Trial Outcomes & Findings for Fructose Consumption and Metabolic Dysregulation (NCT NCT01445730)
NCT ID: NCT01445730
Last Updated: 2021-06-15
Results Overview
Before vs. after fructose challenge: Triglycerides (TG) plasma Area Under Curve (AUC)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
Form the baseline (time point 1) to end of treatment at 3 months (time point 2)
Results posted on
2021-06-15
Participant Flow
Participant milestones
| Measure |
After Fructose Feeding
After 3 month fructose diet 75 g/day
|
|---|---|
|
Overall Study
STARTED
|
82
|
|
Overall Study
COMPLETED
|
71
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
After Fructose Feeding
After 3 month fructose diet 75 g/day
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
For the advice of a dentist
|
1
|
|
Overall Study
The data from magnetic resonance examinations were not sufficient
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
After Fructose Feeding
n=82 Participants
After 3 month fructose diet 75 g/day
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=82 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
82 Participants
n=82 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=82 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=82 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=82 Participants
|
|
Region of Enrollment
Sweden
|
10 participants
n=82 Participants
|
|
Region of Enrollment
Finland
|
50 participants
n=82 Participants
|
|
Region of Enrollment
Italy
|
18 participants
n=82 Participants
|
PRIMARY outcome
Timeframe: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)Before vs. after fructose challenge: Triglycerides (TG) plasma Area Under Curve (AUC)
Outcome measures
| Measure |
After Fructose Feeding
n=71 Participants
After 3 month fructose diet 75 g/day
|
|---|---|
|
TG Plasma AUC
Time point 1
|
1130 mmol/l*min
Standard Deviation 590
|
|
TG Plasma AUC
Time point 2
|
1220 mmol/l*min
Standard Deviation 598
|
PRIMARY outcome
Timeframe: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)Before vs. after fructose challenge: apolipoprotein (apo)B48 plasma Area Under Curve (AUC)
Outcome measures
| Measure |
After Fructose Feeding
n=71 Participants
After 3 month fructose diet 75 g/day
|
|---|---|
|
B48 Plasma AUC
Time point 1
|
7660 mg/l*min
Standard Deviation 3210
|
|
B48 Plasma AUC
Time point 2
|
8200 mg/l*min
Standard Deviation 3340
|
PRIMARY outcome
Timeframe: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)Before vs. after fructose challenge:Triglycerides (TG) plasma incremental Area Under Curve (iAUC)
Outcome measures
| Measure |
After Fructose Feeding
n=71 Participants
After 3 month fructose diet 75 g/day
|
|---|---|
|
TG Plasma iAUC
Time point 1
|
377 mmol/l*min
Standard Deviation 422
|
|
TG Plasma iAUC
Time point 2
|
422 mmol/l*min
Standard Deviation 270
|
SECONDARY outcome
Timeframe: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)Before vs. after fructose challenge: de novo lipogenesis (DNL)
Outcome measures
| Measure |
After Fructose Feeding
n=71 Participants
After 3 month fructose diet 75 g/day
|
|---|---|
|
DNL
Time point 1
|
12.3 μmol/L
Standard Deviation 10
|
|
DNL
Time point 2
|
16.5 μmol/L
Standard Deviation 11
|
SECONDARY outcome
Timeframe: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)Before vs. after fructose challenge: Apolipoprotein C-III (ApoC-III)
Outcome measures
| Measure |
After Fructose Feeding
n=71 Participants
After 3 month fructose diet 75 g/day
|
|---|---|
|
ApoC-III
Time point 1
|
10.4 mg/dL
Standard Deviation 5.1
|
|
ApoC-III
Time point 2
|
11.2 mg/dL
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)Before vs. after fructose challenge: beta-OH butyrate (β-OH butyrate)
Outcome measures
| Measure |
After Fructose Feeding
n=71 Participants
After 3 month fructose diet 75 g/day
|
|---|---|
|
β-OH Butyrate
Time point 1
|
0.699 mg/dL
Standard Deviation 0.55
|
|
β-OH Butyrate
Time point 2
|
0.542 mg/dL
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Form the baseline (time point 1) to end of treatment at 3 months (time point 2)Before vs. after fructose challenge
Outcome measures
| Measure |
After Fructose Feeding
n=71 Participants
After 3 month fructose diet 75 g/day
|
|---|---|
|
Liver Fat
Time point 1
|
6.66 percentage of liver fat content
Standard Deviation 6.1
|
|
Liver Fat
Time point 2
|
7.33 percentage of liver fat content
Standard Deviation 6.6
|
Adverse Events
After Fructose Feeding
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
After Fructose Feeding
n=82 participants at risk
After 3 month fructose diet 75 g/day
|
|---|---|
|
Skin and subcutaneous tissue disorders
skin rash
|
1.2%
1/82 • Number of events 1 • During 3 month fructose diet 75 g/day.
Of the 82 subjects, two subjects discontinued the intervention study: one developed a skin rash, which was considered as possible allergic reaction to flavouring and the other subject discontinued in response to his dentist's advice. In addition, the data from magnetic resonance examinations at baseline or after the fructose intervention were not sufficient from nine subjects for technical reasons to allow the analyses of different fat depots. Thus, 71 subjects completed the full study protocol.
|
Additional Information
Prof. Marja-Riitta Taskinen
Helsinki University and Helsinki University Hospital
Phone: +358-9-4717 1990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place