Trial Outcomes & Findings for Pilot Study Evaluating the Acceptability and Absorption of the Bioactive Compounds of a Russian Tarragon Nutrasorb Bar (NCT NCT05130593)

Last Updated: 2023-11-18

Results Overview

Participants were asked to rate the bar on a visual analog scale to indicate their impression of its visual appearance, smell, taste, texture, aftertaste, and overall pleasantness. The scale range for each attribute is 0-100 with higher scores equating to a better outcome.

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

Test Day (immediately after taste-testing the bar)

Results posted on

2023-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1 Participants taste-tested a bar containing PMI-5011/Nutrasorb for acceptability. Nutrasorb bar: 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings	Phase 2 Participants consumed a bar containing PMI-5011/Nutrasorb and had blood samples drawn for measurement of safety parameters (glucose and insulin) and bioactive compounds (DMC-2). Nutrasorb bar: 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study Evaluating the Acceptability and Absorption of the Bioactive Compounds of a Russian Tarragon Nutrasorb Bar

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Test Day (immediately after taste-testing the bar)

Population: Only the participants in Phase 1 of the study participated in taste-testing of the bar for palatability. Participants from Phase 1 were not allowed to participate in Phase 2.

Outcome measures

Outcome measures
Measure	Phase 1 n=10 Participants Participants taste-tested a bar containing PMI-5011/Nutrasorb for acceptability. Nutrasorb bar: 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings
Palatability of Bar Visual Appearance	77.4 score on a scale Standard Deviation 19.7
Palatability of Bar Smell	59.5 score on a scale Standard Deviation 19.2
Palatability of Bar Taste	27.8 score on a scale Standard Deviation 24.4
Palatability of Bar Texture	50.6 score on a scale Standard Deviation 20.8
Palatability of Bar Aftertaste	56.5 score on a scale Standard Deviation 31.4
Palatability of Bar Pleasantness	32.2 score on a scale Standard Deviation 25.6

SECONDARY outcome

Timeframe: 10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption

Population: Only the participants in Phase 2 of the study had blood samples drawn for measurement of bioactive compounds (DMC-2). Participants from Phase 1 were not allowed to participate in Phase 2.

Participants consumed a bar containing PMI-5011 and Nutrasorb and had blood samples drawn for measurement of DMC-2. Nutrasorb bar: 250 kcal bar containing 30 g of PMI-5011/Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings

Outcome measures

Outcome measures
Measure	Phase 1 n=10 Participants Participants taste-tested a bar containing PMI-5011/Nutrasorb for acceptability. Nutrasorb bar: 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings
Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. - 10 min	0.05 ug/mL Standard Deviation 0.00
Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 0 min	0.05 ug/mL Standard Deviation 0.00
Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 30 min	0.094 ug/mL Standard Deviation 0.026
Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 60 min	0.076 ug/mL Standard Deviation 0.022
Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 120 min	0.087 ug/mL Standard Deviation 0.026
Levels of Plasma BIoactive (DMC-2) Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 180 min	0.074 ug/mL Standard Deviation 0.013

SECONDARY outcome

Timeframe: 10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption

Population: Only the participants in Phase 2 of the study had blood samples drawn for measurement of serum glucose. Participants from Phase 1 were not allowed to participate in Phase 2.

Participants consumed a bar containing PMI-5011 and Nutrasorb and had blood samples drawn for measurement of safety parameters (glucose). Nutrasorb bar: 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings

Outcome measures

Outcome measures
Measure	Phase 1 n=10 Participants Participants taste-tested a bar containing PMI-5011/Nutrasorb for acceptability. Nutrasorb bar: 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings
Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 60 min	91 mg/dL Standard Deviation 5.5
Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. -10 min	88 mg/dL Standard Deviation 6.2
Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 0 min	89 mg/dL Standard Deviation 5.5
Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 30 min	91 mg/dL Standard Deviation 6.9
Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 120 min	90 mg/dL Standard Deviation 4.7
Levels of Serum Glucose Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 180 min	89 mg/dL Standard Deviation 5.1

SECONDARY outcome

Timeframe: 10 minutes pre-consumption, immediately post-consumption, and 30, 60, 120, and 180 minutes post-consumption

Population: Only the participants in Phase 2 of the study had blood samples drawn for measurement of insulin. Participants from Phase 1 were not allowed to participate in Phase 2.

Participants consumed a bar containing PMI-5011 and Nutrasorb and had blood samples drawn for measurement of safety parameters (insulin). Nutrasorb bar: 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings

Outcome measures

Outcome measures
Measure	Phase 1 n=10 Participants Participants taste-tested a bar containing PMI-5011/Nutrasorb for acceptability. Nutrasorb bar: 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings
Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. -10 min	9.6 uIU/mL Standard Deviation 12.8
Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 0 min	10.4 uIU/mL Standard Deviation 13.9
Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 30 min	30.7 uIU/mL Standard Deviation 30.5
Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 60 min	25.8 uIU/mL Standard Deviation 31.4
Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 120 min	14.3 uIU/mL Standard Deviation 16.7
Measurement of Blood Levels of Serum Insulin Before and After Ingestion of a Bar Containing PMI-5011/Nutrasorb. 180 min	7.2 uIU/mL Standard Deviation 6.4

Adverse Events

Phase 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 2

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

Jennifer C Rood, PhD

Pennington Biomedical Research Center

Phone: 225-763-2524

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase 1 n=10 Participants Participants taste-tested a bar containing PMI-5011/Nutrasorb for acceptability. Nutrasorb bar: 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings	Phase 2 n=10 Participants Participants consumed a bar containing PMI-5011/Nutrasorb and had blood samples drawn for measurement of safety parameters (glucose and insulin) and bioactive compounds (DMC-2). Nutrasorb bar: 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	10 Participants n=7 Participants	17 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 United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants