Weight Loss Clinical Trial
— LOWGI_GENEOfficial title:
Comparing a Low-GI Nutrigenetic and Ketogenic Diet for Weight Loss With 18 Month Follow-up
NCT number | NCT04330209 |
Other study ID # | LOWGI_GENE |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2014 |
Est. completion date | June 1, 2017 |
Verified date | April 2020 |
Source | Iuliu Hatieganu University of Medicine and Pharmacy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators followed a convenience sample of 114 overweight and obese subjects from a weight loss clinic who followed a 24-week dietary intervention. The subjects self-selected whether to follow a standardized ketogenic diet (n=53), or a personalised low-glycemic index (GI) diet utilising information from 28 single nucleotide polymorphisms (n=61). After the 24-week study period, the subjects were monitored for an additional 18 months.
Status | Completed |
Enrollment | 114 |
Est. completion date | June 1, 2017 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Years to 56 Years |
Eligibility |
Inclusion Criteria: - Obese (BMI =30) - Age = 18 years - Male or female - Smoking or not smoking Exclusion Criteria: - Type 1 diabetes - Type 2 diabetes - Any other disease |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Iuliu Hatieganu University of Medicine and Pharmacy |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight loss - kg and BMI | Weight loss after 6 months diet | 6 months | |
Primary | Weight loss - kg and BMI | After 18-months follow up on normal nutrition | 18 months | |
Secondary | Blood glucose | Levels of blood glucose | 6 months | |
Secondary | Blood glucose | Levels of blood glucose | 18 months | |
Secondary | Cholesterol | Levels of LDL and LDL | 6 months | |
Secondary | Cholesterol | Levels of LDL and LDL | 18 months | |
Secondary | Triglycerides | Levels of blood triglycerides | 6 months | |
Secondary | Triglycerides | Levels of blood triglycerides | 18 months |
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