Effects of Fast Bar on Physiological Fasting

NCT04499599 | Completed Results

• 1 other identifier: 20201920
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasting

Keywords

Fast Bar; Fasting; Intermittent fasting; Ketone bodies; ß-hydroxybutyrate

Outcome Measures

Primary Outcomes (2)

• 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 Meter 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 Meter 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

Study Arms (3)

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: Dinner; Other: Fasting

Breakfast Group

PLACEBO 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 15 hours and then consume a breakfast bar on day 2.

Other: Dinner; Other: Fasting; Other: Study food

Fast Bar 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 on day 2.

Other: Dinner; Other: Fasting; Other: Study food

Interventions

Dinner OTHER

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

Breakfast Group; Fast Bar Group; Fast Group

Fasting OTHER

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.

Breakfast Group; Fast Bar Group; Fast Group

Study food OTHER

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).

Breakfast Group; Fast Bar Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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);
• 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).

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, 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).

Sponsors & Collaborators

• L-Nutra Inc: lead

Study Sites (1)

L-Nutra Inc.

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Fasting; Intermittent Fasting

Interventions

Meals; Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Min Wei
• Organization: L-Nutra, Inc.

mwei@l-nutra.com

323.791.2426

Study Officials

• William C Hsu, MD

  L-Nutra Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: For comparison between the placebo breakfast bar and the Fast Bar groups, the participants are masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 5, 2020
• Study Start: July 20, 2020
• Primary Completion: September 28, 2020
• Study Completion: September 30, 2020
• Last Updated: April 9, 2024
• Results First Posted: October 4, 2021

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)