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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03934476

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted May 1, 2019

Study Description

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.

  • Condition or Disease:Obesity
    Diet Modification
  • Intervention/Treatment: Behavioral: Ketogenic diet
    Behavioral: Exercise HIIT
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: The study subjects will be randomized into four study groups, one of which will be the control group.
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: The Effects of Lowering Dietary Carbohydrates on Health, Exercise Performance and Wellbeing-related Outcomes
  • Actual Study Start Date: September 2018
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: December 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Ketogenic diet
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
The study subjects randomized for this intervention will observe the ketogenic diet, as prescribed by the protocol.
Experimental: Ketogenic diet + Exercise HIIT
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 diet
The study subjects randomized for this intervention will observe the ketogenic diet, as prescribed by the protocol.

Behavioral: Exercise HIIT
The study subjects randomized for this intervention will observe the HIIT exercise programme, as prescribed by the protocol.
Experimental: Exercise HIIT (High-Intensity Interval Training)
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
The study subjects randomized for this intervention will observe the HIIT exercise programme, as prescribed by the protocol.
Outcome Measures
  • Primary Outcome Measures: 1. 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).
  • 2. 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).
  • 3. 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.
  • Secondary Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: Václav Procházka, MD,PhD,MSc,MBA 0042059737 ext 2171 vaclav.prochazka@fno.cz

Contact: Pavla Dřízgová, Bc. 0042059709 ext 1717 pavla.drizgova@osu.cz

Locations

Czechia, Moravian-Silesian Region
University of Ostrava
Ostrava

Sponsors and Collaborators

University of Ostrava

Investigators

Principal Investigator: Lukáš Cipryan, Ass.Prof.,PhDr.,PhD University of Ostrava

More Information