Condition category
Not Applicable
Date applied
13/09/2018
Date assigned
03/10/2018
Last edited
03/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
AmLexin is a supplement with claims that it can keep joints healthy, protect joints from stress, support heart and joint health, keep bodies going strong and help people to bounce back from physical challenges. This study aims to show that AmLexin can support these claims through recruiting healthy people to take AmLexin whilst training for and completing a half-marathon, along with look at its effects on pain, stiffness, range of motion, mood and cellular oxidation.

Who can participate?
People aged 18-70 years old who are healthy and active and have the ability to train for and complete a half-marathon

What does the study involve?
Participants will be randomly allocated to one of two groups. One group will be given AmLexin to take twice daily for 8 weeks, whereas the other will be given a placebo to take twice daily for 8 weeks. During these 8 weeks, both groups will undergo training for a half-marathon. There will be a minimum of 3 training sessions per week (1 hour per session), with increasing difficulty. These sessions will focus on hill, interval and distance training. After completing the half-marathon, participants in both groups will be asked to take their supplement (AmLexin or placebo) for one more week.


What are the benefits and risks of participating?
Participants may or may not benefit from taking part in this study, depending on the effect of AmLexin on themselves. Participants may face a risk of temporary gastrointestinal discomfort associated with consuming an unfamiliar dietary supplement. Although each of the ingredients found in the supplement has been documented to be extremely safe, there is some possibility that participants, or an unborn child, may be subject to risks that have not been identified. There is a possibility of an allergic reaction to the nutritional supplement or placebo. Symptoms of allergy include rash, wheezing or difficulty breathing or swallowing, dizziness, swelling of the mouth, hands or eyes, a fast heart rate and sweating. Participants may experience muscle stiffness, pain and or injuries relating to the exercise program.


Where is the study run from?
1. Treehouse Athletic Club, Draper, UT (USA)
2. GLH Nutrition, LLC, Draper, UT (USA)

When is the study starting and how long is it expected to run for?
April 2017 to April 2018

Who is funding the study?
Unigen Inc. (USA)

Who is the main contact?
Lidia A Brownell
lbrownell@unigen.net

Trial website

Contact information

Type

Scientific

Primary contact

Ms Lidia Alfaro Brownell

ORCID ID

Contact details

2121 South State Street
Tacoma
98405
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UNI1306-2

Study information

Scientific title

Effects of AmLexin (Acacia Catechu and Morus Alba) on Redox and Subjective Pain in Healthy Physically Active Adults

Acronym

Study hypothesis

To investigate the use of a dietary herbal supplement on healthy active subjects on measures of pain, stiffness, range of motion, psychological mood state and cellular oxidation.

Ethics approval

Aspireirb A WIRB Copernicus Group, 02/05/2017, Unigen2017

Study design

Interventional randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Pain, stiffness, range of motion, psychological mood state (wellbeing, mood, vigor) and cellular oxidation

Intervention

30 participants will be randomly allocated to the active group or the placebo group. This study is a double-blind study.
Participants in the active group will receive 400 mg AmLexin (Acacia catechu heartwood and Morus alba root) - 200 mg will be taken twice daily (once in the morning and once in the evening) for 8 weeks. Participants in the placebo group will be given a matched placebo containing white rice flour and starch, again to be taken once in the morning and once in the evening daily for 8 weeks.
During this 8 week period, participants will take part in a training program for a half-marathon run (13.1 miles). This will involve a minimum of 3 specific training runs of approximately 1 hour duration, with progressively higher intensity and duration each week. This includes at least one "hill" workout, one "interval" workout and one "distance" workout.
After completing the half-marathon run, participants in both groups will be asked to continue taking their allocated supplements for one week.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

The following are assessed at the baseline, weekly during the training regimen (weeks 1, 2, 3, 4, 5, 6, 7 and 8), and daily for a week post half-marathon:
1. Range of motions (ROM), assessed using digital inclinometry
2. Pain, stiffness and activities of daily living, assessed using a visual analogue scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)


Secondary outcome measures

1. Oxidation-reduction potential (ORP), assessed using the Luoxis' proprietary RedoxSYS Diagnostic System at the baseline and 7 days post-marathon
2. Profile of mood states, assessed using the Profile of Mood States Survey (POMS) at the baseline and 1 and 7 days post-marathon

Overall trial start date

24/04/2017

Overall trial end date

23/04/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18-70
2. BMI < 30 kg/m²
3. Healthy and active
4. No recurrent pain or limitations in range of motion
5. Ability to complete training for, and complete, a 13.1 mile half-marathon run
6. Willing to consume dietary supplements under investigation
7. Willing to undertake all protocol measurements and training regimens
8. Ability to understand and sign the informed consent form

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Recurrent pain, use of pain medications or pain supplements
2. Pregnant or breastfeeding women
3. Inability to complete prescribed training regimen
4. Current use of other pain support supplement or over-the-counter drug

Recruitment start date

22/07/2017

Recruitment end date

18/08/2017

Locations

Countries of recruitment

United States of America

Trial participating centre

EQQIL/ GLH Nutrition
648 E. Rocky Knoll Lane
Draper
84020
United States of America

Trial participating centre

Treehouse Athletic Club
1101 East Draper Parkway
Draper
84020
United States of America

Sponsor information

Organisation

Unigen Inc.

Sponsor details

2121 south State Street
Suite 400
Tacoma
98405
United States of America

Sponsor type

Other

Website

www.unigent.net

Funders

Funder type

Not defined

Funder name

Unigen Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal in 2018

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Lidia A Brownell (lbrownell@unigen.net)

Intention to publish date

04/11/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes