N/A
N=105
Effects of Fast Bar on Physiological Fasting
Fasting
Bottom Line
View on ClinicalTrials.gov: NCT04499599 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Ketone Area Under the Curve — 1.27; 0.62; 1.17 mg/dL*h
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dinner (Other); Fasting (Other); Study food (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- L-Nutra Inc
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ketone Area Under the Curve |
1.27; 0.62; 1.17 | — |
| PRIMARY Glucose Area Under the Curve |
365; 401.4; 363.5 | — |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04499599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.