The effect of a novel polysaccharide blend (PGX® micro-granules) on short- term weight loss and other laboratory parameters in overweight and obese adults: an observational retrospective analysis
| ISRCTN | ISRCTN50749194 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50749194 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/04/2007
- Registration date
- 16/10/2007
- Last edited
- 19/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Lyon, MD
Scientific
Scientific
1550 United Blvd.
Coquitlqam
V3K 6Y7
Canada
| Phone | +1 604 777 5500 |
|---|---|
| info@functionalmedicine.ca |
Study information
| Study design | An observational retrospective program design. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Other |
| Study setting(s) | Other |
| Study type | Quality of life |
| Scientific title | The effect of a novel polysaccharide blend (PGX® micro-granules) on short- term weight loss and other laboratory parameters in overweight and obese adults: an observational retrospective analysis |
| Study objectives | The purpose of this observational retrospective analysis is to examine the efficacy of PGX® micro-granules on weight loss, body mass index, waist circumference, waist-hip ratio, plus laboratory measurements including total and Low Density Lipoprotein (LDL) cholesterol, triglycerides, fasting insulin, fasting glucose and two hour glucose tolerance test for 14 weeks in overweight and obese adults enrolled in a voluntary community weight loss program. |
| Ethics approval(s) | A research ethics review was not performed on this project as this was not intended to be a study at the outset. These were patients we worked with in the course of our clinical practice. After the weight loss clinical program, we performed a retrospective analysis of clinical outcomes. |
| Health condition(s) or problem(s) studied | Overweight/obesity |
| Intervention | Subjects gave their written consent for participation in the program and were required to attend group lectures on general health, diet, and exercise, every two weeks given by Dr Lyon for a 14 week period. During the 14 week program, volunteers were required to take up to 10 grams of PGX® micro-granules with 12 to 16 oz of water in divided doses throughout the day. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | PGX® micro-granules |
| Primary outcome measure | Primary outcomes measured for all participants are weight (pounds), waist and hip circumference, and percent body fat. Percent body fat was determined using bioelectrical impedance testing at baseline and every two weeks thereafter. |
| Secondary outcome measures | All subjects enrolled in the program were initially evaluated for High Density Lipoprotein (HDL), LDL, total cholesterol, triglycerides, fasting glucose, fasting insulin, two hour fasting insulin, and 75 gram glucose tolerance test at baseline, only those with aberrant risk factors were re-tested using the latter laboratory parameters at week 14. |
| Overall study start date | 01/06/2005 |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 29 |
| Total final enrolment | 29 |
| Key inclusion criteria | 1. 20 to 65 year of age 2. Body mass index range of approximately 23 kg/m^2 to 35 kg/m^2 3. Otherwise healthy |
| Key exclusion criteria | 1. Morbid obesity 2. Major psychiatric diagnosis 3. Use of other weight loss medications such as sibutramine or ephedra |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
1550 United Blvd.
Coquitlqam
V3K 6Y7
Canada
V3K 6Y7
Canada
Sponsor information
Factors Group of Nutritional Companies Inc. (Canada)
Industry
Industry
1-3655 Bonneville Place
Burnaby
V3N 4S9
Canada
| Website | http://www.naturalfactors.com/index.asp |
|---|
Funders
Funder type
Industry
Factors Group of Nutritional Companies Inc. (Canada) - continuing education grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/07/2021 | Yes | No |
Editorial Notes
19/07/2021: Publication reference and total final enrolment.
