Status:
COMPLETED
Developing Biomarkers of Dietary Intake
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diet Therapy
Healthy Volunteers
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
Background: \- Researchers who study health and nutrition are interested in developing more accurate methods of determining what people eat from day to day and how it affects their general health. In...
Detailed Description
Studies of health and nutrition use a variety of tools to determine what people eat from day to day. Unfortunately, most of the methods used are not accurate for a variety of reasons and do not provid...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Body mass index less than or equal to 35 kg/m(2) to minimize the impact of body size on isotope measurements.
- Males 18-65 years old will be recruited for this study. Minors under the age of 18 will be excluded because the time requirements of the study are such that they would interfere with school schedules.
- Healthy, as determined by medical history, physical examination, and laboratory tests.
- EXCLUSION CRITERIA:
- Current smoking
- Female sex
- Baldness or hair less than 2 cm in length
- Medically- or self-imposed dietary restrictions that would limit a participant s ability/willingness to consume the diet to which they are randomized.
- Type 2 diabetes (according to the World Health Organization diagnostic criteria)
- Endocrine disorders (Cushing s Disease, pituitary disorders, and hypo- and hyperthyroidism)
- Chronic pulmonary disorders, including chronic obstructive pulmonary disease, that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study (provided use of these agents is not required for one week before study entry).
- Cardiovascular diseases (coronary heart disease, heart failure, arrhythmias, and peripheral artery disease)
- Hypertension (blood pressure measurement higher than 140/90 mm Hg on two or more occasions or use of anti-hypertensive medications)
- Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g., Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g., celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study
- Presence of a pacemaker or other implantable devices
- Liver disease (cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 1.5 x normal)
- Renal disease (serum creatinine concentrations greater than or equal to 1.5 mg/dl and/or greater than 100mg/dl of protein based on urine dipstick)
- Central nervous system disease (cerebrovascular accidents, dementia, and neurodegenerative disorders)
- Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis
- Alcohol (more than 3 drinks per day) and/or drug abuse (such as amphetamines, cocaine, heroin, or marijuana)
- Current or past history of: bipolar disorder, schizophrenia or presence of psychotic symptoms, bulimia nervosa or anorexia nervosa, or current major depressive disorder
- Weight change of plus or minus 5% in the last 3 months
- Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators. Additionally, potential subjects might be excluded if they demonstrate a style of interpersonal relationships that would inhibit successful completion of the study.
- Non-English speaking subjects as a population will be excluded from participation in this protocol. One of the secondary hypotheses of the protocol relates to a battery of psychological questionnaires and performances tests which are administered to the volunteers at the beginning and end of the study. There are currently no validated, translated forms of these questionnaires and tests available; therefore we will restrict enrollment to English speaking subjects only.
Exclusion
Key Trial Info
Start Date :
October 24 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01237093
Start Date
October 24 2010
End Date
March 31 2020
Last Update
December 31 2025
Active Locations (1)
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1
NIDDK, Phoenix
Phoenix, Arizona, United States, 85014