Phase
Condition
Metabolic Syndrome
Diabetes Prevention
Obesity
Treatment
Exercise
Clinical Study ID
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who are between 18 - 60 years of age
Body mass index values will range from >25.0 to < 32.0 kg/m2, making them qualifiedas an overweight-to-obese population (https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm)
Average body mass index for entire study cohort will be less than 30.0 kg/m2. Assuch an ongoing calculation of the recruited cohort's mean body mass index will bemaintained and people will only be randomized into the study if the average cohortbody mass index value does not exceed 30.0 kg/m2
Free-living/uninhibited with use of ambulatory assistive devices (e.g. canes,crutches, walkers, etc.) and independent
In good health absent of being overweight or mildly obese with no other signs orsymptoms of cardiovascular, respiratory, metabolic, immune, psychiatric, ormusculoskeletal disease or disorders
Willingness to maintain consistent sleep duration the evening before study visits
Willing and able to agree to the requirements and restrictions of this study, bewilling to give voluntary consent, and carry out all study-related procedures
Able to complete a peak oxygen consumption exercise test with no contraindicationsto perform exercise per standards put forth by the American College of SportsMedicine. In other words, they are able to safety complete maximal exercise.
Exclusion
Exclusion Criteria:
Positive medical history and/or is currently being treated for some form of heartdisease, cardiovascular disease
Currently being treated for kidney disease, renal failure, or has dialysis performedon regular intervals
Has liver disease or some form of clinically diagnosed hepatic impairment
Diagnosed with having Type I or Type II diabetes (determined as fasting bloodglucose > 126 mg/dL)
Diagnosed with or is being treated for some form of thyroid disease
Diagnosed with major affective disorder or other psychiatric disorder that requiredhospitalization in the prior year
Diagnosed with some form of immune disorder (i.e., HIV/AIDS)
History of cancer (except localized skin cancer without metastases or in situcervical cancer within 5 years prior to screening visit).
Participant has an abnormality or obstruction of the gastrointestinal tractprecluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinalmalabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis,steatorrhea)
Positive medical history for any neurological condition or neurological disease
Currently prescribed a statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) orany hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers,Vasodilators, etc.)
Current smoker (average of > 1 pack per day within the past 3 months) has quitwithin the past six months. This includes all forms of nicotine
Intake of any drugs (prescribed or over the counter) or dietary supplements that areknown or are purported to weight loss such as thermogenics, hydroxycitric acid,ephedra, capsaicin, etc.
Participants who are lactating, pregnant or planning to become pregnant
Have a known sensitivity or allergy to any of the study products
History of alcohol or substance abuse in the 12 months prior to screening
Receipt or use of an investigational product in another research study within 30days of beginning the study protocol
They plan major changes in lifestyle (i.e., diet, dieting, exercise level, travel,etc.) during the study
Recent history (<3 months) of exercise training or weight loss (> 5%)
Any orthopedic limitation that would prevent participation in a general fitnessprogram
Any condition or abnormality that, in the opinion of the investigator, wouldcompromise the safety of the participant or the quality of the study data
Study Design
Study Description
Connect with a study center
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri 63301
United StatesSite Not Available
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