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Completed

NCT Number: NCT03934476

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ostrava

Ostrava, Moravian-Silesian Region, 70103, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 %)

Exclusion criteria

  • 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

Treatment and study plan

Ketogenic diet

Behavioral

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

Exercise HIIT

Behavioral

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

Primary outcomes

  1. Change in the time to exhaustion

    Time frame: 12 weeks (baseline + every four weeks)

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

  2. Change in cardiorespiratory variables - oxygen consumption

    Time frame: 12 weeks (baseline + every four weeks)

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

  3. Change in cardiorespiratory variables - heart rate

    Time frame: 12 weeks (baseline + every four weeks)

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

Secondary outcomes

  1. Biochemical analysis - capillary blood

    Time frame: 12 weeks (2 times/week)

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

  2. Biochemical analysis - venous blood

    Time frame: 12 weeks (2 times/week)

    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.

  3. Biochemical analysis - venous blood

    Time frame: 12 weeks (2 times/week)

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

  4. Anthropometrics - body height

    Time frame: 12 weeks (baseline + every four weeks)

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

  5. Anthropometrics - body weight

    Time frame: 12 weeks (baseline + every four weeks)

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

  6. Anthropometrics - waist circumference

    Time frame: 12 weeks (baseline + every four weeks)

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

  7. Anthropometrics - DXA

    Time frame: 12 weeks (baseline + outcome)

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

  8. InBody (bioimpedance)

    Time frame: 12 weeks (baseline + every four weeks)

    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.

Sponsors and collaborators

Lead sponsor

University of Ostrava

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 1, 2019
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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