Trial Outcomes & Findings for Comparison of the Postprandial Glycemic and Insulinemic Response After a Fibersym Containing Cookie With a Control (NCT NCT04820322)

Results Overview

2-hour postprandial glucose incremental area under the curve (IAUC), calculated from blood samples taken 5 min prior to meal, 0, 15, 30, 45, 60, 90 and 120 min after the start of the test meal.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

2 hours

Results posted on

2025-01-22

Participant Flow

Eligible participants were randomized to the treatment order on the first visit after screening. None were excluded between screening and the first visit. Ten (n=10) participants were randomized to receive the control cookie first followed by the Fibersym cookie; one participant dropped out after the control cookie due to developing and infection. Six (n=6) participants were randomized to receive the fibersym cookie first followed by the control cookie.

Participant milestones

Participant milestones
Measure	Experimental: Control Cookie, Then Fibersym Cookie Participants consumed 109g of control cookies (about 3.5 cookies - at least 1 cookie at each main meal) daily for 3 days. On the evening of the 3rd day they consumed the frozen dinner they had been provided with. They came to the test center the next morning after an overnight fast when the glucose and insulin responses elicited by 78.1g of control cookie (40g available carbohydrate) were measured. After a 6-28 day washout period participants repeated the process, consuming 136g of Fibersym cookies (about 4 cookies, 29g fiber, at least 1 with each main meal) daily for 3 days, consuming the standard dinner on the 3rd day and after an overnight fasting having glucose and insulin responses elicited by 97.8g Fibersym cookie (40g available carbohydrate) measured.	Fibersym Cookie First Participants consumed 136g of Fibersym cookies (about 4 cookies, 29g fiber, at least 1 cookie at each main meal) daily for 3 days. On the evening of the 3rd day they consumed the frozen dinner they had been provided with. They came to the test center the next morning after an overnight fast when the glucose and insulin responses elicited by 97.8g of Fibersym cookie (40g available carbohydrate) were measured. After a 6-28 day washout period participants repeated the process, consuming 109g of control cookies (about 3.5 cookies, at least 1 with each main meal) daily for 3 days, consuming the standard dinner on the 3rd day and after an overnight fasting having glucose and insulin responses elicited by 78.1g Control cookie (40g available carbohydrate) measured.
Overall Study STARTED	10	6
Overall Study COMPLETED	9	6
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Control Cookie, Then Fibersym Cookie Participants consumed 109g of control cookies (about 3.5 cookies - at least 1 cookie at each main meal) daily for 3 days. On the evening of the 3rd day they consumed the frozen dinner they had been provided with. They came to the test center the next morning after an overnight fast when the glucose and insulin responses elicited by 78.1g of control cookie (40g available carbohydrate) were measured. After a 6-28 day washout period participants repeated the process, consuming 136g of Fibersym cookies (about 4 cookies, 29g fiber, at least 1 with each main meal) daily for 3 days, consuming the standard dinner on the 3rd day and after an overnight fasting having glucose and insulin responses elicited by 97.8g Fibersym cookie (40g available carbohydrate) measured.	Fibersym Cookie First Participants consumed 136g of Fibersym cookies (about 4 cookies, 29g fiber, at least 1 cookie at each main meal) daily for 3 days. On the evening of the 3rd day they consumed the frozen dinner they had been provided with. They came to the test center the next morning after an overnight fast when the glucose and insulin responses elicited by 97.8g of Fibersym cookie (40g available carbohydrate) were measured. After a 6-28 day washout period participants repeated the process, consuming 109g of control cookies (about 3.5 cookies, at least 1 with each main meal) daily for 3 days, consuming the standard dinner on the 3rd day and after an overnight fasting having glucose and insulin responses elicited by 78.1g Control cookie (40g available carbohydrate) measured.
Overall Study Adverse Event	1	0

