NCT04330209

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

3 years

First QC Date

March 27, 2020

Last Update Submit

April 6, 2020

Conditions

Weight LossGlucose, High BloodLDL HyperlipoproteinemiaHDLTriglycerides High

Keywords

Glycaemic indexnutrigeneticsweight lossketogenicnutrigenomics

Outcome Measures

Primary Outcomes (2)

  • Weight loss - kg and BMI

    Weight loss after 6 months diet

    6 months

  • Weight loss - kg and BMI

    After 18-months follow up on normal nutrition

    18 months

Secondary Outcomes (6)

  • Blood glucose

    6 months

  • Blood glucose

    18 months

  • Cholesterol

    6 months

  • Cholesterol

    18 months

  • Triglycerides

    6 months

  • +1 more secondary outcomes

Study Arms (2)

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.

Other: weight loss diets

Ketogenic

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

Other: weight loss diets

Interventions

weight loss dietsOTHER

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

KetogenicLowGI/nutrigenetic

Eligibility Criteria

Age24 Years - 56 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Obese (BMI ≥30)
  • Age ≥ 18 years
  • Male or female
  • Smoking or not smoking

You may not qualify if:

  • Type 1 diabetes
  • Type 2 diabetes
  • Any other disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32983551DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

buccal swab for DNA, venous blood for cholesterol \& glucose

MeSH Terms

Conditions

Weight LossHypertriglyceridemia

Interventions

Diet, Reducing

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Research Fellow

Study Record Dates

First Submitted

March 27, 2020

First Posted

April 1, 2020

Study Start

January 1, 2014

Primary Completion

December 31, 2016

Study Completion

June 1, 2017

Last Updated

April 8, 2020

Record last verified: 2020-04