ObesityNCT04016909
The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women
A study testing aerobic exercise plus calorie restriction in people with Obesity and Metabolic Syndrome, run by Lithuanian Sports University at 1 site in Lithuania.
Trial summary
The benefits of weight-loss programs on mood state and cognitive and motor behavior remain unclear and are largely limited to those of calorie restriction (CR) or physical exercise alone. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- aerobic exercise plus calorie restriction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Oct 2018to 31 Jul 2019
- 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 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- gender: female;
- body mass index (BMI) greater than 25 kg/m2;
- exhibiting weight stability (body weight change <2 kg) for at least 2 months prior to enrollment;
- sedentary lifestyle (regular exercise 1 h/week).
Who cannot join
- undergoing lactation;
- pregnant or postmenopausal;
- type 2 diabetes;
- cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
The benefits of weight-loss programs on mood state and cognitive and motor behavior remain unclear and are largely limited to those of calorie restriction (CR) or physical exercise alone. Our aim was to investigate the effect of a combined CR and aerobic exercise program on mood state, cognition-related brain activity, and cognitive and motor behavior in overweight and obese women. Twenty-six overweight or obese women were randomized to either a control group (no intervention) or an experimental group (aerobic exercise + 12.5% energy-intake reduction). Brain-derived neurotrophic factor (BDNF) levels, mood, prefrontal cortex activity, cognitive performance, and learning of a speed-accuracy task were evaluated before and 6 months after the beginning of the program. Confusion and depression increased in the control group (P < 0.05), whereas tension decreased in the experimental group (P < 0.05). BDNF level and learning of a speed-accuracy task remained unchanged. Although PFC activity and executive functions were not affected, the reaction time of visual scanning and associative learning were improved in the experimental group (P < 0.05). An improvement in reaction time during the speed-accuracy task was observed (P < 0.05). In conclusion, a 6-month combined CR and aerobic exercise intervention improved the psychosocial mental state of overweight and obese women. Although it improved motor planning during the speed-accuracy task, it had little impact on cognition and no effect on brain activity and learning of the speed-accuracy task.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- aerobic exercise plus calorie restriction
- Keywords
- brain activity, cognitive function, diet, exercise, motor behavior, psychosocial state
- Medical subject headings
- Obesity, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise plus calorie restrictionProcedure or surgery
both a 6-month aerobic exercise program (moderate intensity) and caloric restriction (12.5% energy deficit)
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise plus calorie restriction | Experimental | The experimental intervention: both exercise and calorie restriction, as described below:
Exercise intervention. 6 months, 72 supervised aerobic exercise training sessions on cycle ergometers, including 3 sessions of training per week. A warm-up procedure consisting of 5 min of low-intensity stretching was completed by all women before the aerobic training. Subsequently, a 50 min aerobic training at an intensity between 60% and 70% of the maximum heart rate (HR) was performed. Thereafter, a cool-down consisting of 5 min of low-intensity stretching and breathing exercises was completed. HR was recorded continuously throughout the training sessions using an HR monitor (S625X, Polar Electro, Kempele, Finland).
Calorie restriction intervention. The CR intervention was designed to create a 12.5% energy deficit, with the goal of reducing body weight by 5%-10% over 6 months. Receives: Procedure: aerobic exercise plus calorie restriction |
| Control | No intervention | No intervention and participants were instructed to maintain their regular physical activity and diet regime for 6 months; they were also prohibited from participating in any weight-loss or exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.
Measured: baseline
mood state
Mood was assessed using the 24-item Brunel Mood Scale, which estimates anger, confusion, depression, fatigue, tension, and vigor. Items are rated on a 5-point Likert scale anchored by 0 (not at all) and 4 (extremely), according to how participants feel "right now."
Measured: baseline
Blood brain-derived neurotrophic factor (BDNF)
Venous blood samples (5 mL) were collected and allowed to clot at room temperature. Serum was then separated by centrifugation for 15 min at 1,200 g (room temperature) and stored at -80°C until analysis. BDNF were measured using an enzyme-linked immunoassay system (Gemini; Stratec Biomedical, Birkenfeld, Germany).
