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| ID | Type | Description | Link |
|---|---|---|---|
| 20210458 | Other Identifier | WIRB |
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This study evaluates how Fast Bar(TM), a specially formulated energy bar, when consumed with coffee or tea, affects the physiological condition in participants after an overnight fasting. Participants will fast for 19 hours (Fast Group), consume a Fast Bar in the night (Night Bar Group) or in the morning (Bar+Coffee and Bar+Tea Groups) after an approximately 15-hour overnight fasting. Participants will be assessed for physiological parameters associated with fasting.
Interest in fasting-based programs (i.e. intermittent fasting) for improvement of health and longevity continues to grow. 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 Barâ„¢, which stems out of the well-researched fasting-mimicking diet to assist prolonged fasting. The unique formulation of the Fast Barâ„¢ is hypothesized to minimize deviations in metabolic biomarkers associated with a fasting state. This may ease the burdens associated with extended period of fasting. The objective of this study is to evaluate the metabolic and subjective effects of Fast Bar, when consumed with coffee or tea, after a prolonged period of fasting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast Group | Active Comparator | 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. |
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| Night Bar Group | Experimental | Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will consume a Fast Bar 3 hours after the dinner and then fast overnight. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar with coffee on day 2. |
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| Bar + Coffee Group | Experimental | 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 with coffee on day 2. |
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| Bar + Tea Group | Experimental | 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 with tea on day 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinner | Other | Study subjects will consume a standardized ready-to-eat meal as dinner. |
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| Measure | Description | Time Frame |
|---|---|---|
| Ketone level | Blood ketone (ß-hydroxybutyrate, BHB) level (mg/dL) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Kit. | 3 hours after consuming the study foods (Fast Bar with coffee or tea) |
| 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 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 |
| 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Food evaluation | Food Evaluation Questionnaire will be used to assess the subjective evaluation of the study foods. Evaluation will be performed on a Likert Scale from 1 to 7. | 1 hour after consuming the study foods |
| Self-evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Hsu, MD | L-Nutra Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L-Nutra Inc. | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062407 | Meals |
| C407088 | Angptl4 protein, mouse |
| D017983 | Receptors, Catecholamine |
| D003069 | Coffee |
| D013662 | Tea |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Fasting | Other | Subjects will be asked to fast overnight for approximately 15 hours. |
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| Fast Bar | Other | Subjects will be asked to consume a Fast Bar. |
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| Bar with Coffee | Other | Subjects will be asked to consume a Fast Bar with coffee. |
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| Bar with Tea | Other | Subjects will be asked to consume a Fast Bar with tea. |
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Self-evaluation Questionnaire will be used to assess the huger and other side-effects associated with a 15-hour overnight fasting. Evaluation will be performed on a Likert Scale from 1 to 7.
| 1 hour after consuming the study foods |
| D017982 |
| Receptors, Biogenic Amine |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D043562 | Receptors, G-Protein-Coupled |
| D017981 | Receptors, Neurotransmitter |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |