NCT03934476

Brief Summary

The aim of the study is to investigate the long-term effects of the ketogenic diet and exercise (including interactions) on health markers, exercise performance and wellbeing outcomes in sedentary overweight individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

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

September 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

February 15, 2019

Last Update Submit

January 22, 2021

Conditions

ObesityDiet Modification

Keywords

ketogenic dietcarbohydrateschronic diseasesphysical activityfatiguemoodwellbeing

Outcome Measures

Primary Outcomes (3)

  • Change in the time to exhaustion

    All study subjects will undergo the Graded Exercise Test, with measuring of the time to exhaustion in minutes.

    12 weeks (baseline + every four weeks)

  • Change in cardiorespiratory variables - oxygen consumption

    All study subjects will undergo the Graded Exercise Test, with measuring of the oxygen consumption (L/min).

    12 weeks (baseline + every four weeks)

  • Change in cardiorespiratory variables - heart rate

    All study subjects will undergo the Graded Exercise Test, with measuring of the heart rate (beats per minute).

    12 weeks (baseline + every four weeks)

Secondary Outcomes (8)

  • Biochemical analysis - capillary blood

    12 weeks (2 times/week)

  • Biochemical analysis - venous blood

    12 weeks (2 times/week)

  • Biochemical analysis - venous blood

    12 weeks (2 times/week)

  • Anthropometrics - body height

    12 weeks (baseline + every four weeks)

  • Anthropometrics - body weight

    12 weeks (baseline + every four weeks)

  • +3 more secondary outcomes

Study Arms (4)

Ketogenic diet

EXPERIMENTAL

Ketogenic diet: * \< 50 g carbohydrates - CHO/d (based on the 1-week pre-intervention habitual diet monitoring) * protein restriction ≤ 1.5 g/kg free-fat mass (FFM)/day. * fat type intake recommendation: * natural fats * trans-FA reduction

Behavioral: Ketogenic diet

Exercise HIIT (High-Intensity Interval Training)

EXPERIMENTAL

Exercise intervention: \- HIIT: 5 min warm-up - slow walking, 3 min interval of high-intensity walking (above VT2), 3 min interval of low-intensity walking (40 % VO2peak); 5 min cool-down - slow walking: Cycle 1 * week 1-3 - 3 sessions/week, total time 31 min/session (4 intervals) * week 4 - regeneration: only 2 sessions with 2 intervals, keep total time 31 min/session, (+ GXT) Cycle 2 * week 5-7 - 3 sessions/week, total time 43 min/session (6 intervals) * week 8 - regeneration: only 2 sessions with 4 intervals, total time 31 min/session, (+ GXT) Cycle 3 * week 9-11 - 3 sessions/week, total time 55 min/session (8 intervals) * week 12 - regeneration: only 2 sessions with 6 intervals, total time 43min/session, (+GXT)

Behavioral: Exercise HIIT

Ketogenic diet + Exercise HIIT

EXPERIMENTAL

Ketogenic diet: * \< 50 g carbohydrates - CHO/d (based on the 1-week pre-intervention habitual diet monitoring) * protein restriction ≤ 1.5 g/kg free-fat mass (FFM)/day. * fat type intake recommendation: * natural fats * trans-FA reduction Exercise intervention: \- HIIT: 5 min warm-up - slow walking, 3 min interval of high-intensity walking (above VT2), 3 min interval of low-intensity walking (40 % VO2peak); 5 min cool-down - slow walking: Cycle 1 * week 1-3 - 3 sessions/week, total time 31 min/session (4 intervals) * week 4 - regeneration: only 2 sessions with 2 intervals, keep total time 31 min/session, (+ GXT) Cycle 2 * week 5-7 - 3 sessions/week, total time 43 min/session (6 intervals) * week 8 - regeneration: only 2 sessions with 4 intervals, total time 31 min/session, (+ GXT) Cycle 3 * week 9-11 - 3 sessions/week, total time 55 min/session (8 intervals) * week 12 - regeneration: only 2 sessions with 6 intervals, total time 43min/session, (+GXT)

Behavioral: Ketogenic dietBehavioral: Exercise HIIT

Control Group

NO INTERVENTION

The study subjects in this arm will undergo no dietary changes and no exercise intervention.

Interventions

Ketogenic dietBEHAVIORAL

The study subjects randomized for this intervention will observe the ketogenic diet, as prescribed by the protocol.

Ketogenic dietKetogenic diet + Exercise HIIT
Exercise HIITBEHAVIORAL

The study subjects randomized for this intervention will observe the HIIT exercise programme, as prescribed by the protocol.

Exercise HIIT (High-Intensity Interval Training)Ketogenic diet + Exercise HIIT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 25.00 - 40.00 kg/m2
  • non-smokers
  • non-excessive alcohol intake (self-reported, ≥ to 2 drinks/day for men or ≥1 drink/day for women)
  • willing to accept random assignment
  • low active individuals over the last 1 year, i.e. no specific sports training or regular exercise (up to once a week) and self-reported physical activity \< 150 min/week (IPAQ)
  • no evidence of liver, renal, metabolic, and cardiopulmonary disease and dis-eases contraindicating physical activity, no cancer, no psychiatric illness
  • Physical Activity Readiness Questionnaire (PAR-Q) pass
  • body weight stable for the last 2 months and not actively on a weight loss plan
  • prediabetes state allowed (impaired fasting glucose level, i.e. 5.6 - 6.9 mmol/l; HbA1c 5.7 - 6.4 %)

You may not qualify if:

  • pregnancy, lactation
  • any specific diet (e.g. vegetarian)
  • use of hypoglycemic, lipid-lowering, antihypertensive, psychiatric medications or medications known to affect body weight or energy expenditure; any medication not noted allowed if the individual had been stable while taking such medication for at least 3 months prior to baseline data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ostrava

Ostrava, Moravian-Silesian Region, 70103, Czechia

Location

Related Publications (4)

  • Cipryan L, Plews DJ, Ferretti A, Maffetone PB, Laursen PB. Effects of a 4-Week Very Low-Carbohydrate Diet on High-Intensity Interval Training Responses. J Sports Sci Med. 2018 May 14;17(2):259-268. eCollection 2018 Jun.

    PMID: 29769827RESULT

  • Cipryan L, Kosek V, Garcia CJ, Dostal T, Bechynska K, Hajslova J, Hofmann P. A lipidomic and metabolomic signature of a very low-carbohydrate high-fat diet and high-intensity interval training: an additional analysis of a randomized controlled clinical trial. Metabolomics. 2023 Dec 23;20(1):10. doi: 10.1007/s11306-023-02071-1.

    PMID: 38141101DERIVED

  • Cipryan L, Litschmannova M, Maffetone PB, Plews DJ, Dostal T, Hofmann P, Laursen PB. Very Low-Carbohydrate High-Fat Diet Improves Risk Markers for Cardiometabolic Health More Than Exercise in Men and Women With Overfat Constitution: Secondary Analysis of a Randomized Controlled Clinical Trial. Front Nutr. 2022 May 23;9:867690. doi: 10.3389/fnut.2022.867690. eCollection 2022.

    PMID: 35677551DERIVED

  • Cipryan L, Dostal T, Litschmannova M, Hofmann P, Maffetone PB, Laursen PB. Effects of a Very Low-Carbohydrate High-Fat Diet and High-Intensity Interval Training on Visceral Fat Deposition and Cardiorespiratory Fitness in Overfat Individuals: A Randomized Controlled Clinical Trial. Front Nutr. 2021 Dec 21;8:785694. doi: 10.3389/fnut.2021.785694. eCollection 2021.

    PMID: 34993222DERIVED

MeSH Terms

Conditions

ObesityChronic DiseaseMotor ActivityFatigue

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesBehavior

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Lukáš Cipryan, Ass.Prof.,PhDr.,PhD

    University of Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking will be used in this study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study subjects will be randomized into four study groups, one of which will be the control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2019

First Posted

May 1, 2019

Study Start

September 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

January 25, 2021

Record last verified: 2020-01

Locations

CZ(1)