Trial Outcomes & Findings for The Fasting II Study (NCT NCT01792986)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Water-only 24-hour Fasting Once Per Week for 6 Weeks water-only 24-hour fasting once per week for 6 weeks
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Fasting II Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Water-only 24-hour Fasting Once Per Week for 6 Weeks n=12 Participants
Age, Continuous	58.4 years STANDARD_DEVIATION 7.0 • n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Water-only 24-hour Fasting Once Per Week for 6 Weeks n=12 Participants
Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week. Baseline	104.7 mg/dL Standard Deviation 17.7
Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week. 6-week	104.5 mg/dL Standard Deviation 18.8

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Water-only 24-hour Fasting Once Per Week for 6 Weeks n=12 Participants
Difference in Weight Between Baseline and the End of the Sixth Week 6-week	90.9 kg Standard Deviation 11.1
Difference in Weight Between Baseline and the End of the Sixth Week Baseline	92.5 kg Standard Deviation 11.3

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Water-only 24-hour Fasting Once Per Week for 6 Weeks n=12 Participants
Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week. Baseline	100.9 mg/dL Standard Deviation 38.1
Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week. 6-week	87.8 mg/dL Standard Deviation 27.4

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Water-only 24-hour Fasting Once Per Week for 6 Weeks n=12 Participants
Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week. Baseline	0.69 ng/mL Standard Deviation 1.04
Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week. 6-week	0.51 ng/mL Standard Deviation 0.53

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Water-only 24-hour Fasting Once Per Week for 6 Weeks n=12 Participants
Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week. Baseline	4.82 trillion cells/L Standard Deviation 0.34
Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week. 6-week	4.78 trillion cells/L Standard Deviation 0.35

Adverse Events

Water-only 24-hour Fasting Once Per Week for 6 Weeks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benjamin D. Horne

Intermountain Heart Institute

Phone: 8015074708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place