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Completed

NCT Number: NCT04330209

Comparing a Low-GI Nutrigenetic and Ketogenic Diet for Weight Loss With 18 Month Follow-up

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.

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Key information

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

weight loss diets

Other

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

Primary outcomes

  1. Weight loss - kg and BMI

    Time frame: 6 months

    Weight loss after 6 months diet

  2. Weight loss - kg and BMI

    Time frame: 18 months

    After 18-months follow up on normal nutrition

Secondary outcomes

  1. Blood glucose

    Time frame: 6 months

    Levels of blood glucose

  2. Blood glucose

    Time frame: 18 months

    Levels of blood glucose

  3. Cholesterol

    Time frame: 6 months

    Levels of LDL and LDL

  4. Cholesterol

    Time frame: 18 months

    Levels of LDL and LDL

  5. Triglycerides

    Time frame: 6 months

    Levels of blood triglycerides

  6. Triglycerides

    Time frame: 18 months

    Levels of blood triglycerides

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Registry information

Acronym: LOWGI_GENE

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 1, 2020
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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