Back to resultsThe Metabolic Effects of Intermittent Fasting
Primary Purpose
Normal and Overweight Individuals at High-risk of Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fasting arm
Weight maintenance
Counseling
Sponsored by
About this trial
This is an interventional prevention trial for Normal and Overweight Individuals at High-risk of Diabetes
Eligibility Criteria
Inclusion Criteria: Men and women, ages 25-45 years BMI of at least 21 kg/m2 and up to and including BMI of 29 kg/m2 Normal thyroid function Regular menses (women) At least one first-degree relative with type 2 diabetes (T2D) and/or history of gestational diabetes Exclusion Criteria: Any chronic diseases including hypertension and Type 2 diabetes mellitus 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%) Chronic medications, including oral contraceptive pills Pregnant and/or breastfeeding History of an eating disorder 25-OH vitamin D level < 20 ng/mL Active substance abuse, including alcohol Subjects with a prior history of intermittent fasting 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
Sites / Locations
- University of PittsburghRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Fasting
Fasting with weight maintenance
Counseling
Arm Description
Subjects will fast one-day per week for 12 weeks
Subjects will fast one-day per week for 12 weeks and maintain body weight
Subjects will be counseled on optimal diet and activity recommendations to maintain/achieve a normal BMI (standard of care)
Outcomes
Primary Outcome Measures
Triglyceride carbon content and degree of saturation
Change in triglyceride carbon content and degree of saturation (% variation explained by both carbon number and double bond number in a regression model) between Baseline and Final Intervention visits
Trabecular bone microarchitecture
Change in trabecular bone volume fraction at the radius between Baseline and Final Intervention visits
Secondary Outcome Measures
Insulin sensitivity
Change in insulin sensitivity as assessed by hyperinsulinemic-euglycemic clamp between Baseline and Final Intervention visits
Full Information
NCT ID
NCT05722873
First Posted
January 27, 2023
Last Updated
October 4, 2023
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT05722873
Brief Title
The Metabolic Effects of Intermittent Fasting
Official Title
The Effects of Fasting on Reprogramming of Lipid Metabolism and Bone Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
June 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal and Overweight Individuals at High-risk of Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fasting
Arm Type
Experimental
Arm Description
Subjects will fast one-day per week for 12 weeks
Arm Title
Fasting with weight maintenance
Arm Type
Experimental
Arm Description
Subjects will fast one-day per week for 12 weeks and maintain body weight
Arm Title
Counseling
Arm Type
Placebo Comparator
Arm Description
Subjects will be counseled on optimal diet and activity recommendations to maintain/achieve a normal BMI (standard of care)
Intervention Type
Behavioral
Intervention Name(s)
Fasting arm
Intervention Description
Study participants will fast one day per week for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Weight maintenance
Intervention Description
Study participants will be counseled to maintain body weight
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
Study participants will be counseled on optimal diet and activity recommendations for maintaining/achieving a normal BMI
Primary Outcome Measure Information:
Title
Triglyceride carbon content and degree of saturation
Description
Change in triglyceride carbon content and degree of saturation (% variation explained by both carbon number and double bond number in a regression model) between Baseline and Final Intervention visits
Time Frame
Baseline, 3 months
Title
Trabecular bone microarchitecture
Description
Change in trabecular bone volume fraction at the radius between Baseline and Final Intervention visits
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Insulin sensitivity
Description
Change in insulin sensitivity as assessed by hyperinsulinemic-euglycemic clamp between Baseline and Final Intervention visits
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women, ages 25-45 years
BMI of at least 21 kg/m2 and up to and including BMI of 29 kg/m2
Normal thyroid function
Regular menses (women)
At least one first-degree relative with type 2 diabetes (T2D) and/or history of gestational diabetes
Exclusion Criteria:
Any chronic diseases including hypertension and Type 2 diabetes mellitus
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%)
Chronic medications, including oral contraceptive pills
Pregnant and/or breastfeeding
History of an eating disorder
25-OH vitamin D level < 20 ng/mL
Active substance abuse, including alcohol
Subjects with a prior history of intermittent fasting
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pouneh Fazeli, MD
Phone
412-648-9770
Email
pkfazeli@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pouneh Fazeli, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pouneh Fazeli, MD
Email
pkfazeli@pitt.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified information will be shared upon request.
IPD Sharing Time Frame
Beginning 12 months after publication. No end date.
IPD Sharing Access Criteria
Researchers who wish to access deidentified data.
Learn more about this trial
The Metabolic Effects of Intermittent Fasting
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