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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934476
• Other study ID #: OU-PdF-GACR-LCHF diet
• Secondary ID: 18-08358S
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2020
• Source: University of Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification
• Obesity

Intervention

Behavioral:
• Ketogenic diet
The study subjects randomized for this intervention will observe the ketogenic diet, as prescribed by the protocol.
• Exercise HIIT
The study subjects randomized for this intervention will observe the HIIT exercise programme, as prescribed by the protocol.

Locations

Country	Name	City	State
Czechia	University of Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University of Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Biochemical analysis - capillary blood	All study subjects will undergo biochemical analysis of capillary blood - ßHB and fasting glukose in mmol/L.	12 weeks (2 times/week)
Secondary	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.	12 weeks (2 times/week)
Secondary	Biochemical analysis - venous blood	All study subjects will undergo biochemical analysis of venous blood - HBA1c in mmol/mol.	12 weeks (2 times/week)
Secondary	Anthropometrics - body height	All study subjects will undergo anthropometric assessment of the body height, measured in cm.	12 weeks (baseline + every four weeks)
Secondary	Anthropometrics - body weight	All study subjects will undergo anthropometric assessment of the body weight, measured in kg.	12 weeks (baseline + every four weeks)
Secondary	Anthropometrics - waist circumference	All study subjects will undergo anthropometric assessment of the waist circumference, measured in cm.	12 weeks (baseline + every four weeks)
Secondary	Anthropometrics - DXA	All study subjects will undergo anthropometric assessment of DXA - total abdominal fat, measured in kg.	12 weeks (baseline + outcome)
Secondary	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)