NCT00183027

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

November 9, 2006

Status Verified

November 1, 2006

First QC Date

September 13, 2005

Last Update Submit

November 8, 2006

Conditions

Obesity

Keywords

Dietary restrictionCaloric restriction

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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

Interventions

Dietary composition and energy intakeBEHAVIORAL

Eligibility Criteria

Age20 Years - 42 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women (based on standard laboratory tests and a screening examination)
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (9)

  • 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. doi: 10.1093/gerona/56.suppl_1.5. No abstract available.

    PMID: 12088212BACKGROUND

  • 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. doi: 10.1093/gerona/56.suppl_1.7.

    PMID: 12088215BACKGROUND

  • 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. doi: 10.1093/gerona/56.suppl_1.20.

    PMID: 12088209BACKGROUND

  • 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. doi: 10.1093/gerona/56.suppl_1.34.

    PMID: 12088210BACKGROUND

  • 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. doi: 10.1093/gerona/56.suppl_1.45.

    PMID: 12088211BACKGROUND

  • 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. doi: 10.1093/gerona/56.suppl_1.55.

    PMID: 12088213BACKGROUND

  • 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. doi: 10.1093/oxfordjournals.aje.a117664.

    PMID: 7677127BACKGROUND

  • 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. doi: 10.2337/diacare.28.12.2939. No abstract available.

    PMID: 16306558RESULT

  • 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(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

    PMID: 33512717DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Energy Intake

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Susan B. Roberts, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

November 1, 2002

Study Completion

December 1, 2004

Last Updated

November 9, 2006

Record last verified: 2006-11

Locations

US(1)