Trial Outcomes & Findings for Consumption of Oral Artificial Sweeteners on Platelet Aggregation and Polyol Excretion (NCT NCT04731363)
NCT ID: NCT04731363
Last Updated: 2025-06-11
Results Overview
Measuring platelet function 30 minutes after polyol ingestion, using established in vitro platelet assays. Platelet aggregation responses, based on changes in light transmission after adding different concentrations of the agonists ADP and TRAP6 are reported. A higher percentage of light transmission indicates an increased aggregation response, with maximum amplitude (100%) indicating total aggregation.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
30 minutes
Results posted on
2025-06-11
Participant Flow
Participant milestones
| Measure |
Xylitol, 30g
oral xylitol, a potent artificial sweetener
xylitol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
|
Erythritol, 30g
oral erythritol, a potent artificial sweetener
erythritol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
|
Xylitol, 5g
oral xylitol, a potent artificial sweetener
xylitol, 5g: Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose.
|
Glucose, 30g
oral glucose, delivered as dextrose
glucose, 30g: Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
25
|
5
|
10
|
|
Overall Study
COMPLETED
|
10
|
23
|
5
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Xylitol, 30g
oral xylitol, a potent artificial sweetener
xylitol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
|
Erythritol, 30g
oral erythritol, a potent artificial sweetener
erythritol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
|
Xylitol, 5g
oral xylitol, a potent artificial sweetener
xylitol, 5g: Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose.
|
Glucose, 30g
oral glucose, delivered as dextrose
glucose, 30g: Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose.
|
|---|---|---|---|---|
|
Overall Study
Could not obtain samples
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Consumption of Oral Artificial Sweeteners on Platelet Aggregation and Polyol Excretion
Baseline characteristics by cohort
| Measure |
Xylitol, 30g
n=10 Participants
oral xylitol, a potent artificial sweetener
xylitol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
|
Erythritol, 30g
n=23 Participants
oral erythritol, a potent artificial sweetener
erythritol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
|
Xylitol, 5g
n=5 Participants
oral xylitol, a potent artificial sweetener
xylitol, 5g: Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose.
|
Glucose, 30g
n=10 Participants
oral glucose, delivered as dextrose
glucose, 30g: Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 14.0 • n=7 Participants
|
31.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
30.1 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
34.1 years
STANDARD_DEVIATION 12.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
23 participants
n=7 Participants
|
5 participants
n=5 Participants
|
10 participants
n=4 Participants
|
48 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: Only 10 of the 23 subjects consuming 30g of erythritol had aggregometry measurements performed. These were the last 10 subjects enrolled in this arm. The earlier subjects were only used to assess levels of erythritol following ingestion (pharmacokinetics studies) without looking at platelet function. The pharmacokinetics studies informed the subsequent aggregometry experiments in the final 10 subjects.
Measuring platelet function 30 minutes after polyol ingestion, using established in vitro platelet assays. Platelet aggregation responses, based on changes in light transmission after adding different concentrations of the agonists ADP and TRAP6 are reported. A higher percentage of light transmission indicates an increased aggregation response, with maximum amplitude (100%) indicating total aggregation.
Outcome measures
| Measure |
Xylitol, 30g
n=10 Participants
oral xylitol, a potent artificial sweetener
xylitol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
|
Erythritol, 30g
n=10 Participants
oral erythritol, a potent artificial sweetener
erythritol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
|
Xylitol, 5g
n=5 Participants
oral xylitol, a potent artificial sweetener
xylitol, 5g: Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose.
|
Glucose, 30g
n=10 Participants
oral glucose, delivered as dextrose
glucose, 30g: Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose.
|
|---|---|---|---|---|
|
Platelet Aggregation After Polyol Ingestion
ADP (1 uM)
|
20.00 % of maximum amplitude
Interval 16.0 to 25.0
|
18.50 % of maximum amplitude
Interval 14.25 to 23.0
|
20.00 % of maximum amplitude
Interval 16.25 to 23.0
|
12.00 % of maximum amplitude
Interval 10.0 to 13.75
|
|
Platelet Aggregation After Polyol Ingestion
ADP (2 uM)
|
33.00 % of maximum amplitude
Interval 30.0 to 40.0
|
34.00 % of maximum amplitude
Interval 29.0 to 39.5
|
29.00 % of maximum amplitude
Interval 23.0 to 33.0
|
22.00 % of maximum amplitude
Interval 20.0 to 24.0
|
|
Platelet Aggregation After Polyol Ingestion
ADP (3 uM)
|
43.50 % of maximum amplitude
Interval 41.0 to 61.0
|
42.50 % of maximum amplitude
Interval 37.0 to 52.0
|
44.00 % of maximum amplitude
Interval 39.0 to 48.0
|
31.00 % of maximum amplitude
Interval 27.0 to 33.0
|
|
Platelet Aggregation After Polyol Ingestion
ADP (4 uM)
|
57.00 % of maximum amplitude
Interval 53.0 to 70.0
|
66.50 % of maximum amplitude
Interval 55.0 to 70.75
|
72.50 % of maximum amplitude
Interval 63.75 to 77.25
|
49.00 % of maximum amplitude
Interval 45.5 to 56.5
|
|
Platelet Aggregation After Polyol Ingestion
TRAP6 (2.5uM)
|
13.00 % of maximum amplitude
Interval 9.5 to 24.0
|
15.00 % of maximum amplitude
Interval 8.0 to 21.25
|
9.00 % of maximum amplitude
Interval 5.0 to 17.0
|
1.00 % of maximum amplitude
Interval 0.0 to 3.0
|
|
Platelet Aggregation After Polyol Ingestion
TRAP6 (5.0uM)
|
32.00 % of maximum amplitude
Interval 19.0 to 49.0
|
26.00 % of maximum amplitude
Interval 17.5 to 38.0
|
16.50 % of maximum amplitude
Interval 10.75 to 26.0
|
8.00 % of maximum amplitude
Interval 5.5 to 12.0
|
|
Platelet Aggregation After Polyol Ingestion
TRAP6 (7.5 uM)
|
50.00 % of maximum amplitude
Interval 37.5 to 72.5
|
45.00 % of maximum amplitude
Interval 34.0 to 53.5
|
37.00 % of maximum amplitude
Interval 29.0 to 60.0
|
20.00 % of maximum amplitude
Interval 18.0 to 23.0
|
|
Platelet Aggregation After Polyol Ingestion
TRAP6 (10.0uM)
|
68.00 % of maximum amplitude
Interval 59.5 to 73.5
|
69.00 % of maximum amplitude
Interval 64.0 to 75.0
|
78.00 % of maximum amplitude
Interval 67.0 to 86.0
|
61.00 % of maximum amplitude
Interval 51.5 to 65.5
|
PRIMARY outcome
Timeframe: Baseline and 30 minutes post ingestion of polyol interventionPopulation: Only 10 of the 23 subjects consuming 30g of erythritol had aggregometry measurements performed. These were the last 10 subjects enrolled in this arm. The earlier subjects were only used to assess levels of erythritol following ingestion (pharmacokinetics studies) without looking at platelet function. The pharmacokinetics studies informed the subsequent aggregometry experiments in the final 10 subjects.
Measuring changes in platelet function before versus after xylitol or erythritol ingestion, using established in vitro platelet assays. Platelet aggregation responses, based on changes in light transmission after adding different concentrations of the agonists ADP and TRAP6 are reported. A higher percentage of light transmission indicates an increased aggregation response, with maximum amplitude (100%) indicating total aggregation.
Outcome measures
| Measure |
Xylitol, 30g
n=10 Participants
oral xylitol, a potent artificial sweetener
xylitol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
|
Erythritol, 30g
n=10 Participants
oral erythritol, a potent artificial sweetener
erythritol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
|
Xylitol, 5g
n=5 Participants
oral xylitol, a potent artificial sweetener
xylitol, 5g: Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose.
|
Glucose, 30g
n=10 Participants
oral glucose, delivered as dextrose
glucose, 30g: Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose.
|
|---|---|---|---|---|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
1uM ADP at Baseline
|
11.00 % of maximum amplitude
Interval 9.0 to 13.0
|
11.00 % of maximum amplitude
Interval 9.0 to 13.0
|
11.00 % of maximum amplitude
Interval 8.0 to 13.0
|
11.50 % of maximum amplitude
Interval 9.0 to 13.0
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
1uM ADP at 30 minutes post polyol ingestion
|
20.00 % of maximum amplitude
Interval 16.0 to 25.0
|
18.50 % of maximum amplitude
Interval 14.25 to 23.0
|
20.00 % of maximum amplitude
Interval 16.25 to 23.0
|
12.00 % of maximum amplitude
Interval 10.0 to 13.75
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
2 uM ADP at Baseline
|
21.00 % of maximum amplitude
Interval 19.0 to 23.0
|
22.00 % of maximum amplitude
Interval 18.0 to 25.0
|
19.00 % of maximum amplitude
Interval 16.0 to 24.0
|
21.00 % of maximum amplitude
Interval 18.0 to 23.0
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
2 uM ADP at 30 minutes post polyol ingestion
|
33.00 % of maximum amplitude
Interval 30.0 to 40.0
|
34.00 % of maximum amplitude
Interval 29.0 to 39.5
|
29.00 % of maximum amplitude
Interval 23.0 to 33.0
|
22.00 % of maximum amplitude
Interval 20.0 to 24.0
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
3uM ADP at Baseline
|
30.00 % of maximum amplitude
Interval 28.0 to 31.75
|
30.00 % of maximum amplitude
Interval 28.0 to 34.0
|
31.00 % of maximum amplitude
Interval 28.0 to 33.0
|
30.00 % of maximum amplitude
Interval 28.0 to 32.0
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
4uM ADP at Baseline
|
45.00 % of maximum amplitude
Interval 38.0 to 50.0
|
50.50 % of maximum amplitude
Interval 46.0 to 57.75
|
52.00 % of maximum amplitude
Interval 47.0 to 54.5
|
50.00 % of maximum amplitude
Interval 46.0 to 53.5
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
4uM ADP at 30 minutes post polyol ingestion
|
57.00 % of maximum amplitude
Interval 53.0 to 70.0
|
66.50 % of maximum amplitude
Interval 55.0 to 70.75
|
72.50 % of maximum amplitude
Interval 63.75 to 77.25
|
49.00 % of maximum amplitude
Interval 45.5 to 56.5
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
2.5 uM TRAP6 at Baseline
|
2.50 % of maximum amplitude
Interval 1.0 to 4.0
|
2.50 % of maximum amplitude
Interval 1.0 to 3.25
|
2.00 % of maximum amplitude
Interval 0.0 to 4.0
|
1.00 % of maximum amplitude
Interval 0.0 to 3.0
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
2.5 uM TRAP6 at 30 minutes post polyol ingestion
|
13.00 % of maximum amplitude
Interval 9.5 to 24.0
|
15.00 % of maximum amplitude
Interval 8.0 to 21.25
|
9.00 % of maximum amplitude
Interval 5.0 to 17.0
|
1.00 % of maximum amplitude
Interval 0.0 to 3.0
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
5.0 uM TRAP6 at Baseline
|
9.00 % of maximum amplitude
Interval 8.0 to 12.0
|
9.00 % of maximum amplitude
Interval 7.0 to 12.0
|
9.00 % of maximum amplitude
Interval 7.0 to 10.25
|
9.00 % of maximum amplitude
Interval 8.0 to 11.0
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
5.0 uM TRAP6 at 30 minutes post polyol ingestion
|
32.00 % of maximum amplitude
Interval 19.0 to 49.0
|
26.00 % of maximum amplitude
Interval 17.5 to 38.0
|
16.50 % of maximum amplitude
Interval 10.75 to 26.0
|
8.00 % of maximum amplitude
Interval 5.5 to 12.0
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
7.5 uM TRAP6 at Baseline
|
20.00 % of maximum amplitude
Interval 17.0 to 23.5
|
20.00 % of maximum amplitude
Interval 17.0 to 23.0
|
21.00 % of maximum amplitude
Interval 18.0 to 25.0
|
19.00 % of maximum amplitude
Interval 17.0 to 22.0
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
7.5 uM TRAP6 at 30 minutes post polyol ingestion
|
50.00 % of maximum amplitude
Interval 37.5 to 72.5
|
45.00 % of maximum amplitude
Interval 34.0 to 53.5
|
37.00 % of maximum amplitude
Interval 29.0 to 60.0
|
20.00 % of maximum amplitude
Interval 18.0 to 23.0
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
10.0 uM TRAP6 at Baseline
|
45.50 % of maximum amplitude
Interval 40.0 to 50.0
|
48.00 % of maximum amplitude
Interval 45.0 to 54.0
|
60.00 % of maximum amplitude
Interval 46.0 to 64.0
|
61.50 % of maximum amplitude
Interval 58.5 to 65.0
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
10.0 uM TRAP6 at 30 minutes post polyol ingestion
|
68.00 % of maximum amplitude
Interval 59.5 to 73.5
|
69.00 % of maximum amplitude
Interval 64.0 to 75.0
|
78.00 % of maximum amplitude
Interval 67.0 to 86.0
|
61.00 % of maximum amplitude
Interval 51.5 to 65.5
|
|
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
3uM ADP at 30 minutes post polyol ingestion
|
43.50 % of maximum amplitude
Interval 41.0 to 61.0
|
42.50 % of maximum amplitude
Interval 37.0 to 52.0
|
44.00 % of maximum amplitude
Interval 39.0 to 48.0
|
31.00 % of maximum amplitude
Interval 27.0 to 33.0
|
PRIMARY outcome
Timeframe: 30 minutesMeasuring plasma levels (uM) of polyols (xylitol or erythritol) 30 minutes after xylitol or erythritol ingestion, using established techniques by mass spectrometry. Xylitol was measured, and is reported below, in the two xylitol intervention arms and erythritol was measured, and is reported below, in the erythritol and glucose intervention arms.
Outcome measures
| Measure |
Xylitol, 30g
n=10 Participants
oral xylitol, a potent artificial sweetener
xylitol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
|
Erythritol, 30g
n=23 Participants
oral erythritol, a potent artificial sweetener
erythritol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
|
Xylitol, 5g
n=5 Participants
oral xylitol, a potent artificial sweetener
xylitol, 5g: Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose.
|
Glucose, 30g
n=10 Participants
oral glucose, delivered as dextrose
glucose, 30g: Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose.
|
|---|---|---|---|---|
|
Plasma Polyol Levels After Polyol Ingestion
|
312.4 uM
Interval 133.9 to 628.5
|
6174.9 uM
Interval 5546.5 to 7034.3
|
0.97 uM
Interval 0.95 to 1.43
|
2.9 uM
Interval 2.7 to 3.8
|
PRIMARY outcome
Timeframe: Baseline and 30 minutes post ingestion of polyol interventionMeasuring changes in levels of plasma polyols before versus after xylitol or erythritol ingestion, using established techniques by mass spectrometry. Xylitol concentrations are reported in the two xylitol intervention arms. Erythritol concentrations are reported in the erythritol and glucose intervention arms.
Outcome measures
| Measure |
Xylitol, 30g
n=10 Participants
oral xylitol, a potent artificial sweetener
xylitol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
|
Erythritol, 30g
n=23 Participants
oral erythritol, a potent artificial sweetener
erythritol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
|
Xylitol, 5g
n=5 Participants
oral xylitol, a potent artificial sweetener
xylitol, 5g: Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose.
|
Glucose, 30g
n=10 Participants
oral glucose, delivered as dextrose
glucose, 30g: Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose.
|
|---|---|---|---|---|
|
Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion
Baseline
|
0.30 umol/L (uM)
Interval 0.27 to 0.34
|
3.8 umol/L (uM)
Interval 3.5 to 4.1
|
0.26 umol/L (uM)
Interval 0.23 to 0.38
|
3.0 umol/L (uM)
Interval 2.6 to 4.0
|
|
Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion
30 minutes post-ingestion of polyol
|
312.4 umol/L (uM)
Interval 133.9 to 628.5
|
6174.9 umol/L (uM)
Interval 5546.5 to 7034.3
|
0.97 umol/L (uM)
Interval 0.95 to 1.43
|
2.9 umol/L (uM)
Interval 2.7 to 3.8
|
PRIMARY outcome
Timeframe: 30 minutesMeasuring the urinary levels of polyols (xylitol or erythritol) 30 minutes after xylitol or erythritol ingestion, using established techniques by mass spectrometry. Xylitol was measured, and is reported below, in the two xylitol intervention arms and erythritol was measured, and is reported below, in the erythritol and glucose intervention arms.
Outcome measures
| Measure |
Xylitol, 30g
n=10 Participants
oral xylitol, a potent artificial sweetener
xylitol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
|
Erythritol, 30g
n=23 Participants
oral erythritol, a potent artificial sweetener
erythritol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
|
Xylitol, 5g
n=5 Participants
oral xylitol, a potent artificial sweetener
xylitol, 5g: Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose.
|
Glucose, 30g
n=10 Participants
oral glucose, delivered as dextrose
glucose, 30g: Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose.
|
|---|---|---|---|---|
|
Urinary Polyol Levels After Polyol Ingestion
|
5242.00 uM
Interval 1500.06 to 16662.0
|
86832.00 uM
Interval 64506.0 to 162204.0
|
29.20 uM
Interval 9.88 to 75.84
|
225.56 uM
Interval 92.32 to 471.78
|
PRIMARY outcome
Timeframe: Baseline and 30 minutes post ingestion of polyol interventionMeasuring changes in levels of urinary polyols before versus after xylitol or erythritol ingestion, using established techniques by mass spectrometry. Xylitol was measured, and is reported below, in the two xylitol intervention arms and erythritol was measured, and is reported below, in the erythritol and glucose intervention arms.
