Fasting Clinical Trial
— FastBarOfficial title:
Randomized, Single-blinded, Controlled, Parallel-arm Study to Evaluate the Effect of Fast Bar(TM) on Physiological Fasting Condition
Verified date | April 2024 |
Source | L-Nutra Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates how Fast Bar(TM), a specially formulated energy bar, affects the physiological condition in participants after an overnight fasting. Participants will fast for 19 hours (Fast Group), consume a breakfast Bar (Breakfast Group) or a Fast Bar(TM) (Fast Bar Group) after an approximately 15-hour overnight fasting. Participants will be assessed for physiological parameters associated with fasting.
Status | Completed |
Enrollment | 110 |
Est. completion date | September 30, 2020 |
Est. primary completion date | September 28, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Ability and willingness to provide written informed consent; - Ability and willingness to use Zoom teleconference; - Ability and willingness to perform the study tests and adhere to study protocol (to the best of the participant's knowledge); - BMI 20-35 kg/m2 (inclusive) at screening; - In good health (as determined by medical history to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days). Exclusion Criteria: - Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation* (*Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial); - History of gastric bypass (based on medical history provided at screening); - Under medications aimed at keeping blood glucose under control (based on medical history provided at screening); - Type 1 diabetes (based on medical history provided at screening); - Taking insulin, insulin analogs, or octreotide (based on medical history provided at screening); - Food allergies which would make the subject unable to consume the food provided (based on medical history and information provided at screening) (participants will be asked to review the ingredient lists for the dinner meal, the breakfast and the Fast Bar, and to state that they are not allergic to the ingredients to the best of their knowledge); - Women who are pregnant; - Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men) (based on medical history and information provided at screening). |
Country | Name | City | State |
---|---|---|---|
United States | L-Nutra Inc. | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
L-Nutra Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ketone Area Under the Curve | Blood ketone (ß-hydroxybutyrate, BHB) area under the curve (AUC) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Meter Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods. | BHB Area Under the Curve between 0 to 4 hours after consuming the study foods | |
Primary | Glucose Area Under the Curve | Blood glucose area under the curve (AUC) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Meter Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods. | Glucose Area Under the Curve between 0 to 4 hours after consuming the study foods |
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