L-Nutra Inc.
Los Angeles, California, 90048, United States
NCT Number: NCT04790552
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.
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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. 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 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.
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 will be asked to fast overnight for approximately 15 hours.
Subjects will be asked to consume a Fast Bar.
Subjects will be asked to consume a Fast Bar with coffee.
Subjects will be asked to consume a Fast Bar with tea.
Time frame: 3 hours after consuming the study foods (Fast Bar with coffee or tea)
Blood ketone (ß-hydroxybutyrate, BHB) level (mg/dL) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Kit.
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 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 Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods
Time frame: 1 hour after consuming the study foods
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.
Time frame: 1 hour after consuming the study foods
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.
L-Nutra Inc
Industry
The Effects of Fast Bar on Facilitating Prolonged Fasting - a Randomized, Controlled, Parallel-arm Study
Acronym: FastBar2
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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