Effects of Fast Bar on Intermittent Fasting (FastBar2)

September 4, 2021 updated by: L-Nutra Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • L-Nutra Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Dinner
Study subjects will consume a standardized ready-to-eat meal as dinner.
Other: Fasting
Subjects will be asked to fast overnight for approximately 15 hours.
Experimental: 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.
Other: Dinner
Study subjects will consume a standardized ready-to-eat meal as dinner.
Other: Fasting
Subjects will be asked to fast overnight for approximately 15 hours.
Other: Fast Bar
Subjects will be asked to consume a Fast Bar.
Experimental: 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.
Other: Dinner
Study subjects will consume a standardized ready-to-eat meal as dinner.
Other: Fasting
Subjects will be asked to fast overnight for approximately 15 hours.
Other: Bar with Coffee
Subjects will be asked to consume a Fast Bar with coffee.
Experimental: 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.
Other: Dinner
Study subjects will consume a standardized ready-to-eat meal as dinner.
Other: Fasting
Subjects will be asked to fast overnight for approximately 15 hours.
Other: Bar with Tea
Subjects will be asked to consume a Fast Bar with tea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 hours after consuming the study foods (Fast Bar with coffee or tea)
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.
BHB Area Under the Curve between 0 to 4 hours after consuming the study foods
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
Glucose Area Under the Curve between 0 to 4 hours after consuming the study foods

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour after consuming the study foods
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.
1 hour after consuming the study foods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

L-Nutra Inc

Investigators

  • Principal Investigator: William Hsu, MD, L-Nutra Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 14, 2021

Study Registration Dates

First Submitted

March 6, 2021

First Submitted That Met QC Criteria

March 6, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 4, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LN002
  • 20210458 (Other Identifier: WIRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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