Fasting
Conditions
Keywords
Fast Bar, Fasting, Intermittent fasting, Ketone bodies, ß-hydroxybutyrate
Brief 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.
Detailed description
Interest in fasting-based programs (i.e. intermittent fasting) for improvement of health and longevity continues to grow. While benefits of intermittent fasting have been convincingly demonstrated in rodent models, the more limited data in humans is less clear. The short-term fasting (e.g. 12 to 48 hours in duration) utilized in many intermittent fasting programs are considered safe, but some individuals may find them subjectively difficult. As such, the question of whether the benefits of fasting can be obtained while small amounts of food are consumed is of substantial interest. One commercially available product that is designed to be consumed during periods of intermittent fasting is the Fast Bar™,which stems out of the well-researched fasting-mimicking diet to assist prolonged fasting. The unique formulation of the Fast Bar™ is hypothesized to minimize deviations in metabolic biomarkers associated with a fasting state. This may allow for extension of a fasting period through reduced subjective difficulty of fasting.The objective of this study is to evaluate the metabolic and subjective effects of consuming a novel food product (Fast Bar™) after a short period of fasting.
Interventions
OTHERDinner
Study subjects will consume a standardized ready-to-eat meal as dinner.
OTHERFasting
Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.
OTHERStudy food
Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).
Sponsors
L-Nutra Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
For comparison between the placebo breakfast bar and the Fast Bar groups, the participants are masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ketone Area Under the Curve | BHB Area Under the Curve between 0 to 4 hours after consuming the study foods | 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. |
| Glucose Area Under the Curve | Glucose Area Under the Curve between 0 to 4 hours after consuming the study foods | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fast Group Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 19 hours.
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours. | 35 |
| Breakfast Group Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a breakfast bar on day 2.
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.
Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group). | 35 |
| Fast Bar Group Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar on day 2.
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.
Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group). | 35 |
| Total | 105 |
Baseline characteristics
| Characteristic | Fast Group | Breakfast Group | Fast Bar Group | Total |
|---|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 11.5 | 45.9 years STANDARD_DEVIATION 12.5 | 46.4 years STANDARD_DEVIATION 10.9 | 46.1 years STANDARD_DEVIATION 11.6 |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants | 2 Participants | 3 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 25 Participants | 27 Participants | 30 Participants | 82 Participants |
| Sex: Female, Male Female | 27 Participants | 22 Participants | 23 Participants | 72 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 12 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 | 0 / 35 |
Outcome results
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.
Time frame: Glucose Area Under the Curve between 0 to 4 hours after consuming the study foods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fast Group | Glucose Area Under the Curve | 365 mg/dL*h | Standard Deviation 50 |
| Breakfast Group | Glucose Area Under the Curve | 401.4 mg/dL*h | Standard Deviation 42.3 |
| Fast Bar Group | Glucose Area Under the Curve | 363.5 mg/dL*h | Standard Deviation 37.3 |
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.
Time frame: BHB Area Under the Curve between 0 to 4 hours after consuming the study foods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fast Group | Ketone Area Under the Curve | 1.27 mg/dL*h | Standard Deviation 0.53 |
| Breakfast Group | Ketone Area Under the Curve | 0.62 mg/dL*h | Standard Deviation 0.18 |
| Fast Bar Group | Ketone Area Under the Curve | 1.17 mg/dL*h | Standard Deviation 0.34 |