Impact of glucosamine supplementation on gut health
| ISRCTN | ISRCTN28637234 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28637234 |
| Secondary identifying numbers | INC-LINU-2018-12 |
- Submission date
- 04/06/2021
- Registration date
- 08/06/2021
- Last edited
- 06/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study arms
Glucosamine (GLU) is a natural compound found in cartilage and supplementation with glucosamine has been shown to improve joint health and has been linked to reduced mortality rates. GLU is poorly absorbed and may exhibit functional properties in the gut. The purpose of this study was to examine the impact of glucosamine on gastrointestinal function as well as changes in fecal microbiota and metabolome (bacteria present in the gut and in feces).
Who can participate?
Healthy male and females subjects between the ages of 18 - 50 years
What does the study involve?
Participants were randomly allocated to receive supplementation with glucosamine or placebo daily for 21 days. After 3 weeks break, the participants then received the opposite allocation for a further 21 days. Collection of stool samples 4 times during the study.
What are the possible benefits and risks of participating?
Improved gut health, no risks
Where is the study run from?
Lindenwood University (USA)
When is the study starting and how long is it expected to run for?
April 2018 to September 2019
Who is funding the study?
TSI Group Ltd., Missoula, MT, USA
Who is the main contact?
Dr Chad M. Kerksick, ckerksick@lindendwood.edu
Contact information
Scientific
209 S Kingshighway St
St Charles, MO
63301
United States of America
 ORCID ID |
0000-0003-0458-7294 |
|---|---|
| Phone | +1 636.627.4629 |
| ckerksick@lindenwood.edu |
Study information
| Study design | Interventional double-blind randomized crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Impact of glucosamine supplementation on gut health, microbiota and metabolome |
| Study acronym | GluGutHealth |
| Study hypothesis | Glucosamine (GLU) is a natural compound found in cartilage and supplementation with glucosamine has been shown to improve joint heath and has been linked to reduced mortality rates. GLU is poorly absorbed and may exhibit functional properties in the gut. The purpose of this study was to examine the impact of glucosamine on gastrointestinal function as well as changes in fecal microbiota and metabolome. |
| Ethics approval(s) | Approved 18/10/2018, Lindenwood University Institutional Review Board (IRB) (209 South Kingshighway, Library and Academic Resources Center Room 243, St. Charles, MO USA 63301; +1-636-949-4730; irb@lindenwood.edu), ref: # IRB-19-8, |
| Condition | Impact of glucosamine supplementation on gut health in healthy subjects |
| Intervention | On a daily basis, participants were instructed to ingest 3,000 mg of Glucosamine Hydrochloride (GlucosaGreen® TSI Group Ltd. MT, USA) or a matching placebo (maltodextrin), identical in appearance for a total of 21 days. Following a three week washout period participant ingested the other supplement for 21 days. Randomization was completed online (Random.org). |
| Intervention type | Supplement |
| Primary outcome measure | 1. Fecal metabolome (short-chain fatty acids, amino acids, amino acid breakdown products, nucleotide breakdown products, microbially produced fermentation products, likely diet-derived products) is measured using stool samples at baseline, after 3 weeks of supplementation, after 3 weeks of washout, after 3 weeks of supplementation 2. Fecal Microbiota is measured using stool samples at baseline, after 3 weeks of supplementation, after 3 weeks of washout, after 3 weeks of supplementation and analyzed for microbiota diversity, bacterial taxa) 3. Stool consistency will be analyzed via the Bristol Stool Chart at baseline, after 3 weeks of supplementation, after 3 weeks of washout, after 3 weeks of supplementation 4. Gut health will be measured via the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire at baseline, after 3 weeks of supplementation, after 3 weeks of washout, after 3 weeks of supplementation |
| Secondary outcome measures | Safety measured using adverse event monitoring throughout the study |
| Overall study start date | 01/04/2018 |
| Overall study end date | 01/09/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 11 |
| Total final enrolment | 11 |
| Participant inclusion criteria | 1. Between the ages of 18 – 50 years 2. Body mass index between 18.5 – 27 kg/m² 3. Weight stable for the past three months (less than 5% variation in body mass) 4. Free from all cardiovascular, pulmonary, autoimmune, musculoskeletal, gastrointestinal, psychological, or other diseases or disorders, as reported in their medical history |
| Participant exclusion criteria | 1. Diagnosed with or were being treated for celiac disease, lactose intolerance, digestive insufficiencies, or other gastrointestinal complications such as irritable bowel syndrome, ulcerative colitis, etc. 2. A current smoker or had quit within the past six months 3. Currently using anabolic steroids or any illicit or recreational drugs 4. Currently taking any antibiotics, probiotics or medication known to impact study outcomes 5. Actively trying to lose weight which included participating in diets that would impact study outcomes (ketogenic or low carbohydrate diet) |
| Recruitment start date | 19/10/2018 |
| Recruitment end date | 01/12/2018 |
Locations
Countries of recruitment
- United States of America
Study participating centre
School of Health Sciences
209 S Kingshighway St
St. Charles, MO
63301
United States of America
Sponsor information
Industry
135 W Main St
Missoula, MT
59802
United States of America
| Phone | +1 (877) 549-9123 |
|---|---|
| customersupport@us.tsigroupltd.com | |
| Website | https://tsigroupltd.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-reviewed scientific journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Dr Chad M. Kerksick, ckerksick@lindendwood.edu |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/06/2021 | 06/07/2021 | Yes | No |
Editorial Notes
06/07/2021: Publication reference added.
08/06/2021: Trial's existence confirmed by Lindenwood University Institutional Review Board.
