FastingFastBar2NCT04790552

Effects of Fast Bar on Intermittent Fasting

A study testing Dinner, Fasting and Fast Bar in people with Fasting, run by L-Nutra Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Fasting
What is being tested?: Dinner, Fasting and Fast Bar
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2021to 14 Aug 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

L-Nutra Inc.
Los Angeles, California, 90048

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: Dinner, Fasting, Fast Bar, Bar with Coffee, Bar with Tea
Keywords: Fast Bar, Intermittent fasting, Ketone bodies, ß-hydroxybutyrate
Medical subject headings: Fasting, Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DinnerOther
Study subjects will consume a standardized ready-to-eat meal as dinner.
FastingOther
Subjects will be asked to fast overnight for approximately 15 hours.
Fast BarOther
Subjects will be asked to consume a Fast Bar.
Bar with CoffeeOther
Subjects will be asked to consume a Fast Bar with coffee.
Bar with TeaOther
Subjects will be asked to consume a Fast Bar with tea.

Study groups in NCT04790552
Study group	Role	What they receive
Fast Group	Active comparator	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. Receives: Other: Dinner; Other: Fasting
Night Bar Group	Experimental	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. Receives: Other: Dinner; Other: Fasting; Other: Fast Bar
Bar + Coffee Group	Experimental	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. Receives: Other: Dinner; Other: Fasting; Other: Bar with Coffee
Bar + Tea Group	Experimental	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. Receives: Other: Dinner; Other: Fasting; Other: Bar with Tea

What is being measured

The primary outcome is the main question the study is designed to answer.

Ketone level
Blood ketone (ß-hydroxybutyrate, BHB) level (mg/dL) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Kit.
Measured: 3 hours after consuming the study foods (Fast Bar with coffee or tea)
Ketone Area Under the Curve
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.
Measured: BHB Area Under the Curve between 0 to 4 hours after consuming the study foods
Glucose Area Under the Curve
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
Measured: Glucose Area Under the Curve between 0 to 4 hours after consuming the study foods

Secondary outcomes (2)

Food evaluation
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.
Measured: 1 hour after consuming the study foods
Self-evaluation
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.
Measured: 1 hour after consuming the study foods

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202114 Aug 2021

First posted10 Mar 2021
Study start1 Mar 2021
Primary completion1 Aug 2021
Study completion14 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for FastingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04790552
Sponsor's protocol ID: LN002
Other IDs: 20210458
Acronym: FastBar2
Status last verified: Sep 2021
First submitted: 6 Mar 2021
Last updated: 9 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Fast Bar on Facilitating Prolonged Fasting - a Randomized, Controlled, Parallel-arm Study
ClinicalTrials.gov ID: NCT04790552
Acronym / sponsor ID: FastBar2 / LN002
Conditions: Fasting
Keywords: Fast Bar, Intermittent fasting, Ketone bodies, ß-hydroxybutyrate
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: L-Nutra IncIndustry (pharma, biotech, devices)
Study start: 1 Mar 2021 (actual)
Primary completion: 1 Aug 2021 (actual)
Study completion: 14 Aug 2021 (actual)
First posted: 10 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Fast Group	Active comparator	Other: Dinner, Other: FastingSubjects 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.
Night Bar Group	Experimental	Other: Dinner, Other: Fasting, Other: Fast BarSubjects 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.
Bar + Coffee Group	Experimental	Other: Dinner, Other: Fasting, Other: Bar with CoffeeSubjects 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.
Bar + Tea Group	Experimental	Other: Dinner, Other: Fasting, Other: Bar with TeaSubjects 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (8 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DinnerStudy subjects will consume a standardized ready-to-eat meal as dinner.	Other	Bar + Coffee Group, Bar + Tea Group, Fast Group, Night Bar Group
FastingSubjects will be asked to fast overnight for approximately 15 hours.	Other	Bar + Coffee Group, Bar + Tea Group, Fast Group, Night Bar Group
Fast BarSubjects will be asked to consume a Fast Bar.	Other	Night Bar Group
Bar with CoffeeSubjects will be asked to consume a Fast Bar with coffee.	Other	Bar + Coffee Group
Bar with TeaSubjects will be asked to consume a Fast Bar with tea.	Other	Bar + Tea Group

Primary outcome

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.
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.
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

2 secondary outcomes

Food evaluation
Time frame: 1 hour after consuming the study foods
Self-evaluation
Time frame: 1 hour after consuming the study foods

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Hsu, MD principal investigator

L-Nutra Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dinner, Fasting and Fast Bar in people with Fasting, run by L-Nutra Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ketone level (time frame: 3 hours after consuming the study foods (Fast Bar with coffee or tea)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04790552.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.