Trial Outcomes & Findings for Effects of Fast Bar on Physiological Fasting (NCT NCT04499599)
NCT ID: NCT04499599
Last Updated: 2024-04-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
BHB Area Under the Curve between 0 to 4 hours after consuming the study foods
Results posted on
2024-04-09
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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).
|
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).
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Fast Bar on Physiological Fasting
Baseline characteristics by cohort
| Measure |
Fast Group
n=35 Participants
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.
|
Breakfast Group
n=35 Participants
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).
|
Fast Bar Group
n=35 Participants
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
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BHB Area Under the Curve between 0 to 4 hours after consuming the study foodsBlood 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.
Outcome measures
| Measure |
Fast Group
n=35 Participants
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.
|
Breakfast Group
n=35 Participants
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).
|
Fast Bar Group
n=35 Participants
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).
|
|---|---|---|---|
|
Ketone Area Under the Curve
|
1.27 mg/dL*h
Standard Deviation 0.53
|
0.62 mg/dL*h
Standard Deviation 0.18
|
1.17 mg/dL*h
Standard Deviation 0.34
|
PRIMARY outcome
Timeframe: Glucose Area Under the Curve between 0 to 4 hours after consuming the study foodsBlood 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.
Outcome measures
| Measure |
Fast Group
n=35 Participants
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.
|
Breakfast Group
n=35 Participants
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).
|
Fast Bar Group
n=35 Participants
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).
|
|---|---|---|---|
|
Glucose Area Under the Curve
|
365 mg/dL*h
Standard Deviation 50
|
401.4 mg/dL*h
Standard Deviation 42.3
|
363.5 mg/dL*h
Standard Deviation 37.3
|
Adverse Events
Fast Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Breakfast Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fast Bar Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place