FastBar: Effects of Fast Bar on Physiological Fasting

• Sponsor: L-Nutra Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04499599
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 3
• Actual Duration (Months): 2.4
• Patients Per Site Per Month: 46.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Fasting	Other: Dinner; Other: Fasting; Other: Study food	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: For comparison between the placebo breakfast bar and the Fast Bar groups, the participants are masked.
• Primary Purpose: Supportive Care
• Official Title: Randomized, Single-blinded, Controlled, Parallel-arm Study to Evaluate the Effect of Fast Bar(TM) on Physiological Fasting Condition
• Actual Study Start Date: Jul 20, 2020
• Actual Primary Completion Date: Sep 28, 2020
• Actual Study Completion Date: Sep 30, 2020

Arms and Interventions

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 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.
Placebo Comparator: Breakfast 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 breakfast bar on day 2.	Other: Dinner; Study subjects will consume a standardized ready-to-eat meal as dinner.; Other: Fasting; 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.; Other: Study food; 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).
Experimental: Fast Bar 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 on day 2.	Other: Dinner; Study subjects will consume a standardized ready-to-eat meal as dinner.; Other: Fasting; 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.; Other: Study food; 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).

Outcome Measures

Primary Outcome Measures

1. Ketone Area Under the Curve [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.

2. Glucose Area Under the Curve [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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);

• 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).

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, the breakfast and the Fast Bar, 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	L-Nutra Inc.	Los Angeles	California	United States	90048

Sponsors and Collaborators

• L-Nutra Inc

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 19, 2020
• Informed Consent Form - Jul 13, 2020

More Information

Publications

None provided.

• Responsible Party: L-Nutra Inc
• ClinicalTrials.gov Identifier: NCT04499599
• Other Study ID Numbers: 20201920
• First Posted: Aug 5, 2020
• Last Update Posted: Oct 4, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by L-Nutra Inc: Fast Bar; Fasting; Intermittent fasting; Ketone bodies; ß-hydroxybutyrate

Study Results

Participant Flow

Arm/Group Title	Fast Group	Breakfast Group	Fast Bar Group
Arm/Group Description	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. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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.	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 breakfast bar on day 2. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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 food: 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).	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 on day 2. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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 food: 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).
Period Title: Overall Study
STARTED	35	35	35
COMPLETED	35	35	35
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Fast Group	Breakfast Group	Fast Bar Group	Total
Arm/Group Description	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. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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.	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 breakfast bar on day 2. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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 food: 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).	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 on day 2. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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 food: 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).	Total of all reporting groups
Overall Participants	35	35	35	105
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (11.5)	45.9 (12.5)	46.4 (10.9)	46.1 (11.6)
Sex: Female, Male (Count of Participants)
Female	27 77.1%	22 62.9%	23 65.7%	72 68.6%
Male	8 22.9%	13 37.1%	12 34.3%	33 31.4%
Race/Ethnicity, Customized (Count of Participants)
White	25 71.4%	27 77.1%	30 85.7%	82 78.1%
Black	2 5.7%	3 8.6%	1 2.9%	6 5.7%
Hispanic	7 20%	2 5.7%	3 8.6%	12 11.4%
Asian	1 2.9%	3 8.6%	1 2.9%	5 4.8%

Outcome Measures

1. Primary Outcome

Title	Ketone Area Under the Curve
Description	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	BHB Area Under the Curve between 0 to 4 hours after consuming the study foods

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fast Group	Breakfast Group	Fast Bar Group
Arm/Group Description	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. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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.	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 breakfast bar on day 2. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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 food: 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).	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 on day 2. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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 food: 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).
Measure Participants	35	35	35
Mean (Standard Deviation) [mg/dL*h]	1.27 (.53)	0.62 (0.18)	1.17 (0.34)

2. Primary Outcome

Title	Glucose Area Under the Curve
Description	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.
Time Frame	Glucose Area Under the Curve between 0 to 4 hours after consuming the study foods

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fast Group	Breakfast Group	Fast Bar Group
Arm/Group Description	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. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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.	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 breakfast bar on day 2. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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 food: 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).	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 on day 2. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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 food: 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).
Measure Participants	35	35	35
Mean (Standard Deviation) [mg/dL*h]	365 (50)	401.4 (42.3)	363.5 (37.3)

Adverse Events

Time Frame	2 days.
Arm/Group Title	Fast Group		Breakfast Group		Fast Bar Group
Arm/Group Description	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. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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.		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 breakfast bar on day 2. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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 food: 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).		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 on day 2. Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner. Fasting: 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 food: 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).
All Cause Mortality
	Fast Group		Breakfast Group		Fast Bar Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)		0/35 (0%)
Serious Adverse Events
	Fast Group		Breakfast Group		Fast Bar Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Fast Group		Breakfast Group		Fast Bar Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)		0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.