/heat stress
Plasma Endotoxin
Time frame: Day 1 of exercise/heat stress
plasma endotoxin
Time frame: day 7 of exercise/heat stress
Plasma TNF-a
Time frame: pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress
plasma Il-10
Time frame: pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress
plasma Il-6
Time frame: pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress
HSP70 content of peripheral blood mononuclear cells
Time frame: pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress
HSF-1 content of peripheral blood mononuclear cells
Time frame: pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress
Core temperature response to heat tolerance test
Time frame: heat tolerance trial 2 = day 6 of exercise/heat stress
Skin temperature response to heat tolerance test
Time frame: heat tolerance trial 2 = day 6 of exercise/heat stress
Mean body temperature response to heat tolerance test
Time frame: heat tolerance trial 2 = day 6 of exercise/heat stress
Heart rate response to heat tolerance test
Time frame: heat tolerance trial 2 = day 6 of exercise/heat stress
physiological strain response to heat tolerance test
Time frame: heat tolerance trial 2 = day 6 of exercise/heat stress
4 secondary outcomes
Improvements in sweat rate following heat acclimation exercise
Time frame: heat tolerance test 1= before study onset
Plasma volume expansion in response to heat acclimation exercise
Time frame: heat tolerance test 1= before study onset
Improvements in sweat rate following heat acclimation exercise
Time frame: heat tolerance trial 2 = day 6 of exercise/heat stress
plasma volume expansion in response to heat acclimation exercise
Time frame: heat tolerance trial 2 = day 6 of exercise/heat stress
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pope L Moseley, MD principal investigator
University of New Mexico, Professor and Chariman, Dpt of Internal Medicine
Matthew R. Kuennen, PhD study director
UNM Department of Health, Exercise and Sports Sciences and UNM Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quercetin in people with Heat Acclimation and Thermotolerance, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Lactulose Excretion (time frame: Baseline). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.