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

NCT ID: NCT01792986

Last Updated: 2017-03-20

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

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

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=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants

PRIMARY outcome

Timeframe: 6 weeks

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

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 Baseline	92.5 kg Standard Deviation 11.3
Difference in Weight Between Baseline and the End of the Sixth Week 6-week	90.9 kg Standard Deviation 11.1

SECONDARY outcome

Timeframe: 6 weeks

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

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

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: benjamin.horne@imail.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place