Trial Outcomes & Findings for Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans (NCT NCT01727895)

NCT ID: NCT01727895

Last Updated: 2014-07-31

Results Overview

The primary objective of the study is to evaluate the systemic effects of orally administered Beta-glucan on innate immune responses of leukocytes. The effects of Beta-glucan will be determined by measuring the ex vivo responsiveness of leukocytes to various inflammatory stimuli as a surrogate marker of the antimicrobial response

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: up to 21 days
• Results posted on: 2014-07-31

Participant Flow

Recruitment took place from April until May 2013 in the Radboud University Medical Centre Nijmegen.

Exclusion of subjects was based on pre-defined exclusion criteria or the unability of subjects to comply with the study time schedule.

Participant milestones

Measure	Beta-glucan Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days. Beta-glucan (Glucan #300®)	Control Group No intervention
Overall Study STARTED	10	5
Overall Study COMPLETED	10	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans

Baseline characteristics by cohort

Measure	Beta-glucan n=10 Participants Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days. Beta-glucan (Glucan #300®)	Control Group n=5 Participants No intervention	Total n=15 Participants Total of all reporting groups
Age, Continuous	20 years n=93 Participants	20 years n=4 Participants	20 years n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	5 Participants n=4 Participants	15 Participants n=27 Participants
TNF-α Secretion by ex Vivo LPS-Stimulated Peripheral Blood mononuclear cells	691 pg/ml n=93 Participants	749 pg/ml n=4 Participants	720 pg/ml n=27 Participants

PRIMARY outcome

Timeframe: up to 21 days

The primary objective of the study is to evaluate the systemic effects of orally administered Beta-glucan on innate immune responses of leukocytes. The effects of Beta-glucan will be determined by measuring the ex vivo responsiveness of leukocytes to various inflammatory stimuli as a surrogate marker of the antimicrobial response

Outcome measures

Measure	Beta-glucan n=10 Participants Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days. Beta-glucan (Glucan #300®)	Control Group n=5 Participants No intervention
Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)	691 pg/ml Interval 276.0 to 2649.0	749 pg/ml Interval 287.0 to 1160.0

SECONDARY outcome

Timeframe: days 0, 6, 21

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 0, 6, 21

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 0, 6, 21

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 0, 6, 21

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 0, 6, 21

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 0, 6, 21

Outcome measures

Outcome data not reported

Adverse Events

Beta-glucan

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Beta-glucan n=10 participants at risk Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days. Beta-glucan (Glucan #300®)	Control Group n=5 participants at risk No intervention
Skin and subcutaneous tissue disorders Flare of acne, one week after discontinuation of Beta-glucan intake	10.0% 1/10 • Number of events 1	0.00% 0/5

Additional Information

Drs. Jenneke Leentjens

Radboud UMC

Phone: 0031-243668420

Email: Jenneke.Leentjens@radboudumc.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place