Clinical Trials Directory

Trials / Terminated

TerminatedNCT03938441

Biweekly Interval Intermittent Fasting for Type 2 Diabetes, a Safety Study

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
gino gaddini · Federal
Sex
All
Age
18 Years – 69 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to establish safety of biweekly intermittent fasting in the setting of type 2 diabetes mellitus or prediabetes under treatment with non-hypoglycemic agents (e.g. metformin).

Detailed description

This study is proposed as a prospective interventional cohort safety study for biweekly intermittent fasting. In the effort to improve compliance of lifetime dietary change, the version of 5:2 intermittent fasting to be applied in this study will be somewhat less intensive than implemented then what has been proposed in some recent, similar studies. On fasting days, instead of limiting the subject to a specific calorie count, the subject will be instead instructed to skip either the first or last meal of the day in order to complete a 12 to 16 hour fast, during which time they are allowed drink water or any non-caloric beverage of their choice, but not consume any calories. Furthermore, the patient will be instructed for their remaining 2 meals to consume no more than they would on a normal, non-fasting day.

Conditions

Interventions

TypeNameDescription
OTHERIntermittent FastingThe version of 5:2 intermittent fasting to be applied in this study will be somewhat less intensive than implemented then what has been proposed in some recent, similar studies. On fasting days, instead of limiting the subject to a specific calorie count, the subject will be instead instructed to skip either the first or last meal of the day in order to complete a 12 to 16 hour fast, during which time they are allowed drink water or any non-caloric beverage of their choice, but not consume any calories. Furthermore, the patient will be instructed for their remaining 2 meals to consume no more than they would on a normal, non-fasting day.

Timeline

Start date
2019-07-31
Primary completion
2021-05-28
Completion
2021-05-28
First posted
2019-05-06
Last updated
2021-06-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03938441. Inclusion in this directory is not an endorsement.