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Completed

NCT Number: NCT04790552

Effects of Fast Bar on Intermittent Fasting

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

L-Nutra Inc.

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;
  • 18-65 years of age (inclusive) at screening;
  • 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);
  • Habitual breakfast eater (determined with a screening survey: number of breakfasts per week ≥4.

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 and the Fast BarTM, 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).

Treatment and study plan

Dinner

Other

Study subjects will consume a standardized ready-to-eat meal as dinner.

Fasting

Other

Subjects will be asked to fast overnight for approximately 15 hours.

Fast Bar

Other

Subjects will be asked to consume a Fast Bar.

Bar with Coffee

Other

Subjects will be asked to consume a Fast Bar with coffee.

Bar with Tea

Other

Subjects will be asked to consume a Fast Bar with tea.

Primary outcomes

  1. Ketone level

    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.

  2. Ketone Area Under the Curve

    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.

  3. Glucose Area Under the Curve

    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

Secondary outcomes

  1. Food evaluation

    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.

  2. Self-evaluation

    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.

Sponsors and collaborators

Lead sponsor

L-Nutra Inc

Industry

Registry information

Official study title

The Effects of Fast Bar on Facilitating Prolonged Fasting - a Randomized, Controlled, Parallel-arm Study

Acronym: FastBar2

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2021
Registry last updated
Sep 9, 2021

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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