CALERIE: Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy

Aging Clinical Trial

Official title:

Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy (CALERIE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427193
• Other study ID #: Pro00016876
• Secondary ID: PBRC U01-AG02048
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: November 2012

Study information

• Verified date: March 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the hypothesis that two years of sustained 25% caloric restriction (CR) in men age 21-50 (inclusive) and women age 21-47 (inclusive) will slow aging and protect against age-related disease processes.

Description:

The overall aim of CALERIE Phase 2 is to test the hypothesis that two years of sustained caloric restriction (CR), involving a reduction in energy intake to 75% of baseline (25% CR), in healthy, non-obese men aged 21-50 (inclusive) and women aged 21-47 (inclusive), will result in the same adaptive changes that were observed in a wide variety of animal studies. Particular emphasis is on the adaptive responses thought to be involved in slowing the aging process and protecting against age-related disease processes. Primary outcomes include core body temperature and resting metabolic rate. Secondary outcomes include risk factors for cardiovascular disease, inflammatory markers, immune function, psychological and physical function; oxidative changes in lipids, proteins, and DNA; and, risk factors for age-related conditions such as diabetes and body composition. An important secondary aim is to identify potential adverse effects of CR in humans.

The study will be conducted as a multi-center, parallel-group, randomized, controlled trial (RCT). A sample of 200 participants will be enrolled, and assigned to either the CR intervention or a control group. Control participants will be advised to simply continue their current diets. Participants in both treatment arms will be followed over a period of 24 months. A comprehensive set of evaluations will be performed prior to initiating the intervention, with follow-up evaluations at 1, 3, 6, 9, 12, 18 and 24 months afterwards.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age must be between 21-50 (inclusive) for men and 21-47 (inclusive) for women

• Body mass index (BMI) must be greater than or equal to 22 and less than 28

• Female participants must use acceptable forms of contraception (barrier method, oral contraceptive, intra-uterine device, or similar) and be willing to continue using such a method while enrolled in the study

Exclusion Criteria:

• 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

• History or clinical manifestation of cholelithiasis (the presence or formation of gallstones in the gallbladder or bile ducts)

• History of anaphylaxis, severe allergies, or asthma

• History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer that, in opinion of the investigator, would make the candidate ineligible for the study

• 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

• Practice a vegan dietary lifestyle

• History or clinical manifestation of any eating disorder

• 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

• BDI (Beck Depression Inventory) score of 20 or higher at screening or baseline

• Treatment with steroids for more than a month within five years prior to the randomization date, or short-term (less than a month) treatment with steroids within six months prior to the randomization date

• Regular use of other medications, except contraceptives

• Participated in the CALERIE Phase 1 studies

• Lost or gained 3 kg or more over the past six months

• A volunteer must be either a never-smoker of tobacco products or an ex-smoker who quit completely at least 12 months prior to the screening visit

• Donated blood within 30 days prior to the randomization date

• Concurrent participation in any other interventional study

• Breast-feeding or pregnant women or women intending to become pregnant before the scheduled end of the intervention

• 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 period

• 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 over the entire two-year period follow-up period

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Caloric Restriction (CR)
Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
• Control
Participants continue their current diet for 24 months

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Jean Mayer Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Belsky DW, Huffman KM, Pieper CF, Shalev I, Kraus WE. Change in the Rate of Biological Aging in Response to Caloric Restriction: CALERIE Biobank Analysis. J Gerontol A Biol Sci Med Sci. 2017 Dec 12;73(1):4-10. doi: 10.1093/gerona/glx096. — View Citation

Martin CK, Bhapkar M, Pittas AG, Pieper CF, Das SK, Williamson DA, Scott T, Redman LM, Stein R, Gilhooly CH, Stewart T, Robinson L, Roberts SB; Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) Phase 2 Study Group. Effec — View Citation

Racette SB, Rochon J, Uhrich ML, Villareal DT, DAS SK, Fontana L, Bhapkar M, Martin CK, Redman LM, Fuss PJ, Roberts SB, Kraus WE. Effects of Two Years of Calorie Restriction on Aerobic Capacity and Muscle Strength. Med Sci Sports Exerc. 2017 Nov;49(11):22 — View Citation

Ravussin E, Redman LM, Rochon J, Das SK, Fontana L, Kraus WE, Romashkan S, Williamson DA, Meydani SN, Villareal DT, Smith SR, Stein RI, Scott TM, Stewart TM, Saltzman E, Klein S, Bhapkar M, Martin CK, Gilhooly CH, Holloszy JO, Hadley EC, Roberts SB; CALER — View Citation

Rochon J, Bales CW, Ravussin E, Redman LM, Holloszy JO, Racette SB, Roberts SB, Das SK, Romashkan S, Galan KM, Hadley EC, Kraus WE; CALERIE Study Group. Design and conduct of the CALERIE study: comprehensive assessment of the long-term effects of reducing — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Fat Mass	Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) was determined for the whole body.	change 0 to 24 months
Other	Change in Fat Mass	Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) was determined for the whole body.	baseline, 12 months
Primary	Change in Core Body Temperature, Baseline to 12 Months		Baseline to 12 months
Primary	Change in Core Temperature, Baseline to 24 Months		Baseline to 24 months
Primary	Change in Resting Metabolic Rate (RMR) Corrected for Changes in Body Composition, Baseline to 12 Months		Baseline, 12 months
Primary	Change in Resting Metabolic Rate (RMR) Corrected for Changes in Body Composition		Baseline, 24 months
Secondary	Change in Tumor Necrosis Factor-a (TNF-a), Baseline to 12 Months		change baseline to 12 months

External Links

•   CALERIE website