Status:
COMPLETED
The Metabolic Effects of Different Weight Loss Diets
Lead Sponsor:
Rockefeller University
Conditions:
Metabolic Syndrome X
Obesity
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Current estimates suggest that 65% of American adults are overweight or obese. Excess body weight has been associated with an increased risk of a number of metabolic abnormalities, including high bloo...
Detailed Description
BACKGROUND: Several dietary approaches, including the Dietary Approaches to Stop Hypertension study diet (the DASH diet) and the low glycemic index diet (low GI diet), may be helpful for overweight i...
Eligibility Criteria
Inclusion
- Nonsmoking men and premenopausal women, ages 18-45
- Body mass index ≥ 27 kg/m2
- Body weight \< 200 kg
- Evidence of insulin resistance, as suggested by any one of the following:
- Fasting glucose ≥ 100 mg/dL
- Impaired glucose tolerance, with a glucose concentration of ≥ 140 mg/dL 2 hours after a 75-gram oral glucose challenge
- A fasting insulin concentration ≥ 9 mIU/L
- At least two of the following:
- Waist circumference \> 35" in women or \> 40" in men
- Prehypertension or hypertension, with BP \> 120/80 mmHg but \< 145/90 mmHg on 2 antihypertensive agents or less
- TG \> 150 but \< 500 mg/dL
- HDL \< 40 mg/dL in men or \< 50 mg/dL in women
- Willingness to consume only study food and drink for the duration of the study and to be randomized to one of the three diets
- Willingness to maintain consistent intake of coffee and/or tea during the inpatient periods
- Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study, with the exception of the multivitamin supplement (Flintstones® Plus Iron.)
- Willingness to continue current antihypertensive medications at the same dose and schedule throughout the study, unless a change is advised.
- Willingness to avoid the use of non-steroidal anti-inflammatory drugs including low-dose daily aspirin, for at least ten days prior to the first admission and during each admission.
- Willingness to avoid the use of acetaminophen (Tylenol) and furosemide (Lasix) for at least 48 hours prior to and during the 24-hour urine collection.
- Willingness to avoid the use of sulfonamide antibiotics for at least 1 week prior to and during the 24-hour urine collection.
Exclusion
- Current tobacco smoking
- History of a bleeding disorder
- Findings suggestive of cardiovascular disease.
- Blood pressure ≥ 145/90 mmHg after 10 minutes of rest on two or more screening visits, or treatment with three or more antihypertensive agents at any blood pressure.
- Fasting glucose ≥ 165 mg/dL, glycosylated hemoglobin \> 8%, or any treatment with oral hypoglycemic agents, insulin sensitizing agents , insulin, incretin mimetics, amylin analogues, or endocannabinoid receptor antagonists.
- History of chronic glucocorticoid use, oral glucocorticoid use for more than 5 days in the previous year, or anticipated treatment with oral or intravenous glucocorticoids during the study period.
- Current treatment with weight loss medications.
- History of bariatric surgery
- Current treatment with any cholesterol-lowering medications.
- Hyperthyroidism or untreated hypothyroidism.
- Pregnancy, desired pregnancy, or lactation within the study period.
- Peri- or postmenopausal status.
- Obstructive sleep apnea.
- Active gallstone disease
- Known history of chronic hepatitis, or liver enzymes more than 2.5 times the upper limit of normal
- Known infection with HIV or confirmed positive test for HIV antibody
- Inflammatory bowel disease, active cancer, or any other medical condition that may cause significant acute weight loss or gain
- Sustained weight loss \> 5% of body weight in the previous two months, or sustained weight loss \> 10% of body weight in the previous six months
- History of kidney stones
- Renal disease, as evidenced by a serum creatinine above the normal limit on more than one screening visit
- Serum calcium, potassium, or magnesium above the normal limit, confirmed on two screening tests
- Seizure disorder
- History of any inpatient psychiatric admission within the past two years
- History of schizophrenia, psychosis, or bipolar disorder
- History of anorexia nervosa or bulimia nervosa or a history of medical or psychological treatment for an eating disorder
- Severe binge eating disorder
- Active moderate to severe depression.
- History of alcohol or drug abuse within the previous two years
- History, physical, or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the principal investigator, make the candidate ineligible for the study
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00422630
Start Date
October 1 2007
End Date
February 1 2010
Last Update
October 13 2011
Active Locations (1)
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1
Rockefeller University Hospital
New York, New York, United States, 10021