Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 85 of 228 for:    yeast

Selenium and Immune Function

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: NCT00279812
Recruitment Status : Completed
First Posted : January 20, 2006
Results First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Food Standards Agency, United Kingdom
Information provided by (Responsible Party):
Quadram Institute Bioscience

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Other
Condition Healthy
Interventions Dietary Supplement: 50ug selenium enriched yeast
Dietary Supplement: 100ug selenium enriched yeast
Dietary Supplement: 200ug selenium enriched yeast
Dietary Supplement: Control onion
Dietary Supplement: Enriched onion
Other: Placebo
Enrollment 133
Recruitment Details Recruitment ran from May until the following February in 2005, 2006, and 2007. Study completed in June 2008. 272 volunteers completed a screening questionnaire,182 volunteers had blood samples screened, total of 133 were recruited and 119 completed the study.
Pre-assignment Details  
Arm/Group Title Placebo 50ug Selenium Enriched Yeast 100ug Selenium Enriched Yeast 200ug Selenium Enriched Yeast Control Onion Enriched Onion
Hide Arm/Group Description

Placebo

Selenomethionine (supplement) and selenium enriched onions

Selenomethionine supplement (50ug/d Se) for 12 weeks Selenomethionine supplement (100ug/d Se) for 12 weeks Selenomethionine supplement (200ug/d Se) for 12 weeks 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
Period Title: Overall Study
Started 21 26 24 23 20 19
Completed 20 20 21 23 17 18
Not Completed 1 6 3 0 3 1
Reason Not Completed
Protocol Violation             1             1             0             0             1             0
Withdrawal by Subject             0             4             2             0             0             0
Adverse Event             0             1             1             0             2             1
Arm/Group Title Placebo 50ug Selenium Enriched Yeast 100ug Selenium Enriched Yeast 200ug Selenium Enriched Yeast Control Onion Enriched Onion Total
Hide Arm/Group Description

Placebo

Selenomethionine (supplement) and selenium enriched onions

Selenomethionine supplement (50ug/d Se) for 12 weeks Selenomethionine supplement (100ug/d Se) for 12 weeks Selenomethionine supplement (200ug/d Se) for 12 weeks 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 20 20 21 23 17 18 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 21 participants 23 participants 17 participants 18 participants 119 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
21
 100.0%
23
 100.0%
17
 100.0%
18
 100.0%
119
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 21 participants 23 participants 17 participants 18 participants 119 participants
55.8  (3.9) 56.5  (4.6) 58.4  (3.9) 56.1  (3.9) 58.2  (5.1) 57.7  (4.2) 57.12  (1.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 21 participants 23 participants 17 participants 18 participants 119 participants
Female
10
  50.0%
10
  50.0%
11
  52.4%
11
  47.8%
6
  35.3%
6
  33.3%
54
  45.4%
Male
10
  50.0%
10
  50.0%
10
  47.6%
12
  52.2%
11
  64.7%
12
  66.7%
65
  54.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 20 participants 20 participants 21 participants 23 participants 17 participants 18 participants 119 participants
20 20 21 23 17 18 119
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 20 participants 20 participants 21 participants 23 participants 17 participants 18 participants 119 participants
25  (2.7) 26.1  (3) 26.3  (3.9) 25.9  (3.8) 26.6  (4.1) 26.1  (2.4) 26  (0.54)
1.Primary Outcome
Title Cellular and Humoral Immune Response
Hide Description Total glutathione peroxidase 1 activity in platelets after supplementation
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject
Arm/Group Title Placebo 50ug Selenium Enriched Yeast 100ug Selenium Enriched Yeast 200ug Selenium Enriched Yeast Control Onion Enriched Onion
Hide Arm/Group Description:

Placebo

Selenomethionine (supplement) and selenium enriched onions

Selenomethionine supplement (50ug/d Se) for 12 weeks
Selenomethionine supplement (100ug/d Se) for 12 weeks
Selenomethionine supplement (200ug/d Se) for 12 weeks
3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
Overall Number of Participants Analyzed 20 18 21 23 17 18
Mean (Standard Deviation)
Unit of Measure: umol/min
0.29  (0.07) 0.34  (0.16) 0.34  (0.15) 0.29  (0.09) 0.35  (0.15) 0.35  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50ug Selenium Enriched Yeast, 100ug Selenium Enriched Yeast, 200ug Selenium Enriched Yeast, Control Onion, Enriched Onion
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Selenium Status
Hide Description Plasma selenium concentration after supplementation
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject
Arm/Group Title Placebo 50ug Selenium Enriched Yeast 100ug Selenium Enriched Yeast 200ug Selenium Enriched Yeast Control Onion Enriched Onion
Hide Arm/Group Description:

Placebo

Selenomethionine (supplement) and selenium enriched onions

Selenomethionine supplement (50ug/d Se) for 12 weeks
Selenomethionine supplement (100ug/d Se) for 12 weeks
Selenomethionine supplement (200ug/d Se) for 12 weeks
3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
Overall Number of Participants Analyzed 20 18 21 23 17 18
Mean (Standard Deviation)
Unit of Measure: ng/mL
93.7  (16.5) 118.3  (13.1) 152.0  (24.3) 177.4  (26.3) 94.2  (15.0) 106.0  (11.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50ug Selenium Enriched Yeast, 100ug Selenium Enriched Yeast, 200ug Selenium Enriched Yeast, Control Onion, Enriched Onion
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Selenoproteins and Se-biomarkers
Hide Description Plasma selenoprotein P after the supllementation
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject
Arm/Group Title Placebo 50ug Selenium Enriched Yeast 100ug Selenium Enriched Yeast 200ug Selenium Enriched Yeast Control Onion Enriched Onion
Hide Arm/Group Description:

Placebo

Selenomethionine (supplement) and selenium enriched onions

Selenomethionine supplement (50ug/d Se) for 12 weeks
Selenomethionine supplement (100ug/d Se) for 12 weeks
Selenomethionine supplement (200ug/d Se) for 12 weeks
3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
Overall Number of Participants Analyzed 20 18 21 23 17 18
Mean (Standard Deviation)
Unit of Measure: ug/mL
4.96  (0.86) 6.17  (0.85) 6.73  (1.01) 6.59  (0.64) 4.80  (1.03) 5.72  (0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50ug Selenium Enriched Yeast, 100ug Selenium Enriched Yeast, 200ug Selenium Enriched Yeast, Control Onion, Enriched Onion
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 50ug Selenium Enriched Yeast 100ug Selenium Enriched Yeast 200ug Selenium Enriched Yeast Control Onion Enriched Onion
Hide Arm/Group Description

Placebo

Selenomethionine (supplement) and selenium enriched onions

Selenomethionine supplement (50ug/d Se) for 12 weeks Selenomethionine supplement (100ug/d Se) for 12 weeks Selenomethionine supplement (200ug/d Se) for 12 weeks 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
All-Cause Mortality
Placebo 50ug Selenium Enriched Yeast 100ug Selenium Enriched Yeast 200ug Selenium Enriched Yeast Control Onion Enriched Onion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/26 (0.00%)      0/24 (0.00%)      0/23 (0.00%)      0/20 (0.00%)      0/19 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 50ug Selenium Enriched Yeast 100ug Selenium Enriched Yeast 200ug Selenium Enriched Yeast Control Onion Enriched Onion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/26 (0.00%)      0/24 (0.00%)      0/23 (0.00%)      0/20 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo 50ug Selenium Enriched Yeast 100ug Selenium Enriched Yeast 200ug Selenium Enriched Yeast Control Onion Enriched Onion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      1/26 (3.85%)      1/24 (4.17%)      0/23 (0.00%)      2/20 (10.00%)      1/19 (5.26%)    
General disorders             
cold symptoms *  0/21 (0.00%)  0 1/26 (3.85%)  1 1/24 (4.17%)  1 0/23 (0.00%)  0 2/20 (10.00%)  2 1/19 (5.26%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Charlotte Armah
Organization: Institute of Food Research
Phone: 01603 255 000 ext 5360
EMail: charlotte.armah@ifr.ac.uk
Layout table for additonal information
Responsible Party: Quadram Institute Bioscience
ClinicalTrials.gov Identifier: NCT00279812     History of Changes
Other Study ID Numbers: IFR02/2005
FSA 51949F ( Other Identifier: Food Standards Agency )
First Submitted: January 19, 2006
First Posted: January 20, 2006
Results First Submitted: November 9, 2015
Results First Posted: July 16, 2018
Last Update Posted: July 16, 2018