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Expression of Longevity Genes in Response to Extended Fasting (FEELGOOD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01059760
First received: January 28, 2010
Last updated: April 18, 2017
Last verified: March 2011
Results First Received: December 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cardiovascular Disease
Interventions: Behavioral: Fasting First
Behavioral: Fed First

  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
Fasting Day First 28±4 hours of water-only fasting followed by 28±4 hours fed
Fed Day First 28± 4 hours fed followed by 28± 4 hours of fasting

Participant Flow:   Overall Study
    Fasting Day First   Fed Day First
STARTED   16   14 
COMPLETED   16   14 
NOT COMPLETED   0   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
Fasting Day First 28±4 hours of water-only fasting followed by 28±4 hours fed
Fed Day First 28± 4 hours fed followed by 28± 4 hours of fasting
Total Total of all reporting groups

Baseline Measures
   Fasting Day First   Fed Day First   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   14   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.3  (13.6)   44.0  (14.0)   43.6  (13.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  68.8%      9  64.3%      20  66.7% 
Male      5  31.3%      5  35.7%      10  33.3% 
Region of Enrollment 
[Units: Participants]
     
United States   16   14   30 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 28.4  (7.1)   27.3  (6.1)   27.8  (1.3) 
Hemoglobin A1C 
[Units: Percentage]
Mean (Standard Deviation)
 5.5  (0.3)   5.3  (0.3)   5.4  (0.3) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Participant Glucose When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

2.  Primary:   Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

3.  Primary:   Change From Baseline in Participant Insulin When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

4.  Primary:   Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

5.  Primary:   Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

6.  Primary:   Change From Baseline in Participant Adiponectin When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

7.  Primary:   Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

8.  Primary:   Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

9.  Primary:   Change From Baseline in Participant Hemoglobin When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

10.  Primary:   Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

11.  Primary:   Change From Baseline in Participant Hematocrit When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

12.  Primary:   Change From Baseline in Participant Platelet Count When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

13.  Primary:   Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

14.  Primary:   Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

15.  Primary:   Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

16.  Primary:   Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

17.  Primary:   Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

18.  Primary:   Change From Baseline in Participant Bicarbonate When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

19.  Primary:   Change From Baseline in Participant Sodium When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

20.  Primary:   Change From Baseline in Participant Chloride When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

21.  Primary:   Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

22.  Primary:   Change From Baseline in Participant Calcium When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

23.  Primary:   Change From Baseline in Participant Potassium When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

24.  Primary:   Change From Baseline in Participant Creatinine When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

25.  Primary:   Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

26.  Primary:   Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

27.  Primary:   Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

28.  Primary:   Change From Baseline in Participant Triglycerides When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

29.  Primary:   Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

30.  Primary:   Change From Baseline in Participant Weight When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

31.  Primary:   Change From Baseline in Participant Waist Circumference When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

32.  Primary:   Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

33.  Primary:   Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed   [ Time Frame: Baseline and 3 days ]

34.  Primary:   Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed   [ Time Frame: Baseline and 3 days ]


  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


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01059760     History of Changes
Other Study ID Numbers: 154-002
Study First Received: January 28, 2010
Results First Received: December 21, 2016
Last Updated: April 18, 2017