Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/04/2007
Date assigned
16/10/2007
Last edited
16/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Lyon, MD

ORCID ID

Contact details

1550 United Blvd.
Coquitlqam
V3K 6Y7
Canada
+1 604 777 5500
info@functionalmedicine.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

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.

Study design

An observational retrospective program design.

Primary study design

Observational

Secondary study design

Other

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

PGX® micro-granules

Primary outcome measures

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 trial start date

01/06/2005

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

29

Participant exclusion criteria

1. Morbid obesity
2. Major psychiatric diagnosis
3. Use of other weight loss medications such as sibutramine or ephedra

Recruitment start date

01/06/2005

Recruitment end date

30/09/2005

Locations

Countries of recruitment

Canada

Trial participating centre

1550 United Blvd.
Coquitlqam
V3K 6Y7
Canada

Sponsor information

Organisation

Factors Group of Nutritional Companies Inc. (Canada)

Sponsor details

1-3655 Bonneville Place
Burnaby
V3N 4S9
Canada

Sponsor type

Industry

Website

http://www.naturalfactors.com/index.asp

Funders

Funder type

Industry

Funder name

Factors Group of Nutritional Companies Inc. (Canada) - continuing education grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes