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| ID | Type | Description | Link |
|---|---|---|---|
| 18-08358S | Other Grant/Funding Number | GACR |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic diet | Experimental | 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
Cycle 2
Cycle 3
|
|
| Ketogenic diet + Exercise HIIT | Experimental | Ketogenic diet:
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
Cycle 2
Cycle 3
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic diet | Behavioral | The study subjects randomized for this intervention will observe the ketogenic diet, as prescribed by the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical analysis - capillary blood | All study subjects will undergo biochemical analysis of capillary blood - βHB and fasting glukose in mmol/L. | 12 weeks (2 times/week) |
| Biochemical analysis - venous blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lukáš Cipryan, Ass.Prof.,PhDr.,PhD | University of Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ostrava | Ostrava | Moravian-Silesian Region | 70103 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29769827 | Result | 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. | |
| 38141101 | Derived | 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. |
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The investigators have not decided to share the individual participant data with other researchers.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D002908 | Chronic Disease |
| D009043 | Motor Activity |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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The study subjects will be randomized into four study groups, one of which will be the control group.
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No masking will be used in this study.
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|
| Control Group | No Intervention | The study subjects in this arm will undergo no dietary changes and no exercise intervention. |
| Exercise HIIT | Behavioral | The study subjects randomized for this intervention will observe the HIIT exercise programme, as prescribed by the protocol. |
|
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.
| 12 weeks (2 times/week) |
| Biochemical analysis - venous blood | All study subjects will undergo biochemical analysis of venous blood - HBA1c in mmol/mol. | 12 weeks (2 times/week) |
| Anthropometrics - body height | All study subjects will undergo anthropometric assessment of the body height, measured in cm. | 12 weeks (baseline + every four weeks) |
| Anthropometrics - body weight | All study subjects will undergo anthropometric assessment of the body weight, measured in kg. | 12 weeks (baseline + every four weeks) |
| Anthropometrics - waist circumference | All study subjects will undergo anthropometric assessment of the waist circumference, measured in cm. | 12 weeks (baseline + every four weeks) |
| Anthropometrics - DXA | All study subjects will undergo anthropometric assessment of DXA - total abdominal fat, measured in kg. | 12 weeks (baseline + outcome) |
| 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. | 12 weeks (baseline + every four weeks) |
| 35677551 | Derived | 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. |
| 34993222 | Derived | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D001519 | Behavior |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |