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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922973
• Other study ID #: 10619
• Status: Completed
• Phase: N/A
• First received: August 12, 2013
• Last updated: August 12, 2013
• Start date: May 2003
• Est. completion date: December 2004

Study information

• Verified date: August 2013
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Aging

Intervention

Other:
• Fasting
normal volunteers fast from food on one occasion for 62.5 h; on another occasion fed 3 meals

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ghrelin concentration		24-h mean	No