Effects of Fast Bar on Intermittent Fasting

NCT ID: NCT04790552

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-08-14

Brief Summary

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.

Detailed Description

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.

Conditions

Fasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dinner

Intervention Type: OTHER

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

Fasting

Intervention Type: OTHER

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

Night Bar Group

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.

Group Type: EXPERIMENTAL

Dinner

Intervention Type: OTHER

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

Fasting

Intervention Type: OTHER

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

Fast Bar

Intervention Type: OTHER

Subjects will be asked to consume a Fast Bar.

Bar + Coffee 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 with coffee on day 2.

Group Type: EXPERIMENTAL

Dinner

Intervention Type: OTHER

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

Fasting

Intervention Type: OTHER

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

Bar with Coffee

Intervention Type: OTHER

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

Bar + Tea 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 with tea on day 2.

Group Type: EXPERIMENTAL

Dinner

Intervention Type: OTHER

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

Fasting

Intervention Type: OTHER

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

Bar with Tea

Intervention Type: OTHER

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

Interventions

Dinner

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

Intervention Type: OTHER

Fasting

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

Intervention Type: OTHER

Fast Bar

Subjects will be asked to consume a Fast Bar.

Intervention Type: OTHER

Bar with Coffee

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

Intervention Type: OTHER

Bar with Tea

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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

L-Nutra Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

L-Nutra Inc

Locations

L-Nutra Inc.

Los Angeles, California, United States

Countries

United States

Other Identifiers

20210458

Identifier Type: OTHER

Identifier Source: secondary_id

LN002

Identifier Type: -

Identifier Source: org_study_id