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The Fasting II Study

This study has been completed.
Sponsor:
Collaborator:
Intermountain Research and Medical Foundation
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01792986
First received: February 12, 2013
Last updated: February 10, 2017
Last verified: July 2013
Results First Received: December 9, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Other
Conditions: Diabetes
Metabolic Diseases
Intervention: Behavioral: water-only 24-hour fasting once per week for 6 weeks

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Water-only 24-hour Fasting Once Per Week for 6 Weeks water-only 24-hour fasting once per week for 6 weeks

Participant Flow:   Overall Study
    Water-only 24-hour Fasting Once Per Week for 6 Weeks
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Water-only 24-hour Fasting Once Per Week for 6 Weeks No text entered.

Baseline Measures
   Water-only 24-hour Fasting Once Per Week for 6 Weeks 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.4  (7.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  75.0% 
Male      3  25.0% 


  Outcome Measures
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1.  Primary:   Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week.   [ Time Frame: 6 weeks ]

2.  Secondary:   Difference in Weight Between Baseline and the End of the Sixth Week   [ Time Frame: 6 weeks ]

3.  Secondary:   Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week.   [ Time Frame: 6 weeks ]

4.  Secondary:   Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week.   [ Time Frame: 6 weeks ]

5.  Secondary:   Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week.   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Benjamin D. Horne
Organization: Intermountain Heart Institute
phone: 8015074708
e-mail: benjamin.horne@imail.org



Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01792986     History of Changes
Other Study ID Numbers: 1024469
Study First Received: February 12, 2013
Results First Received: December 9, 2016
Last Updated: February 10, 2017