Dietary Energy Restriction and Metabolic Aging in Humans

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ClinicalTrials.gov Identifier: NCT00183027

Recruitment Status : Completed

First Posted : September 16, 2005

Last Update Posted : November 9, 2006

Sponsor:

Information provided by:

National Institute on Aging (NIA)

Study Description

Brief Summary:

The purpose of this study is to develop an effective calorie restricted diet.

Condition or disease	Intervention/treatment	Phase
Obesity	Behavioral: Dietary composition and energy intake	Not Applicable

Detailed Description:

This study is a 3-phase investigation designed to test two caloric restriction (CR) regimens for participant compliance and variability in metabolic and physiologic effects. Initially, and through phase 1 (1 week pre-phase, and 6 weeks phase 1), participants will maintain normal habits at home.

Then for phase 2 (24 weeks), the 44 participants will be randomized to one of two diets (Diet HG or Diet LG), which they will consume at either 70% or 90% of baseline energy intake. The participants randomized to 90% CR (both diets) will form the control group. All food will be provided during this phase, and participants will be required to attend weekly group or individual meetings with the behavioral counselor and dietitian, and perform regular self-monitoring.

During phase 3 (24 weeks), participants will prepare their own food at home according to their CR regimen and will eat to maintain the CR specified for phase 2. They will continue to attend the weekly meetings and to perform self-monitoring.

Diet HG: a diet based on the USDA Food Guide Pyramid, but with additional emphasis on adequate fiber and low energy density foods, including use of whole grains rather than refined carbohydrates, limited liquid calories, high variety of low energy items such as fruits and vegetables and low variety of high-energy discretionary foods.

Diet LG: a modification of the HG diet in which low energy density is maintained even though the percent of energy from fat and protein is increased (by increased use of high-protein foods and foods with high water content) and use of different carbohydrate sources and physically intact food items (whole grains, raw fruits and vegetables) to further lower glycemic load through reducing the glycemic index (GI). High fiber intakes, low energy density, limited use of liquid calories, high variety of low energy items such as fruits and vegetables and low variety of high-energy discretionary foods will be the same as for the HG diet.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	44 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Dietary Energy Restriction and Metabolic Aging in Humans
Study Start Date :	November 2002
Study Completion Date :	December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Older Adult Health

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Changes in body weight, body fatness and total energy expenditure at baseline, 3, 6, and 12 months of caloric restriction (CR).

Secondary Outcome Measures :

Changes in blood pressure, insulin sensitivity and secretion, resting metabolic rate, bone mineral density, disease incidence, cognitive function, immune function, oxidative stress parameters, fertility hormones at baseline, 6, and 12 months

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 42 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy men and women (based on standard laboratory tests and a screening examination)
20-42 years of age
BMI in the range 25-29.9 kg/m2
Proportional representation of minorities in the Greater Boston Area (7 percent Black, 11 percent Hispanic, 82 percent non-Hispanic white)
Able to accurately complete a food record
Stage of change >1 for weight loss and changing dietary intake
Must have an immediate adult family member who is supportive of weight loss

Exclusion Criteria:

Known serious disorders that affect longevity, energy metabolism, body composition and immune responsiveness, including diabetes, cancer, heart disease, cachexia, eating disorders (anorexia and bulimia and any vomiting for means of weight control), depression, alcoholism, inflammatory disorders and AIDS, and individuals taking medicine that is anticipated to influence lifespan or energy metabolism
Abnormal kidney function as assessed by serum creatinine, BUN and urinalysis, and abnormal liver function as assessed by SGPT, SGOT alkaline phosphatase, and bilirubin, abnormal normal thyroid function as assessed by serum T4 and TSH and fasting serum glucose levels <125 mg/dl
Smoking, highly restrained eating, reported endurance training (participation in sports or training >12 hours per week), alcohol intake of 14 oz. per week or more, major medical and/or psychiatric disorders, plans to have a child within 3 years (1 year for Pilot study), past childbearing (for women) within the last 2 years, or breastfeeding within the past year
Amputees
Have required treatment for any psychiatric disorder
Gained or lost >15 lb weight within the past year, or taking medications known or suspected to have an important influence on lifespan, energy metabolism, body composition or immune function
Early death from cardiovascular diseases, cancer, or a diabetes-related illness (before the age of 45 years) in one or both of the parents
Unable to remain in the program for at least 1 year, or unsuitable for home-based programs (including individuals reporting binge eating disorders or clinical depression, and women intending to become pregnant)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183027

Locations

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United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

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Principal Investigator:	Susan B. Roberts, PhD	Tufts University

More Information

Publications of Results:

Pittas AG, Das SK, Hajduk CL, Golden J, Saltzman E, Stark PC, Greenberg AS, Roberts SB. A low-glycemic load diet facilitates greater weight loss in overweight adults with high insulin secretion but not in overweight adults with low insulin secretion in the CALERIE Trial. Diabetes Care. 2005 Dec;28(12):2939-41.

Other Publications:

Hadley EC, Dutta C, Finkelstein J, Harris TB, Lane MA, Roth GS, Sherman SS, Starke-Reed PE. Human implications of caloric restriction's effects on aging in laboratory animals: an overview of opportunities for research. J Gerontol A Biol Sci Med Sci. 2001 Mar;56 Spec No 1:5-6.

Lee IM, Blair SN, Allison DB, Folsom AR, Harris TB, Manson JE, Wing RR. Epidemiologic data on the relationships of caloric intake, energy balance, and weight gain over the life span with longevity and morbidity. J Gerontol A Biol Sci Med Sci. 2001 Mar;56 Spec No 1:7-19. Review.

Weindruch R, Keenan KP, Carney JM, Fernandes G, Feuers RJ, Floyd RA, Halter JB, Ramsey JJ, Richardson A, Roth GS, Spindler SR. Caloric restriction mimetics: metabolic interventions. J Gerontol A Biol Sci Med Sci. 2001 Mar;56 Spec No 1:20-33. Review.

Mobbs CV, Bray GA, Atkinson RL, Bartke A, Finch CE, Maratos-Flier E, Crawley JN, Nelson JF. Neuroendocrine and pharmacological manipulations to assess how caloric restriction increases life span. J Gerontol A Biol Sci Med Sci. 2001 Mar;56 Spec No 1:34-44. Review.

Poehlman ET, Turturro A, Bodkin N, Cefalu W, Heymsfield S, Holloszy J, Kemnitz J. Caloric restriction mimetics: physical activity and body composition changes. J Gerontol A Biol Sci Med Sci. 2001 Mar;56 Spec No 1:45-54. Review.

Allison DB, Miller RA, Austad SN, Bouchard C, Leibel R, Klebanov S, Johnson T, Harrison DE. Genetic variability in responses to caloric restriction in animals and in regulation of metabolism and obesity in humans. J Gerontol A Biol Sci Med Sci. 2001 Mar;56 Spec No 1:55-65. Review.

Felson DT, Zhang Y, Hannan MT, Kannel WB, Kiel DP. Alcohol intake and bone mineral density in elderly men and women. The Framingham Study. Am J Epidemiol. 1995 Sep 1;142(5):485-92.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1:CD013496. doi: 10.1002/14651858.CD013496.pub2.

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ClinicalTrials.gov Identifier:	NCT00183027
Other Study ID Numbers:	AG0044 3U01AG020480 ( U.S. NIH Grant/Contract )
First Posted:	September 16, 2005 Key Record Dates
Last Update Posted:	November 9, 2006
Last Verified:	November 2006

Keywords provided by National Institute on Aging (NIA):


Dietary restriction Caloric restriction

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