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ObesityNCT03934476

The Effects of Lowering Dietary Carbohydrates on Health, Exercise Performance and Wellbeing-related Outcomes

A study testing Ketogenic diet and Exercise HIIT in people with Obesity and Diet Modification, run by University of Ostrava at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity, Diet Modification
What is being tested?
Ketogenic diet and Exercise HIIT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCzechia
Study dates
1 Sep 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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 %)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • University of Ostrava

    Ostrava, Moravian-Silesian Region, 70103

Other trials in Czechia

About this study

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.

Read the detailed description

Intentional nutritional ketosis induced by the low carbohydrate diet is an intensively discussed topic of many scientific as well as non-scientific discussions throughout the areas of healthy living, the sports sciences and often used now for the prevention and treatment of chronic diseases. It has been demonstrated that long-term low-carbohydrate diet is more effective for weight loss and cardiovascular and metabolic risk factor reduction than a low-fat diet. In light of conflicting theories of best practice surrounding a polarized topic that impacts human health and daily work performance, the primary aim of this research project is to examine how low-carbohydrate ketogenic diets affect health markers, exercise performance and wellbeing outcomes in sedentary overweight individuals. Each study subject will be randomized into one of the four arms of the study and will undergo a 12-week intervention, with the exception of the study subjects in the control group, who will undergo no intervention for the period of 12 weeks.

The project outcomes are of immense importance for the investigator's global human health, focus on a unique holistic perspective and have the potential to contribute towards much-needed adjustments in public health recommendations.

Being tested
Ketogenic diet, Exercise HIIT
Keywords
ketogenic diet, carbohydrates, chronic diseases, physical activity, fatigue, mood, wellbeing
Medical subject headings
Obesity, Chronic Disease, Motor Activity, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketogenic dietBehavioural

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

  • Exercise HIITBehavioural

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

Study groups in NCT03934476
Study groupRoleWhat they receive
Ketogenic dietExperimentalKetogenic 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
Receives: Behavioral: Ketogenic diet
Exercise HIIT (High-Intensity Interval Training)ExperimentalExercise 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)
Receives: Behavioral: Exercise HIIT
Ketogenic diet + Exercise HIITExperimentalKetogenic 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)
Receives: Behavioral: Ketogenic diet; Behavioral: Exercise HIIT
Control GroupNo interventionThe study subjects in this arm will undergo no dietary changes and no exercise intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the time to exhaustion

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

    Measured: 12 weeks (baseline + every four weeks)

  2. Change in cardiorespiratory variables - oxygen consumption

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

    Measured: 12 weeks (baseline + every four weeks)

  3. Change in cardiorespiratory variables - heart rate

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

    Measured: 12 weeks (baseline + every four weeks)

Secondary outcomes (8)

  1. Biochemical analysis - capillary blood

    All study subjects will undergo biochemical analysis of capillary blood - βHB and fasting glukose in mmol/L.

    Measured: 12 weeks (2 times/week)

  2. Biochemical analysis - venous blood

    All study subjects will undergo biochemical analysis of venous blood - oxidative stress, inflammation, total CHO, HDL, LDL, TG, FFA, GL, homocysteine, measured in mmol/L.

    Measured: 12 weeks (2 times/week)

  3. Biochemical analysis - venous blood

    All study subjects will undergo biochemical analysis of venous blood - HBA1c in mmol/mol.

    Measured: 12 weeks (2 times/week)

  4. Anthropometrics - body height

    All study subjects will undergo anthropometric assessment of the body height, measured in cm.

    Measured: 12 weeks (baseline + every four weeks)

  5. Anthropometrics - body weight

    All study subjects will undergo anthropometric assessment of the body weight, measured in kg.

    Measured: 12 weeks (baseline + every four weeks)

  6. Anthropometrics - waist circumference

    All study subjects will undergo anthropometric assessment of the waist circumference, measured in cm.

    Measured: 12 weeks (baseline + every four weeks)

  7. Anthropometrics - DXA

    All study subjects will undergo anthropometric assessment of DXA - total abdominal fat, measured in kg.

    Measured: 12 weeks (baseline + outcome)

  8. InBody (bioimpedance)

    All study subjects will undergo antrhropometric assessment of bioimpedance using the InBody device showing the percentage of water and fat in the organism, measured in % of total body weight.

    Measured: 12 weeks (baseline + every four weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2019
  2. Study start1 Sep 2018
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study subjects will be randomized into four study groups, one of which will be the control group.
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03934476
Sponsor's protocol ID
OU-PdF-GACR-LCHF diet
Other IDs
18-08358S
Status last verified
Jan 2020
First submitted
15 Feb 2019
Last updated
25 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The investigators have not decided to share the individual participant data with other researchers.

Publications

  • 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.

    PubMed 29769827

  • 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.

    PubMed 38141101

  • 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.

    PubMed 35677551

  • 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.

    PubMed 34993222

Questions about this trial

What is this clinical trial studying?

A study testing Ketogenic diet and Exercise HIIT in people with Obesity and Diet Modification, run by University of Ostrava at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the time to exhaustion (time frame: 12 weeks (baseline + every four weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03934476, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.

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