- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04330209
Comparing a Low-GI Nutrigenetic and Ketogenic Diet for Weight Loss With 18 Month Follow-up (LOWGI_GENE)
Study Overview
Status
Intervention / Treatment
Detailed Description
In the present study, the investigators followed patients in a clinic who self-selected either a ketogenic diet with no nutrigenetic modification, or a low glycemic index (GI) based diet with nutrigenetic modifications. The addition of nutrigenetic advice was not designed nor proposed to patients as a weight loss diet, nor to predict either disease risk or obesity risk; the aim was simply to optimize the nutrient content of an individual's daily food intake, based on current understanding of an individual's genetic profile. The aim of this study, therefore, was to compare the performance of the well-known, and generally the most effective in the short-term [25], ketogenic diet to a low-GI nutrigenetic diet. A ketogenic diet has also shown to have long-term (12 months) effectiveness for weight loss [26], although the effects of the diet over a longer time period than this are currently unclear.
114 overweight (n=1) and obese (n=113) subjects (M = 55, F = 59, age 24-56y, all of Romanian heritage and similar socio-economic status), who were patients at a weight management clinic (Bucharest, Romania), gave written informed consent for their weight loss data to be prospectively analysed for this study. All patient data were handled according to the Romanian Code of Medical Deontology and in accordance with the Helsinki Agreement. Approval was given by the Ethics Committee of the University and Pharmacy, Cluj Napoca, Romania (registration number 444). Upon enrolment at the weight management clinic, the subjects self-selected either a ketogenic diet or a low-GI nutrigenetic diet. A ketogenic diet was utilised as the comparison diet due to its reported efficacy in the treatment of obesity [26]. Fifty-three subjects (25 female; age 43.0 ± 7.2y) selected the ketogenic diet plan, and 61 subjects (34 female; age 42.0 ± 6.7y) selected the low-GI nutrigenetic diet plan. Subjects in the low-GI nutrigenetic diet group underwent DNA testing (NutriGENE by Eurogenetica Ltd/DNAfit, UK) for 28 Single Nucleotide Polymorphisms (SNPs) in 22 genes with good evidence of gene-diet/lifestyle interactions [table 1]. Overall participation in both diet groups cost a similar amount, comprised of approximately €300 for the genetic test along with 1-month diet plan, initial evaluation, body composition, and medical history for the nutrigenetic group, and €280 for the ketogenic group, providing Ketostix and the same evaluations. Further visits through the 24-week program the overall cost per patient was approximately €800. After 24 weeks diet follow up visits had no further cost.
After the 24-week study period, the subjects were monitored for an additional 18 months.
At the study onset, patients were not type 1 or type 2 diabetics, although many were hyperglycemic, which is a common issue in obese subjects. Any patients with records of any other disease were excluded prior to commencing the dietary intervention. The patients, apart from obesity, were otherwise "healthy".
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
LowGI/nutrigenetic
114 overweight (n=1) and obese (n=113) subjects (M = 55, F = 59, age 24-56y, all of Romanian heritage and similar socio-economic status), who were patients at a weight management clinic (Bucharest, Romania), gave written informed consent for their weight loss data to be prospectively analysed for this study. Upon enrolment at the weight management clinic, the subjects self-selected either a ketogenic diet or a low-GI nutrigenetic diet. 61 subjects (34 female; age 42.0 ± 6.7y) selected the low-GI nutrigenetic diet plan. |
The ketogenic diet group were instructed to consume <35g of carbohydrates per day, and <10% of total calories were from saturated fats.
Daily protein intake was set at 1.2g/kg bodyweight for females, and 1.5g/kg bodyweight for males.
The low-GI nutrigenetic diet group had individualised dietary instructions based on their genetic results
|
Ketogenic
As above + Fifty-three subjects (25 female; age 43.0 ± 7.2y) selected the ketogenic diet plan
|
The ketogenic diet group were instructed to consume <35g of carbohydrates per day, and <10% of total calories were from saturated fats.
Daily protein intake was set at 1.2g/kg bodyweight for females, and 1.5g/kg bodyweight for males.
The low-GI nutrigenetic diet group had individualised dietary instructions based on their genetic results
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight loss - kg and BMI
Time Frame: 6 months
|
Weight loss after 6 months diet
|
6 months
|
Weight loss - kg and BMI
Time Frame: 18 months
|
After 18-months follow up on normal nutrition
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose
Time Frame: 6 months
|
Levels of blood glucose
|
6 months
|
Blood glucose
Time Frame: 18 months
|
Levels of blood glucose
|
18 months
|
Cholesterol
Time Frame: 6 months
|
Levels of LDL and LDL
|
6 months
|
Cholesterol
Time Frame: 18 months
|
Levels of LDL and LDL
|
18 months
|
Triglycerides
Time Frame: 6 months
|
Levels of blood triglycerides
|
6 months
|
Triglycerides
Time Frame: 18 months
|
Levels of blood triglycerides
|
18 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOWGI_GENE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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