Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/08/2015
Date assigned
07/09/2015
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The human gut plays host to tens of trillions of different bacteria, which are known as the “gut flora”. The bacteria present in the gut flora are often referred to as “good” or “friendly” bacteria, because they assist in digestion and help to produce important vitamins for the body. Probiotics, which usually come in the form of supplements or drinks, are live bacteria which are promoted as being extremely beneficial for health, as they are thought to replenish levels of “good bacteria” in the gut. Many studies have shown that probiotic supplements can help to support a healthy digestive and immune system. It has also been shown that probiotics can help to increase the amounts of essential nutrients, such as proteins, that are absorbed in the gut. An initial study has shown that consuming probiotics and protein together can help improve performance in athletes during resistance training (weight training). It is well established that protein can help to prevent and repair muscle damage following exercise, and this study aims to find out whether consuming protein and probiotics together can help to speed up muscle recovery and reduce muscle damage following a damaging exercise bout, as well as boosting athletic performance.

Who can participate?
Healthy men between 18 and 25 years of age, who take part in sports recreationally (not professionally).

What does the study involve?
At the start of the study, each participant is given time to get used to the different exercises that are used in the study. All participants are then asked to consume 20g casein (protein found in milk products) every day for two weeks. They then complete a bout of potentially muscle-damaging exercise. Markers of muscle damage, recovery and athletic performance are then measured at 24 hour intervals over 72 hours. After a one week break, participants then consume 20g casein as well as the pro-biotic (GanedenBC30) every day for two weeks, after which the exercises and measurements are repeated, at 24 hour intervals over 72 hours.

What are the possible benefits and risks of participating?
A benefit of participating is that the results of this study will provide athletes with a nutritional alternative to reduce the negative effects of training. Possible risks include pain during the collection of the blood sample and injury during the exercise.

Where is the study run from?
Department of Health Sciences and Human Performance, University of Tampa, Florida (USA)

When is the study starting and how long is it expected to run for?
July 2014 to May 2015

Who is funding the study?
Ganeden Biotech Inc. (USA)

Who is the main contact?
Dr Ralf Jaeger

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ralf Jaeger

ORCID ID

Contact details

2138 E Lafayette Pl
Milwaukee
53202
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Increnovo 14-12 [BC30 Sports]

Study information

Scientific title

Effects of co-administration of probiotic (Bacillus coagulans GBI-30, 6086) and protein (Casein) on markers of skeletal muscle damage, perceived recovery and athletic performance after an intense single leg training bout

Acronym

Study hypothesis

To determine if the co-administration of GanedenBC30 with protein has a beneficial effect on muscle damage, recovery and athletic performance following a damaging exercise bout.

Ethics approval

The University of Florida Tampa institutional review board committee, 21/08/2014, ref: 18-25

Study design

Single-blind diet-controlled single-center crossover study.

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Probiotic supplementation

Intervention

Healthy, recreationally trained male athletes consume 20g of casein (Control = CON) for 2 weeks (days 1-14), followed by a muscle-damaging exercise bout on day 15, perceptual measures on day 16 (24 hours post exercise), perceptual, muscle damage and performance measures on day 17 (48 hours post exercise), and perceptual measures on day 18 (72 hours post exercise). Following a one-week wash-out period (days 19-24), the athletes consume 20g of casein plus 1 billion CFU Bacillus coagulans GBI-30, 6086 (GanedenBC30; Ganeden Biotech Inc., Maryfield Heights, OH) for two weeks (days 25-38). A muscle-damaging exercise bout is then performed on day 39, perceptual measures on day 40 (24 hours post exercise), perceptual, muscle damage and performance measures on day 41 (48 hours post exercise), and perceptual measures on day 42 (72 hours post exercise). Both supplemental conditions are identical in appearance, taste, and weight.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Perceptual measures of recovery [muscle soreness and perceived recovery] will be assessed using the visual analogue scale [VAS].
2. Markers of muscle damage determined:
2.1. Blood Creatine Kinase (CK)
2.2. Blood Urea Nitrogen (BUN)
2.3. Muscle Swelling (MS) will be assessed via two-dimensional, B-mode ultrasonography (GE, LoGIQ e) to determine muscle thickness of the vastus lateralis (VL)
3. Athletic Performance:
3.1. Single-Leg 1RM (1RM): will be assessed via one repetition maximum testing (1RM) in the one-legged leg press. Three maximal attempts will be allotted with the greatest 1 RM counting for final data.
3.2. Single-Leg Vertical Jump Peak Power (VJPP): will be assessed via maximal vertical jump peak power bout using a Tendo Unit (Trencin, Slovak Republic). Three maximal attempts will be allotted with the greatest peak power counting for final data. Participants will 60 seconds between vertical jump attempts.
3.3. Wingate Peak Power (WPP): will be assessed via Monark Wingate cycle ergometry (Monark™, Vansbro, Sweden). During the cycling test, the volunteer will be instructed to cycle against a predetermined resistance (7.5% of body mass) as fast as possible for 10 seconds.

Secondary outcome measures

N/A

Overall trial start date

01/07/2014

Overall trial end date

09/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Normal, healthy individuals
2. Aged between 18-25 years
3. Recreationally Trained Males
4. Must be able to perform required testing

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

38

Participant exclusion criteria

1. Subjects consuming any ergogenic sports nutrition supplements (incl. creatine, HMB, PA, ATP, carnitine or beta-alanine) at least 4 weeks prior to the beginning of the study.
2. Use of prescription medications (antibiotics, NSAIDs)
3. Use of probiotics or digestive enzymes
4. Smokers
5. Presence of any musculoskeletal, medical, or metabolic contraindications.

Recruitment start date

23/02/2015

Recruitment end date

16/03/2015

Locations

Countries of recruitment

United States of America

Trial participating centre

Department of Health Sciences and Human Performance
The University of Tampa 401 W. Kennedy Blvd.
Tampa, Florida
33606
United States of America

Sponsor information

Organisation

Ganeden Biotech Inc.

Sponsor details

Suite 300
5800 Landerbrook Drive
Mayfield Heights
44124
United States of America

Sponsor type

Industry

Website

www.ganedenprobiotics.com

Funders

Funder type

Industry

Funder name

Ganeden Biotech Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plans to submit a publication to a peer-reviewed scientific journal in September 2015.

Intention to publish date

31/03/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes