Trial Outcomes & Findings for Effect of Beta-Glucan on Cholesterol Lowering (NCT NCT01408719)
NCT ID: NCT01408719
Last Updated: 2015-11-05
Results Overview
Fasted total cholesterol concentration will be measured using the automated enzymatic methods.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Beginning and end of each phase
Results posted on
2015-11-05
Participant Flow
Participants were recruited at the Richardson Centre for Functionals Foods and Nutraceuticals, University of Manitoba, Winnipeg during July 2010 to May 2011
Over 200 subjects were screened; 45 subjects were enrolled in the study and randomly assigned to the experimental diets (treatment groups).
Participant milestones
| Measure |
Sequence 1
3g LMW followed by control, followed by 3g HMW, followed by 5g LMW
|
Sequence 2
Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW
|
Sequence 3
3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control
|
Sequence 4
5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control
|
Sequence 5
3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW
|
Sequence 6
control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW
|
Sequence 7
5g LMW, followed by 3g LMW, followed control, followed by 3g HMW
|
Sequence 8
3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW
|
Sequence 9
Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW
|
Sequence 10
Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW
|
Sequence 11
3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW
|
Sequence 12
5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW
|
Sequence 13
3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW
|
Sequence 14
3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control
|
Sequence 15
3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW
|
Sequence 16
3g HMW, followed by 5g LMW, followed 3g LMW, followed by control
|
Sequence 17
3g HMW, followed by 3g LMW, followed 5g LMW, followed by control
|
Sequence 18
5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW
|
Sequence 19
Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW
|
Sequence 20
3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
First Intervention (35 Days)
STARTED
|
2
|
3
|
2
|
2
|
4
|
3
|
2
|
3
|
2
|
1
|
2
|
2
|
2
|
5
|
1
|
2
|
3
|
2
|
1
|
1
|
|
First Intervention (35 Days)
COMPLETED
|
2
|
3
|
1
|
2
|
3
|
3
|
2
|
3
|
1
|
1
|
2
|
2
|
2
|
4
|
1
|
2
|
2
|
2
|
0
|
1
|
|
First Intervention (35 Days)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Washout Period (28 Days)
STARTED
|
2
|
3
|
1
|
2
|
3
|
3
|
2
|
2
|
1
|
1
|
2
|
2
|
1
|
3
|
1
|
1
|
2
|
2
|
0
|
1
|
|
Washout Period (28 Days)
COMPLETED
|
2
|
3
|
1
|
2
|
3
|
3
|
2
|
2
|
1
|
1
|
2
|
2
|
1
|
3
|
1
|
1
|
2
|
2
|
0
|
1
|
|
Washout Period (28 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (35 Days)
STARTED
|
2
|
3
|
1
|
2
|
3
|
3
|
2
|
3
|
1
|
1
|
2
|
2
|
2
|
4
|
1
|
2
|
2
|
2
|
0
|
1
|
|
Second Intervention (35 Days)
COMPLETED
|
2
|
3
|
1
|
2
|
3
|
3
|
2
|
3
|
1
|
1
|
2
|
2
|
2
|
3
|
1
|
2
|
2
|
2
|
0
|
1
|
|
Second Intervention (35 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (35 Days)
STARTED
|
2
|
3
|
1
|
2
|
3
|
3
|
2
|
3
|
1
|
1
|
2
|
2
|
2
|
3
|
1
|
1
|
2
|
2
|
0
|
1
|
|
Third Intervention (35 Days)
COMPLETED
|
2
|
3
|
1
|
2
|
3
|
3
|
2
|
2
|
1
|
1
|
2
|
2
|
2
|
3
|
1
|
1
|
2
|
2
|
0
|
1
|
|
Third Intervention (35 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fourth Intervention (35 Days)
STARTED
|
2
|
3
|
1
|
2
|
3
|
3
|
2
|
2
|
1
|
1
|
2
|
2
|
1
|
3
|
1
|
1
|
2
|
2
|
0
|
1
|
|
Fourth Intervention (35 Days)
COMPLETED
|
2
|
3
|
1
|
2
|
3
|
3
|
2
|
2
|
1
|
1
|
2
|
2
|
1
|
3
|
1
|
1
|
2
|
2
|
0
|
1
|
|
Fourth Intervention (35 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Beta-Glucan on Cholesterol Lowering
Baseline characteristics by cohort
| Measure |
Sequence 1
n=2 Participants
3g LMW followed by control, followed by 3g HMW, followed by 5g LMW
|
Sequence 2
n=3 Participants
Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW
|
Sequence 3
n=1 Participants
3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control
|
Sequence 4
n=2 Participants
5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control
|
Sequence 5
n=3 Participants
3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW
|
Sequence 6
n=3 Participants
control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW
|
Sequence 7
n=2 Participants
5g LMW, followed by 3g LMW, followed control, followed by 3g HMW
|
Sequence 8
n=2 Participants
3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW
|
Sequence 9
n=1 Participants
Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW
|
Sequence 10
n=1 Participants
Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW
|
Sequence 11
n=2 Participants
3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW
|
Sequence 12
n=2 Participants
5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW
|
Sequence 13
n=1 Participants
3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW
|
Sequence 14
n=3 Participants
3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control
|
Sequence 15
n=1 Participants
3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW
|
Sequence 16
n=1 Participants
3g HMW, followed by 5g LMW, followed 3g LMW, followed by control
|
Sequence 17
n=2 Participants
3g HMW, followed by 3g LMW, followed 5g LMW, followed by control
|
Sequence 18
n=1 Participants
5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW
|
Sequence 19
n=1 Participants
Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW
|
Sequence 20
n=1 Participants
3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
40 years
STANDARD_DEVIATION 0 • n=5 Participants
|
63 years
STANDARD_DEVIATION 1.4 • n=4 Participants
|
70 years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
55 years
STANDARD_DEVIATION 14 • n=10 Participants
|
55.5 years
STANDARD_DEVIATION 2.12 • n=115 Participants
|
67 years
STANDARD_DEVIATION 1.4 • n=24 Participants
|
57 years
STANDARD_DEVIATION 0 • n=42 Participants
|
27 years
STANDARD_DEVIATION 0 • n=42 Participants
|
62.5 years
STANDARD_DEVIATION 0.7 • n=42 Participants
|
59.5 years
STANDARD_DEVIATION 4.9 • n=42 Participants
|
62 years
STANDARD_DEVIATION 0 • n=36 Participants
|
59.3 years
STANDARD_DEVIATION 3.8 • n=36 Participants
|
76 years
STANDARD_DEVIATION 0 • n=24 Participants
|
58 years
STANDARD_DEVIATION 0 • n=135 Participants
|
53 years
STANDARD_DEVIATION 8.5 • n=136 Participants
|
59 years
STANDARD_DEVIATION 0 • n=44 Participants
|
65 years
STANDARD_DEVIATION 0 • n=667 Participants
|
59 years
STANDARD_DEVIATION 0 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 10.6 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Beginning and end of each phaseFasted total cholesterol concentration will be measured using the automated enzymatic methods.
Outcome measures
| Measure |
5g LMW Beta Glucan
n=30 Participants
5 gram low molecular weight barley beta-glucan diet for 35 days
Control: Minimal beta-glucan
|
3g HMW Beta Glucan
n=30 Participants
3 gram high molecular weight barley beta-glucan diet for 35 days
3g LMW beta-glucan: 3grams beta-glucan
|
3g LMW Beta Glucan
n=30 Participants
3 grams of low molecular weight beta-glucan diet for 35 days
5g LMW beta-glucan: 5 grams beta-glucan
|
Control
n=30 Participants
control diet containing negligible amount of beta glucan
3g HMW beta-glucan: 3 grams of high molecular weight beta-glucan
|
|---|---|---|---|---|
|
Changs in Total Cholesterol
|
-0.42 mmol/L
Standard Error 0.09
|
-0.60 mmol/L
Standard Error 0.09
|
-0.46 mmol/L
Standard Error 0.09
|
-0.30 mmol/L
Standard Error 0.09
|
PRIMARY outcome
Timeframe: Beginning and end of each phaseSerum LDL cholesterol will be estimated using the Friedewald equation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of each phaseThe rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Once for each participantThe Single Nucleotide Polymorphism (SNP) rs3808607 of CYP7A1 gene, rs429358 and rs7412 of APOE gene, and their associations with different blood lipid responses to beta-glucan interventions will be determined.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every day for body weight; beginning and end of each phase for WCBody weight will be monitored every day when subject visits the Richardson Centre. Waist circumference will be measured at the beginning and end of each study phase.
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3g HMW Beta-glucan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3g LMW Beta-glucan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
5g LMW Beta-glucan
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