CALERIE Phase II Ancillary: Metabolic

Completed · Phase 2

Conditions studied: Aging

In brief

The primary aim of this NIA sponsored ancillary study of phase 2 CALERIE is to measure whether metabolic adaptation lasts up to 2 years in response to a 25% calorie restriction in normal-weight and slightly overweight individuals. Energy metabolism (24-hour sedentary and sleeping) will be measured in a respiratory chamber. Other measures include the activities of the sympathetic nervous and thyroid axes, oxidative stress in lipids, protein and DNA, organ size by MRI and echocardiography, and posture allocation (time spent engaging in different activities and the energy expended during these activities), and activity temperament (the innate predilection for movement). This set of studies will allow assessment of whether the previously observed metabolic adaptation in response to 25% caloric restriction is long lasting (up to two years), associated with reduced thyroid and sympathetic activities and reduced oxidative damage. The studies of organ sizes (liver, spleen, kidney, heart, adipose and muscle) by MRI and echo (heart) is essential to determine whether the metabolic adaptation is related to decreased organ sizes or improved organ energy metabolism efficiency. The above described measures will be performed at baseline and after 1 and 2 years of a 25% caloric restriction in 50 non-obese humans and in 25 sex-, BMI- and age- matched subjects who will not engage in caloric restriction.

Key facts

Study ID

NCT02695511

Run by

Pennington Biomedical Research Center

People needed

75

Starts

2007-05-01

Expected to finish

2010-02-01

Last updated by the study team

2016-03-01

Who can join

Age: 25 and older, up to 46. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy men and women
• > 22 BMI < 28 kg/m2
• > 25 age < 46

You may not qualify if…

• History or clinical manifestation of cardiovascular disease or an elevated blood pressure (greater than 140/90 mm Hg)
• Abnormal resting ECG
• History or clinical manifestation of diabetes, cholelithiasis or any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, eating disorders or cancer
• History of stomach or intestinal surgery (except appendectomy) or major abdominal, thoracic or non-peripheral vascular surgery within one year prior to the randomization date
• Any disease or condition that seriously affects body weight and/or body composition
• Potassium level above the upper limit of normal at the screening visit confirmed by a test repeated within two weeks
• Hemoglobin, hematocrit, RBC, or iron level below the lower limit of normal at the screening visit confirmed by a test repeated within two weeks
• Evidence of active liver disease or ALT levels above 1.5 times the upper limit of normal
• Any history of pharmacologic treatment for a psychiatric disorder within one year prior to the randomization date or a history of more than one episode of a pharmacologic treatment for a psychiatric disorder within lifetime
• History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years
• Individuals who present with a BDI score of =15 at screening or baseline
• Short-term (less than a month) treatment with steroids within six months prior to the randomization date
• Treatment with steroids for more than a month within five years prior to the randomization date
• Regular use of other medications, except oral contraceptives
• Individuals who participated in the CALERIE Phase 1 studies
• A volunteer must be either be a never-smoker of tobacco products or an ex-smoker who quit completely at least 12 months prior to the screening visit
• Individuals who have magnetic metallic objects in their body
• Individuals who donated blood within 30 days prior to the randomization date
• Concurrent participation in any other interventional study
• Pregnant or breast-feeding women
• Individuals who were engaged in a regular program of physical fitness involving some kind of heavy physical activity (e.g., jogging, running or riding fast on a bicycle for 30 minutes or more) five or more times per week over the past year
• Unwilling to be assigned at random to the CR or control intervention
• Unwilling or unable to adhere to the rigors of the CR intervention over the entire two-year intervention
• Individuals who unable or unwilling to discontinue dietary supplements or adhere to the alcohol consumption restrictions during the study
• Unwilling or unable to adhere to the rigors of the data collection and clinical evaluation schedule

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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