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

August 12, 2013 updated by: Michael Thorner, MD, University of Virginia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

21

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

normal volunteers

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ghrelin concentration
Time Frame: 24-h mean
24-h mean

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Michael O Thorner, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Estimate)

August 14, 2013

Last Update Submitted That Met QC Criteria

August 12, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10619

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on Fasting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe