Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 34 of 54 for:    barley

Effect of Beta-Glucan on Cholesterol Lowering

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01408719
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : March 11, 2014
Last Update Posted : November 5, 2015
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Dr. Nancy Ames, University of Manitoba

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Hypercholesterolemia
Interventions Dietary Supplement: Control
Dietary Supplement: 3g LMW beta-glucan
Dietary Supplement: 5g LMW beta-glucan
Dietary Supplement: 3g HMW beta-glucan
Enrollment 45
Recruitment Details Participants were recruited at the Richardson Centre for Functionals Foods and Nutraceuticals, University of Manitoba, Winnipeg during July 2010 to May 2011
Pre-assignment Details Over 200 subjects were screened; 45 subjects were enrolled in the study and randomly assigned to the experimental diets (treatment groups).
Arm/Group Title Sequence 1 Sequence 2 Sequence 3 Sequence 4 Sequence 5 Sequence 6 Sequence 7 Sequence 8 Sequence 9 Sequence 10 Sequence 11 Sequence 12 Sequence 13 Sequence 14 Sequence 15 Sequence 16 Sequence 17 Sequence 18 Sequence 19 Sequence 20
Hide Arm/Group Description 3g LMW followed by control, followed by 3g HMW, followed by 5g LMW Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW 3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control 5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control 3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW 5g LMW, followed by 3g LMW, followed control, followed by 3g HMW 3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW 3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW 5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW 3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW 3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control 3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW 3g HMW, followed by 5g LMW, followed 3g LMW, followed by control 3g HMW, followed by 3g LMW, followed 5g LMW, followed by control 5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW 3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
Period Title: 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
Completed 2 3 1 2 3 3 2 3 1 1 2 2 2 4 1 2 2 2 0 1
Not Completed 0 0 1 0 1 0 0 0 1 0 0 0 0 1 0 0 1 0 1 0
Period Title: Washout Period (28 Days)
Started 2 3 1 2 3 3 2 3 1 1 2 2 2 4 1 2 2 2 0 1
Completed 2 3 1 2 3 3 2 3 1 1 2 2 2 4 1 2 2 2 0 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: 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
Completed 2 3 1 2 3 3 2 3 1 1 2 2 2 3 1 2 2 2 0 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0
Period Title: Washout Period (28 Days)
Started 2 3 1 2 3 3 2 3 1 1 2 2 2 3 1 1 2 2 0 1
Completed 2 3 1 2 3 3 2 3 1 1 2 2 2 3 1 1 2 2 0 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: 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
Completed 2 3 1 2 3 3 2 2 1 1 2 2 2 3 1 1 2 2 0 1
Not Completed 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: 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
Completed 2 3 1 2 3 3 2 2 1 1 2 2 1 3 1 1 2 2 0 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: 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
Completed 2 3 1 2 3 3 2 2 1 1 2 2 1 3 1 1 2 2 0 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Sequence 1 Sequence 2 Sequence 3 Sequence 4 Sequence 5 Sequence 6 Sequence 7 Sequence 8 Sequence 9 Sequence 10 Sequence 11 Sequence 12 Sequence 13 Sequence 14 Sequence 15 Sequence 16 Sequence 17 Sequence 18 Sequence 19 Sequence 20 Total
Hide Arm/Group Description 3g LMW followed by control, followed by 3g HMW, followed by 5g LMW Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW 3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control 5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control 3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW 5g LMW, followed by 3g LMW, followed control, followed by 3g HMW 3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW 3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW 5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW 3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW 3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control 3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW 3g HMW, followed by 5g LMW, followed 3g LMW, followed by control 3g HMW, followed by 3g LMW, followed 5g LMW, followed by control 5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW 3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW Total of all reporting groups
Overall Number of Baseline Participants 2 3 1 2 3 3 2 2 1 1 2 2 1 3 1 1 2 1 1 1 35
Hide Baseline Analysis Population Description
It is a cross over trial so the total number of participants is same throughout the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 1 participants 2 participants 3 participants 3 participants 2 participants 2 participants 1 participants 1 participants 2 participants 2 participants 1 participants 3 participants 1 participants 1 participants 2 participants 1 participants 1 participants 1 participants 35 participants
46  (15.6) 52.7  (3.5) 40  (0) 63  (1.4) 70  (10.6) 55  (14) 55.5  (2.12) 67  (1.4) 57  (0) 27  (0) 62.5  (0.7) 59.5  (4.9) 62  (0) 59.3  (3.8) 76  (0) 58  (0) 53  (8.5) 59  (0) 65  (0) 59  (0) 57.9  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 1 participants 2 participants 3 participants 3 participants 2 participants 2 participants 1 participants 1 participants 2 participants 2 participants 1 participants 3 participants 1 participants 1 participants 2 participants 1 participants 1 participants 1 participants 35 participants
Female
2
 100.0%
1
  33.3%
1
 100.0%
2
 100.0%
1
  33.3%
2
  66.7%
2
 100.0%
0
   0.0%
1
 100.0%
0
   0.0%
2
 100.0%
1
  50.0%
0
   0.0%
3
 100.0%
1
 100.0%
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
20
  57.1%
Male
0
   0.0%
2
  66.7%
0
   0.0%
0
   0.0%
2
  66.7%
1
  33.3%
0
   0.0%
2
 100.0%
0
   0.0%
1
 100.0%
0
   0.0%
1
  50.0%
1
 100.0%
0
   0.0%
0
   0.0%
1
 100.0%
2
 100.0%
0
   0.0%
1
 100.0%
1
 100.0%
15
  42.9%
1.Primary Outcome
Title Changs in Total Cholesterol
Hide Description Fasted total cholesterol concentration will be measured using the automated enzymatic methods.
Time Frame Beginning and end of each phase
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 5g LMW Beta Glucan 3g HMW Beta Glucan 3g LMW Beta Glucan Control
Hide Arm/Group Description:

5 gram low molecular weight barley beta-glucan diet for 35 days

Control: Minimal beta-glucan

3 gram high molecular weight barley beta-glucan diet for 35 days

3g LMW beta-glucan: 3grams beta-glucan

3 grams of low molecular weight beta-glucan diet for 35 days

5g LMW beta-glucan: 5 grams beta-glucan

control diet containing negligible amount of beta glucan

3g HMW beta-glucan: 3 grams of high molecular weight beta-glucan

Overall Number of Participants Analyzed 30 30 30 30
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.42  (0.09) -0.60  (0.09) -0.46  (0.09) -0.30  (0.09)
2.Primary Outcome
Title Changes in LDL Cholesterol
Hide Description Serum LDL cholesterol will be estimated using the Friedewald equation.
Time Frame Beginning and end of each phase
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Cholesterol Absorption/Synthesis
Hide Description The rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique.
Time Frame End of each phase
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Potential Gene-nutrient Interactions: CYP7A1 and APOE
Hide Description The 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.
Time Frame Once for each participant
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Changes in Body Weight and Waist Circumference(WC)
Hide Description Body 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.
Time Frame Every day for body weight; beginning and end of each phase for WC
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control 3g HMW Beta-glucan 3g LMW Beta-glucan 5g LMW Beta-glucan
Hide Arm/Group Description Minimal barley and minimal beta-glucan 3 grams high molecular weight barley beta-glucan 3 grams low molecular weight barley beta-glucan 5 grams low molecular weight barley beta-glucan
All-Cause Mortality
Control 3g HMW Beta-glucan 3g LMW Beta-glucan 5g LMW Beta-glucan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control 3g HMW Beta-glucan 3g LMW Beta-glucan 5g LMW Beta-glucan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control 3g HMW Beta-glucan 3g LMW Beta-glucan 5g LMW Beta-glucan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Nancy Ames
Organization: Agriculture and Agri-food Canada
Phone: 204-474-7187
Responsible Party: Dr. Nancy Ames, University of Manitoba
ClinicalTrials.gov Identifier: NCT01408719     History of Changes
Other Study ID Numbers: B2010:216
First Submitted: August 2, 2011
First Posted: August 3, 2011
Results First Submitted: August 12, 2013
Results First Posted: March 11, 2014
Last Update Posted: November 5, 2015