RECRUITING

The Metabolic Effects of Intermittent Fasting

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Caloric restriction has beneficial metabolic effects in humans including weight loss and improvement in blood pressure and lipid levels. Intermittent fasting has emerged as a popular alternative to caloric restriction as it does not require daily adherence to a dietary protocol, but whether the benefits of fasting protocols are dependent on weight loss is not known. In this study, the investigators will explore the metabolic effects of fasting and evaluate whether these effects, including negative effects on bone metabolism, are independent of weight loss.

Official Title

The Effects of Fasting on Reprogramming of Lipid Metabolism and Bone Metabolism

Quick Facts

Study Start:2023-10-25
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05722873

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.

Ages Eligible for Study:25 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Men and women, ages 25-45 years
  2. 2. BMI of at least 21 kg/m2 and up to and including BMI of 29 kg/m2
  3. 3. Normal thyroid function
  4. 4. Regular menses (women)
  5. 5. At least one first-degree relative with type 2 diabetes (T2D) and/or history of gestational diabetes
  1. 1. Any chronic diseases including hypertension and Type 2 diabetes mellitus
  2. 2. Indication for lipid-lowering therapy in non-diabetics, using the more stringent AHA guideline cutoff (LDL\>190 or an estimated 10-year ASCVD risk of \>7.5%)
  3. 3. Chronic medications, including oral contraceptive pills
  4. 4. Pregnant and/or breastfeeding
  5. 5. History of an eating disorder
  6. 6. 25-OH vitamin D level \< 20 ng/mL
  7. 7. Active substance abuse, including alcohol
  8. 8. Subjects with a prior history of intermittent fasting
  9. 9. The study physician feels that the subject may not be able to safely complete the protocol or may place themselves at risk by undergoing the protocol

Contacts and Locations

Study Contact

Pouneh Fazeli, MD
CONTACT
412-648-9770
pkfazeli@pitt.edu

Principal Investigator

Pouneh Fazeli, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Pouneh Fazeli, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Registration Dates

Study Start Date2023-10-25
Study Completion Date2028-06

Study Record Updates

Study Start Date2023-10-25
Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

  • Normal and Overweight Individuals At High-risk of Diabetes