AgingNCT01922973
Effect of Fasting on Ghrelin and Growth Hormone in Healthy Young and Older Adults
An observational study of Aging, run by University of Virginia.
Trial summary
The overall objective of this study is to determine the extent to which circulating ghrelin levels (total and bioactive ghrelin) are regulated by nutritional state and age. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Fasting
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Dec 2004
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: normal volunteers
Who may be able to join
- Healthy young (ages 18-30) and older (ages > 60) men and women with a body mass index (BMI) of <35 kg/m2. Young and older subjects will be matched for BMI.
Who cannot join
- A history of coronary artery disease, congestive heart failure, peripheral vascular disease, diabetes mellitus, significant hypertension (BP >180 systolic or >100 diastolic at rest); renal, hepatic, pulmonary disease; untreated hypothyroidism, untreated hyperthyroidism; history of seizure disorder; history of malignancy (other than some skin cancers), history of active chronic infections (e.g., HIV, tuberculosis): abnormal screening laboratory tests. This information will be obtained through the use of screening labs, history and physical exam and the medical record. See the GCRC protocol for details of the labs.
- Hematocrit < 41% men, < 38% women
- History of daily tobacco use within past 3 months
- Chronic alcohol abuse
- Recent weight change of > 10 pounds in last 3 months
- Strenuous exercise for average of more than 60 min/day
Show all 9Show fewer
- Investigational drug within past 6 weeks
- Any history of major psychosis, severe depression, anorexia nervosa
- Transmeridian travel within 2 weeks prior to or during study -
About this study
The overall objective of this study is to determine the extent to which circulating ghrelin levels (total and bioactive ghrelin) are regulated by nutritional state and age.
Read the detailed description
Normal volunteers: young and older men and women studied under fed and fasting (total 62.5h) conditions, frequent blood sampling for ghrelin and other related hormones
- Conditions
- Aging
- Being tested
- Fasting
- Keywords
- ghrelin, growth hormone, aging, normal volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
normal volunteers fast from food on one occasion for 62.5 h; on another occasion fed 3 meals
| Study group | Role | What they receive |
|---|---|---|
| normal men and women | normal volunteers: young and older men and women studied under fed and fasting (62.5h) conditions with frequent blood sampling for ghrelin and related hormones Receives: Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ghrelin concentration
Measured: 24-h mean
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startMay 2003
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Thorner, MD, University of Virginia
- Investigators
- Michael O Thorner, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922973
- Sponsor's protocol ID
- 10619
- Status last verified
- Aug 2013
- First submitted
- 12 Aug 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fasting on Ghrelin and Growth Hormone in Healthy Young and Older Adults
- ClinicalTrials.gov ID
- NCT01922973
- Acronym / sponsor ID
- 10619
- Conditions
- Aging
- Keywords
- ghrelin, growth hormone, aging, normal volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 14 Aug 2013 (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.
The overall objective of this study is to determine the extent to which circulating ghrelin levels (total and bioactive ghrelin) are regulated by nutritional state and age.
Detailed description
Normal volunteers: young and older men and women studied under fed and fasting (total 62.5h) conditions, frequent blood sampling for ghrelin and other related hormones
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| normal men and women | – | Other: Fastingnormal volunteers: young and older men and women studied under fed and fasting (62.5h) conditions with frequent blood sampling for ghrelin and related hormones |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- normal volunteers
Key inclusion criteria (1 listed)
- Healthy young (ages 18-30) and older (ages > 60) men and women with a body mass index (BMI) of <35 kg/m2. Young and older subjects will be matched for BMI.
Key exclusion criteria (9 listed)
- A history of coronary artery disease, congestive heart failure, peripheral vascular disease, diabetes mellitus, significant hypertension (BP >180 systolic or >100 diastolic at rest); renal, hepatic, pulmonary disease; untreated hypothyroidism, untreated hyperthyroidism; history of seizure disorder; history of malignancy (other than some skin cancers), history of active chronic infections (e.g., HIV, tuberculosis): abnormal screening laboratory tests. This information will be obtained through the use of screening labs, history and physical exam and the medical record. See the GCRC protocol for details of the labs.
- Hematocrit < 41% men, < 38% women
- History of daily tobacco use within past 3 months
- Chronic alcohol abuse
- Recent weight change of > 10 pounds in last 3 months
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 |
|---|---|---|
| Fastingnormal volunteers fast from food on one occasion for 62.5 h; on another occasion fed 3 meals | Other | normal men and women |
Primary outcome
Ghrelin concentration
Time frame: 24-h mean
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 14 Aug 2013.
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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.
Michael O Thorner, MD principal investigator
University of Virginia
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by University of Virginia.
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 1 inclusion and 9 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 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
What does the primary outcome measure?
Ghrelin concentration (time frame: 24-h mean). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2013.