Baseline Characteristics

Comparison of the Postprandial Glycemic and Insulinemic Response After a Fibersym Containing Cookie With a Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Cookie First Followed by Fibersym Cookie n=10 Participants Participants consumed 109g of control cookies (about 3.5 cookies - at least 1 cookie at each main meal) daily for 3 days. On the evening of the 3rd day they consumed the frozen dinner they had been provided with. They came to the test center the next morning after an overnight fast when the glucose and insulin responses elicited by 78.1g of control cookie (40g available carbohydrate) were measured. After a 6-28 day washout period participants repeated the process, consuming 136g of Fibersym cookies (about 4 cookies, 29g fiber, at least 1 with each main meal) daily for 3 days, consuming the standard dinner on the 3rd day and after an overnight fasting having glucose and insulin responses elicited by 97.8g Fibersym cookie (40g available carbohydrate) measured.	Fibersym Cookie First Followed by Control Cookie n=6 Participants Participants consumed 136g of Fibersym cookies (about 4 cookies, 29g fiber, at least 1 cookie at each main meal) daily for 3 days. On the evening of the 3rd day they consumed the frozen dinner they had been provided with. They came to the test center the next morning after an overnight fast when the glucose and insulin responses elicited by 97.8g of Fibersym cookie (40g available carbohydrate) were measured. After a 6-28 day washout period participants repeated the process, consuming 109g of control cookies (about 3.5 cookies, at least 1 with each main meal) daily for 3 days, consuming the standard dinner on the 3rd day and after an overnight fasting having glucose and insulin responses elicited by 78.1g Control cookie (40g available carbohydrate) measured.	Total n=16 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 12 • n=5 Participants	29 years STANDARD_DEVIATION 8 • n=7 Participants	31 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	10 participants n=5 Participants	6 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

2-hour postprandial glucose incremental area under the curve (IAUC), calculated from blood samples taken 5 min prior to meal, 0, 15, 30, 45, 60, 90 and 120 min after the start of the test meal.

Outcome measures

Outcome measures
Measure	Control Cookie n=15 Participants a sugarsnap cookie baked specifically for this trial Control cookie: control cookie	Fibersym Cookie n=15 Participants a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added Fibersym: RS4-type resistant modified wheat starch
2-hour Postprandial Glucose Incremental Area Under the Curve (IAUC)	124 mmol*min/L Standard Error 16	106 mmol*min/L Standard Error 16

SECONDARY outcome

Timeframe: 2 hours

2-hour postprandial insulin incremental area under the curve (IAUC) calculated from blood samples taken 5 min prior to meal, 0, 15, 30, 45, 60, 90 and 120 min after the start of the test meal.

Outcome measures

Outcome measures
Measure	Control Cookie n=15 Participants a sugarsnap cookie baked specifically for this trial Control cookie: control cookie	Fibersym Cookie n=15 Participants a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added Fibersym: RS4-type resistant modified wheat starch
2-hour Postprandial Insulin Incremental Area Under the Curve (IAUC)	245 pmol*h/L Standard Error 24	189 pmol*h/L Standard Error 21

SECONDARY outcome

Timeframe: 4 days

The occurrence of abdominal bloating (none, mild, moderate or severe) daily before breakfast during the three days of each pre-feeding period and before consuming the test meal on day 4.

Outcome measures

Outcome measures
Measure	Control Cookie n=15 Participants a sugarsnap cookie baked specifically for this trial Control cookie: control cookie	Fibersym Cookie n=15 Participants a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added Fibersym: RS4-type resistant modified wheat starch
Abdominal Bloating	8 Participants	8 Participants

SECONDARY outcome

Timeframe: 4 days

The occurrence of belching (none, mild, moderate or severe) daily before breakfast during the three days of each pre-feeding period and before consuming the test meal on day 4.

Outcome measures

Outcome measures
Measure	Control Cookie n=15 Participants a sugarsnap cookie baked specifically for this trial Control cookie: control cookie	Fibersym Cookie n=15 Participants a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added Fibersym: RS4-type resistant modified wheat starch
Belching	9 Participants	10 Participants

SECONDARY outcome

Timeframe: 4 days

The occurrence of nausea (none, mild, moderate or severe) daily before breakfast during the three days of each pre-feeding period and before consuming the test meal on day 4.

Outcome measures

Outcome measures
Measure	Control Cookie n=15 Participants a sugarsnap cookie baked specifically for this trial Control cookie: control cookie	Fibersym Cookie n=15 Participants a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added Fibersym: RS4-type resistant modified wheat starch
Nausea	8 Participants	9 Participants

SECONDARY outcome

Timeframe: 4 days

The occurrence of diarrhea (none, mild, moderate or severe) daily before breakfast during the three days of each pre-feeding period and before consuming the test meal on day 4.

Outcome measures

Outcome measures
Measure	Control Cookie n=15 Participants a sugarsnap cookie baked specifically for this trial Control cookie: control cookie	Fibersym Cookie n=15 Participants a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added Fibersym: RS4-type resistant modified wheat starch
Diarrhea	6 Participants	7 Participants

SECONDARY outcome

Timeframe: 4 days

The occurrence of flatulence (none, mild, moderate or severe) daily before breakfast during the three days of each pre-feeding period and before consuming the test meal on day 4.

Outcome measures

Outcome measures
Measure	Control Cookie n=15 Participants a sugarsnap cookie baked specifically for this trial Control cookie: control cookie	Fibersym Cookie n=15 Participants a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added Fibersym: RS4-type resistant modified wheat starch
Flatulence	11 Participants	12 Participants

SECONDARY outcome

Timeframe: 2 hours

Satiety is the mean of 4 measures, hunger (H), fullness (F), desire to eat (D) and prospective consumption (how much do you think you can eat) (P) each measured using visual analogue scales (VAS) at intervals over the postprandial period. A VAS is a 100mm line anchored at the right end with phrase indicating a high in tensity of the feeling (eg. as hungry as I have ever felt) and at the left other end with a phrase indicating a low intensity of feeling (eg. not hungry at all). For each measure the minimum score is 0 and the maximum score is 100, as measured in mm from the left end. Higher scores mean more hungry, less full, more desire to eat and high prospective consumption (can eat a large amount). The mean score is calculated as (H - F + D + P)/4.

Outcome measures

Outcome measures
Measure	Control Cookie n=15 Participants a sugarsnap cookie baked specifically for this trial Control cookie: control cookie	Fibersym Cookie n=15 Participants a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added Fibersym: RS4-type resistant modified wheat starch
Satiety Scores	79 mm Standard Error 9	70 mm Standard Error 8

POST_HOC outcome

Timeframe: 90 min

Incremental area under the curve from 0 to 90 min calculated from blood samples taken 5 min prior to meal, 0, 15, 30, 45, 60 and 90 min after the start of the test meal.

Outcome measures

Outcome measures
Measure	Control Cookie n=15 Participants a sugarsnap cookie baked specifically for this trial Control cookie: control cookie	Fibersym Cookie n=15 Participants a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added Fibersym: RS4-type resistant modified wheat starch
0-90min Incremental Area Under the Glucose Curve	108 mmol*min/L Standard Error 13	87 mmol*min/L Standard Error 12

POST_HOC outcome

Timeframe: 90 min

Incremental area under the curve from 0 to 90 min calculated from blood samples taken 5 min prior to meal, 0, 15, 30, 45, 60 and 90 min after the start of the test meal.

Outcome measures

Outcome measures
Measure	Control Cookie n=15 Participants a sugarsnap cookie baked specifically for this trial Control cookie: control cookie	Fibersym Cookie n=15 Participants a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added Fibersym: RS4-type resistant modified wheat starch
0-90min Incremental Area Under the Insulin Curve	216 pmol*h/L Standard Error 21	162 pmol*h/L Standard Error 18

POST_HOC outcome

Timeframe: 2 hours

Difference between fasting and maximum glucose concentration during the test

Outcome measures

Outcome measures
Measure	Control Cookie n=15 Participants a sugarsnap cookie baked specifically for this trial Control cookie: control cookie	Fibersym Cookie n=15 Participants a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added Fibersym: RS4-type resistant modified wheat starch
Glucose Peak Rise	2.20 mmol/L Standard Error 0.24	1.72 mmol/L Standard Error 0.23

Adverse Events

Control Cookie

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Fibersym Cookie

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control Cookie n=16 participants at risk a sugarsnap cookie baked specifically for this trial Control cookie: control cookie	Fibersym Cookie n=15 participants at risk a sugarsnap cookie baked using the same methodology for the control cookie but with the resistants starch RS4, Fibersym, added Fibersym: RS4-type resistant modified wheat starch
Respiratory, thoracic and mediastinal disorders Infection	6.2% 1/16 • Number of events 1 • 1 month	0.00% 0/15 • 1 month

Additional Information

Principal Scientist

INQUIS Clinical Research

Phone: 4168619177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place