MedDataX Logo

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

NCT ID: NCT01922973

Last Updated: 2013-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Aging

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ghrelin growth hormone aging normal volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Fasting

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fasting

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Thorner, MD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael O Thorner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10619

Identifier Type: -

Identifier Source: org_study_id