NCT04790552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

March 6, 2021

Last Update Submit

September 4, 2021

Conditions

Fasting

Keywords

Fast BarIntermittent fastingKetone bodiesß-hydroxybutyrate

Outcome Measures

Primary Outcomes (3)

  • Ketone level

    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

    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

    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 Outcomes (2)

  • Food evaluation

    1 hour after consuming the study foods

  • Self-evaluation

    1 hour after consuming the study foods

Study Arms (4)

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.

Other: DinnerOther: 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.

Other: DinnerOther: FastingOther: 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.

Other: DinnerOther: FastingOther: 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.

Other: DinnerOther: FastingOther: Bar with Tea

Interventions

DinnerOTHER

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

Bar + Coffee GroupBar + Tea GroupFast GroupNight Bar Group
FastingOTHER

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

Bar + Coffee GroupBar + Tea GroupFast GroupNight Bar Group
Fast BarOTHER

Subjects will be asked to consume a Fast Bar.

Night Bar Group
Bar with CoffeeOTHER

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

Bar + Coffee Group
Bar with TeaOTHER

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

Bar + Tea Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

L-Nutra Inc.

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

FastingIntermittent Fasting

Interventions

MealsAngptl4 protein, mouseReceptors, CatecholamineCoffeeTea

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesReceptors, Biogenic AmineReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, G-Protein-CoupledReceptors, NeurotransmitterPlant PreparationsBiological ProductsComplex MixturesBeverages

Study Officials

  • William Hsu, MD

    L-Nutra Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2021

First Posted

March 10, 2021

Study Start

March 1, 2021

Primary Completion

August 1, 2021

Study Completion

August 14, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)