AgingPhase 1NCT00099099
CALERIE (Tufts) - Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy
A Phase 1 study testing Caloric Restriction (CR) in people with Aging, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet increases the length of life and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Caloric Restriction (CR)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Dec 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Body mass index (BMI) = 25-30
- Slightly overweight, < 275 lbs
- Women 25-45, pre-menopause
- Men 25-50
- Not traveling often or planning to move
Show all 24Show fewer
- Exclusions:
- Cardiovascular disease or blood pressure greater than 160/90
- Diabetes
- Major psychiatric disorders
- Eating disorders
- Post obese; previous BMI > 32
- Weight change of more than ten pounds in the past 90 days
- Over 275 pounds
- Smoking
- Regular exercise, more than twice per week
- Current prescription drug use, except oral contraceptives
- Alcoholism or substance abuse
- Pregnant or lactating (breast feeding), planning to become pregnant, or not regularly using contraception
- Abnormal electrocardiogram (EKG)
- Local resident for less than one year
- Occupations requiring full alertness and motor skills, with no allowance for a chance of postural dizziness (airline pilots, etc.)
- Injuries by any metallic object that is still present in the body
- Braces, non-removable dentures, or non-removable bridgework
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111-1524
About this study
Official title: Dietary Energy Restriction and Metabolic Aging in Humans
This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet increases the length of life and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are participating in the CALERIE trial represent a diversity of subject populations and interventional strategies.
Read the detailed description
Researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University are enrolling overweight men and women aged 20-42 in a 1-year study to develop an effective calorie restricted regimen that minimizes hunger and prevents weight regain. The study also examines the effects of weight loss on body composition, metabolism and aging. Two different diets containing usual foods and a healthy balance of nutrients will be tested at 2 levels of caloric restriction, 10% and 30% (in other words, 90% or 70% of what one would normally eat). Weight loss is expected for most volunteers participating in this study, but cannot be guaranteed.
- Conditions
- Aging
- Being tested
- Caloric Restriction (CR)
- Keywords
- Longevity, Calorie restriction, Physical activity, Weight loss
- Medical subject headings
- Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric Restriction (CR)Behavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2004 (estimated)
- Study startMar 2002
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 44 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan B. Roberts, PhD, Principal investigator, Jean Mayer USDA HNRCA at Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099099
- Sponsor's protocol ID
- AG0006
- Other IDs
- 3U01AG020480
- Status last verified
- Feb 2006
- First submitted
- 8 Dec 2004
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
Karl JP, Cheatham RA, Das SK, Hyatt RR, Gilhooly CH, Pittas AG, Lieberman HR, Lerner D, Roberts SB, Saltzman E. Effect of glycemic load on eating behavior self-efficacy during weight loss. Appetite. 2014 Sep;80:204-11. doi: 10.1016/j.appet.2014.05.017. Epub 2014 May 21.
PubMed 24859114Racette SB, Das SK, Bhapkar M, Hadley EC, Roberts SB, Ravussin E, Pieper C, DeLany JP, Kraus WE, Rochon J, Redman LM; CALERIE Study Group. Approaches for quantifying energy intake and %calorie restriction during calorie restriction interventions in humans: the multicenter CALERIE study. Am J Physiol Endocrinol Metab. 2012 Feb 15;302(4):E441-8. doi: 10.1152/ajpendo.00290.2011. Epub 2011 Nov 29.
PubMed 22127229
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Energy Restriction and Metabolic Aging in Humans
- ClinicalTrials.gov ID
- NCT00099099
- Acronym / sponsor ID
- AG0006
- Conditions
- Aging
- Keywords
- Longevity, Calorie restriction, Physical activity, Weight loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Mar 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 9 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet increases the length of life and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are participating in the CALERIE trial represent a diversity of subject populations and interventional strategies.
Detailed description
Researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University are enrolling overweight men and women aged 20-42 in a 1-year study to develop an effective calorie restricted regimen that minimizes hunger and prevents weight regain. The study also examines the effects of weight loss on body composition, metabolism and aging. Two different diets containing usual foods and a healthy balance of nutrients will be tested at 2 levels of caloric restriction, 10% and 30% (in other words, 90% or 70% of what one would normally eat). Weight loss is expected for most volunteers participating in this study, but cannot be guaranteed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Healthy men and women
- Body mass index (BMI) = 25-30
- Slightly overweight, < 275 lbs
- Women 25-45, pre-menopause
- Men 25-50
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric Restriction (CR) | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
- Derived from this study: PubMed 24859114Karl JP, Cheatham RA, Das SK, Hyatt RR, Gilhooly CH, Pittas AG, Lieberman HR, Lerner D, Roberts SB, Saltzman E. Effect of glycemic load on eating behavior self-efficacy during weight loss. Appetite. 2014 Sep;80:204-11. doi: 10.1016/j.appet.2014.05.017. Epub 2014 May 21.
- Derived from this study: PubMed 22127229Racette SB, Das SK, Bhapkar M, Hadley EC, Roberts SB, Ravussin E, Pieper C, DeLany JP, Kraus WE, Rochon J, Redman LM; CALERIE Study Group. Approaches for quantifying energy intake and %calorie restriction during calorie restriction interventions in humans: the multicenter CALERIE study. Am J Physiol Endocrinol Metab. 2012 Feb 15;302(4):E441-8. doi: 10.1152/ajpendo.00290.2011. Epub 2011 Nov 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan B. Roberts, PhD principal investigator
Jean Mayer USDA HNRCA at Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Caloric Restriction (CR) in people with Aging, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00099099, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2009.