NCT01168739

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

July 20, 2010

Last Update Submit

March 9, 2024

Conditions

Heat Acclimation and Thermotolerance

Keywords

thermotoleranceheat acclimationquercetinexertional heat illnessgastrointestinal barrier permeability

Outcome Measures

Primary Outcomes (29)

  • 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.

    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.

    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).

    Baseline

  • Plasma TNF-a

    pre, post, 2hours post, 4 hours post exercise on Day 1 of exercise/heat stress

  • plasma Il-6

    Pre, post, 2hours post, 4 hours post exercise, day 1 of exercise/heat stress

  • Plasma Il-10

    Pre, post, 2 hours post, 4 hours post exercise on Day 1 of exercise/heat stress

  • HSP70 content of peripheral blood mononuclear cells

    Pre, post, 2 hours post, 4 hours post exercise on day 1 of exercise/heat stress

  • HSF-1 content of peripheral blood mononuclear cells

    Pre, post, 2 hours post, 4 hours post exercise on day 1 of exercise/heat stress

  • Core temperature response to heat tolerance test

    heat tolerance test 1= before study onset

  • Skin temperature response to heat tolerance test

    heat tolerance test 1= before study onset

  • Mean body temperature response to heat tolerance test

    heat tolerance test 1= before study onset

  • Heart rate response to heat tolerance test

    heat tolerance test 1= before study onset

  • Physiological strain response to heat tolerance test

    heat tolerance test 1= before study onset

  • Urinary Lactulose Excretion

    Day 1 of exercise/heat stress

  • Urinary Lactulose Excretion

    Day 7 of exercise/heat stress

  • Plasma Quercetin

    Day 1 of exercise/heat stress

  • Plasma Quercetin

    Day 7 of exercise/heat stress

  • Plasma Endotoxin

    Day 1 of exercise/heat stress

  • plasma endotoxin

    day 7 of exercise/heat stress

  • Plasma TNF-a

    pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress

  • plasma Il-10

    pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress

  • plasma Il-6

    pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress

  • HSP70 content of peripheral blood mononuclear cells

    pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress

  • HSF-1 content of peripheral blood mononuclear cells

    pre, post, 2hours post, 4 hours post exercise on Day 7 of exercise/heat stress

  • Core temperature response to heat tolerance test

    heat tolerance trial 2 = day 6 of exercise/heat stress

  • Skin temperature response to heat tolerance test

    heat tolerance trial 2 = day 6 of exercise/heat stress

  • Mean body temperature response to heat tolerance test

    heat tolerance trial 2 = day 6 of exercise/heat stress

  • Heart rate response to heat tolerance test

    heat tolerance trial 2 = day 6 of exercise/heat stress

  • physiological strain response to heat tolerance test

    heat tolerance trial 2 = day 6 of exercise/heat stress

Secondary Outcomes (4)

  • Improvements in sweat rate following heat acclimation exercise

    heat tolerance test 1= before study onset

  • Plasma volume expansion in response to heat acclimation exercise

    heat tolerance test 1= before study onset

  • Improvements in sweat rate following heat acclimation exercise

    heat tolerance trial 2 = day 6 of exercise/heat stress

  • plasma volume expansion in response to heat acclimation exercise

    heat tolerance trial 2 = day 6 of exercise/heat stress

Study Arms (2)

Quercetin

EXPERIMENTAL

not necessary, contained in protocol

Dietary Supplement: Quercetin

Placebo

PLACEBO COMPARATOR

not necessary, contained in protocol

Dietary Supplement: Placebo

Interventions

QuercetinDIETARY_SUPPLEMENT

2g/d dietary quercetin supplementation, 1g taken am; 1g taken pm

Quercetin
PlaceboDIETARY_SUPPLEMENT

Placebo, performed on same subjects as Quercetin Arm, used to compare results between conditions

Placebo

Eligibility Criteria

Age18 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • Low VO2 peak: \<40ml/kg/min
  • Overfatness(BMI\>30 kg/m2 and/or body fat \> 25%)
  • Male
  • 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

You may not qualify if:

  • History of heat illness
  • Current NSAID use
  • Known gastrointestinal disease
  • Illness (physician provide physical before subject begin each condition)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNM General Clinical Research Center

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Heat Stress Disorders

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

FlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pope L Moseley, MD

    University of New Mexico, Professor and Chariman, Dpt of Internal Medicine

    PRINCIPAL INVESTIGATOR

  • Matthew R. Kuennen, PhD

    UNM Department of Health, Exercise and Sports Sciences and UNM Department of Internal Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 23, 2010

Study Start

September 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

US(1)