Outcome measures
| Measure |
Xylitol, 30g
n=10 Participants
oral xylitol, a potent artificial sweetener
xylitol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
|
Erythritol, 30g
n=23 Participants
oral erythritol, a potent artificial sweetener
erythritol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
|
Xylitol, 5g
n=5 Participants
oral xylitol, a potent artificial sweetener
xylitol, 5g: Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose.
|
Glucose, 30g
n=10 Participants
oral glucose, delivered as dextrose
glucose, 30g: Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose.
|
|---|---|---|---|---|
|
Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion
Baseline
|
42.24 uM
Interval 27.32 to 51.9
|
372.56 uM
Interval 220.7 to 566.76
|
18.92 uM
Interval 5.36 to 59.72
|
393.84 uM
Interval 260.49 to 629.45
|
|
Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion
30-minutes Post Polyol Ingestion
|
5242.00 uM
Interval 1500.06 to 16662.0
|
86832.00 uM
Interval 64506.0 to 162204.0
|
29.20 uM
Interval 9.88 to 75.84
|
225.56 uM
Interval 92.32 to 471.78
|
SECONDARY outcome
Timeframe: Baseline and 1 day post ingestion of polyol interventionPopulation: Not all subjects had blood drawn at 1 day post-sweetener ingestion. Blood samples at 1 day post ingestion were only obtained from 13 subjects who consumed 30g erythritol and 4 subjects who consumed 30g of xylitol. No subjects taking glucose or 5mg of xylitol had blood drawn at 1 day post-ingestion.
Measuring changes in lipid levels as markers of changes in metabolism before versus after xylitol or erythritol ingestion.
Outcome measures
| Measure |
Xylitol, 30g
n=4 Participants
oral xylitol, a potent artificial sweetener
xylitol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
|
Erythritol, 30g
n=13 Participants
oral erythritol, a potent artificial sweetener
erythritol, 30g: Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
|
Xylitol, 5g
oral xylitol, a potent artificial sweetener
xylitol, 5g: Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose.
|
Glucose, 30g
oral glucose, delivered as dextrose
glucose, 30g: Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose.
|
|---|---|---|---|---|
|
Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion
Triglycerides at 1 day Post Polyol Ingestion
|
106.0 mg/dL
Interval 81.8 to 132.3
|
86.0 mg/dL
Interval 63.0 to 103.0
|
—
|
—
|
|
Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion
Calculated LDL at Baseline
|
112.2 mg/dL
Interval 55.0 to 170.2
|
91.0 mg/dL
Interval 75.0 to 116.0
|
—
|
—
|
|
Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion
Calculated LDL at 1 day Post Polyol Ingestion
|
134.0 mg/dL
Interval 123.5 to 148.8
|
97.0 mg/dL
Interval 76.0 to 122.0
|
—
|
—
|
|
Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion
HDL at Baseline
|
50.6 mg/dL
Interval 46.7 to 57.8
|
51.6 mg/dL
Interval 49.2 to 64.9
|
—
|
—
|
|
Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion
HDL at 1 day Post Polyol Ingestion
|
48.4 mg/dL
Interval 46.0 to 56.7
|
52.4 mg/dL
Interval 47.7 to 61.9
|
—
|
—
|
|
Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion
Triglycerides at Baseline
|
108.5 mg/dL
Interval 93.0 to 133.5
|
80.0 mg/dL
Interval 59.0 to 104.0
|
—
|
—
|
|
Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion
Total Cholesterol at Baseline
|
218.5 mg/dL
Interval 207.8 to 226.0
|
168.0 mg/dL
Interval 143.0 to 192.0
|
—
|
—
|
|
Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion
Total Cholesterol at 1 day Post Polyol Ingestion
|
203.5 mg/dL
Interval 200.5 to 217.0
|
168.0 mg/dL
Interval 145.0 to 199.0
|
—
|
—
|
Adverse Events
Xylitol, 30g
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Erythritol, 30g
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Xylitol, 5g
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glucose, 30g
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