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Effect of Fasting on Ghrelin and Growth Hormone in Healthy Young and Older Adults

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ClinicalTrials.gov Identifier: NCT01922973
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
Michael Thorner, MD, University of Virginia

Brief 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.

Condition or disease Intervention/treatment
Aging Other: Fasting

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

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Study Type : Observational
Actual Enrollment : 21 participants
Time Perspective: Prospective
Official Title: Effect of Fasting on Ghrelin and Growth Hormone in Healthy Young and Older Adults
Study Start Date : May 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort Intervention/treatment
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
Other: Fasting
normal volunteers fast from food on one occasion for 62.5 h; on another occasion fed 3 meals




Primary Outcome Measures :
  1. Ghrelin concentration [ Time Frame: 24-h mean ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
normal volunteers
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  1. 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.
  2. Hematocrit < 41% men, < 38% women
  3. History of daily tobacco use within past 3 months
  4. Chronic alcohol abuse
  5. Recent weight change of > 10 pounds in last 3 months
  6. Strenuous exercise for average of more than 60 min/day
  7. Investigational drug within past 6 weeks
  8. Any history of major psychosis, severe depression, anorexia nervosa
  9. Transmeridian travel within 2 weeks prior to or during study -

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): NCT01922973


Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Michael O Thorner, MD University of Virginia

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Responsible Party: Michael Thorner, MD, Professor of Medicine, University of Virginia
ClinicalTrials.gov Identifier: NCT01922973     History of Changes
Other Study ID Numbers: 10619
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: August 14, 2013
Last Verified: August 2013

Keywords provided by Michael Thorner, MD, University of Virginia:
ghrelin
growth hormone
aging
normal volunteers

Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs