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

NCT ID: NCT04330209

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2017-06-01

Brief Summary

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.

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".

Conditions

Weight Loss; Glucose, High Blood; LDL Hyperlipoproteinemia; HDL; Triglycerides High

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

weight loss diets

Intervention Type: 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

Ketogenic

As above + Fifty-three subjects (25 female; age 43.0 ± 7.2y) selected the ketogenic diet plan

weight loss diets

Intervention Type: 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

Interventions

weight loss diets

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 56 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Keith Anthony Grimaldi

Honorary Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Vranceanu M, Pickering C, Filip L, Pralea IE, Sundaram S, Al-Saleh A, Popa DS, Grimaldi KA. A comparison of a ketogenic diet with a LowGI/nutrigenetic diet over 6 months for weight loss and 18-month follow-up. BMC Nutr. 2020 Sep 24;6:53. doi: 10.1186/s40795-020-00370-7. eCollection 2020.

Reference Type: DERIVED

PMID: 32983551 (View on PubMed)

Other Identifiers

LOWGI_GENE

Identifier Type: -

Identifier Source: org_study_id