L-Nutra Inc.
Los Angeles, California, 90048, United States
NCT Number: NCT04499599
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90048, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study subjects will consume a standardized ready-to-eat meal as dinner.
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 subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).
Time frame: 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.
Time frame: 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.
L-Nutra Inc
Industry
Randomized, Single-blinded, Controlled, Parallel-arm Study to Evaluate the Effect of Fast Bar(TM) on Physiological Fasting Condition
Acronym: FastBar
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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