Measured: baseline
Height
Body height was measured in meters with an accuracy of 5 mm
Measured: baseline
Cognitive functions
Automated Neuropsychological Assessment Metrics Version 4 (ANAM-4; Vista Life, USA) was used to measure neurocognitive skills: motor reaction time, mental flexibility, mathematical processing, working memory, visual scanning and associative learning skills. Participants were familiarized with the test battery twice before the experiments.
Measured: baseline
prefrontal cortex activity
Assessment of brain activity was performed on a continuous wave system (fNIR Imager 1100, fNIR Devices LLC, Potomac, MA, United States) using a flexible 16 optode probe set. The sensor has a temporal resolution of 500 ms per scan with a 2.5 cm source-detector separation allowing for approximately 1.25 cm penetration depth and 16 measurement locations on a rectangular grid covering the forehead region, designed to observe dorsal and inferior frontal cortical areas.
Measured: baseline
psychomotor function
During the speed-accuracy task, the participant was required to position the handle symbol (0.0035 m in diameter) in the start zone on the computer screen. The participant then had to react to the target (a green circle, 0.007 m in diameter) on the computer screen as fast as possible and to push the handle of the device so that the circle of the handle symbol reached the target as quickly and accurately as possible. The distance from the start zone to the target was 0.17 m. The endpoint of the movement was reached when the center of the handle symbol stopped in the circle and stayed there for at least 0.02 s.
Measured: baseline
Secondary outcomes (6)
Changes in body weight
weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.
Measured: 6 months
Changes in mood state
Mood was assessed using the 24-item Brunel Mood Scale, which estimates anger, confusion, depression, fatigue, tension, and vigor. Items are rated on a 5-point Likert scale anchored by 0 (not at all) and 4 (extremely), according to how participants feel "right now."
Measured: 6 months
changes in blood brain-derived neurotrophic factor (BDNF)
Venous blood samples (5 mL) were collected and allowed to clot at room temperature. Serum was then separated by centrifugation for 15 min at 1,200 g (room temperature) and stored at -80°C until analysis. BDNF were measured using an enzyme-linked immunoassay system (Gemini; Stratec Biomedical, Birkenfeld, Germany).
Measured: 6 months
Improvement of cognitive functions
Automated Neuropsychological Assessment Metrics Version 4 (ANAM-4; Vista Life, USA) was used to measure neurocognitive skills: motor reaction time, mental flexibility, mathematical processing, working memory, visual scanning and associative learning skills. Participants were familiarized with the test battery twice before the experiments.
Measured: 6 months
Changes in prefrontal cortex activity
Assessment of brain activity was performed on a continuous wave system (fNIR Imager 1100, fNIR Devices LLC, Potomac, MA, United States) using a flexible 16 optode probe set. The sensor has a temporal resolution of 500 ms per scan with a 2.5 cm source-detector separation allowing for approximately 1.25 cm penetration depth and 16 measurement locations on a rectangular grid covering the forehead region, designed to observe dorsal and inferior frontal cortical areas.
Measured: 6 months
Improvement of psychomotor function
During the speed-accuracy task, the participant was required to position the handle symbol (0.0035 m in diameter) in the start zone on the computer screen. The participant then had to react to the target (a green circle, 0.007 m in diameter) on the computer screen as fast as possible and to push the handle of the device so that the circle of the handle symbol reached the target as quickly and accurately as possible. The distance from the start zone to the target was 0.17 m. The endpoint of the movement was reached when the center of the handle symbol stopped in the circle and stayed there for at least 0.02 s.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Oct 2018
- Primary completion15 Jun 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016909
- Sponsor's protocol ID
- LithuanianSportsU-1
- Status last verified
- Dec 2019
- First submitted
- 9 Jul 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT04016909
- Acronym / sponsor ID
- LithuanianSportsU-1
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- brain activity, cognitive function, diet, exercise, motor behavior, psychosocial state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The benefits of weight-loss programs on mood state and cognitive and motor behavior remain unclear and are largely limited to those of calorie restriction (CR) or physical exercise alone. Our aim was to investigate the effect of a combined CR and aerobic exercise program on mood state, cognition-related brain activity, and cognitive and motor behavior in overweight and obese women. Twenty-six overweight or obese women were randomized to either a control group (no intervention) or an experimental group (aerobic exercise + 12.5% energy-intake reduction). Brain-derived neurotrophic factor (BDNF) levels, mood, prefrontal cortex activity, cognitive performance, and learning of a speed-accuracy task were evaluated before and 6 months after the beginning of the program. Confusion and depression increased in the control group (P < 0.05), whereas tension decreased in the experimental group (P < 0.05). BDNF level and learning of a speed-accuracy task remained unchanged. Although PFC activity and executive functions were not affected, the reaction time of visual scanning and associative learning were improved in the experimental group (P < 0.05). An improvement in reaction time during the speed-accuracy task was observed (P < 0.05). In conclusion, a 6-month combined CR and aerobic exercise intervention improved the psychosocial mental state of overweight and obese women. Although it improved motor planning during the speed-accuracy task, it had little impact on cognition and no effect on brain activity and learning of the speed-accuracy task.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise plus calorie restriction | Experimental | Procedure: aerobic exercise plus calorie restrictionThe experimental intervention: both exercise and calorie restriction, as described below: Exercise intervention. 6 months, 72 supervised aerobic exercise training sessions on cycle ergometers, including 3 sessions of training per week. A warm-up procedure consisting of 5 min of low-intensity stretching was completed by all women before the aerobic training. Subsequently, a 50 min aerobic training at an intensity between 60% and 70% of the maximum heart rate (HR) was performed. Thereafter, a cool-down consisting of 5 min of low-intensity stretching and breathing exercises was completed. HR was recorded continuously throughout the training sessions using an HR monitor (S625X, Polar Electro, Kempele, Finland). Calorie restriction intervention. The CR intervention was designed to create a 12.5% energy deficit, with the goal of reducing body weight by 5%-10% over 6 months. |
| Control | No intervention | –No intervention and participants were instructed to maintain their regular physical activity and diet regime for 6 months; they were also prohibited from participating in any weight-loss or exercise program. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- gender: female;
- body mass index (BMI) greater than 25 kg/m2;
- exhibiting weight stability (body weight change <2 kg) for at least 2 months prior to enrollment;
- sedentary lifestyle (regular exercise 1 h/week).
Key exclusion criteria (4 listed)
- undergoing lactation;
- pregnant or postmenopausal;
- type 2 diabetes;
- cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise plus calorie restrictionboth a 6-month aerobic exercise program (moderate intensity) and caloric restriction (12.5% energy deficit) | Procedure or surgery | aerobic exercise plus calorie restriction |
Primary outcome
Weight
Time frame: baseline
weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.
mood state
Time frame: baseline
Mood was assessed using the 24-item Brunel Mood Scale, which estimates anger, confusion, depression, fatigue, tension, and vigor. Items are rated on a 5-point Likert scale anchored by 0 (not at all) and 4 (extremely), according to how participants feel "right now."
Blood brain-derived neurotrophic factor (BDNF)
Time frame: baseline
Venous blood samples (5 mL) were collected and allowed to clot at room temperature. Serum was then separated by centrifugation for 15 min at 1,200 g (room temperature) and stored at -80°C until analysis. BDNF were measured using an enzyme-linked immunoassay system (Gemini; Stratec Biomedical, Birkenfeld, Germany).
Height
Time frame: baseline
Body height was measured in meters with an accuracy of 5 mm
Cognitive functions
Time frame: baseline
Automated Neuropsychological Assessment Metrics Version 4 (ANAM-4; Vista Life, USA) was used to measure neurocognitive skills: motor reaction time, mental flexibility, mathematical processing, working memory, visual scanning and associative learning skills. Participants were familiarized with the test battery twice before the experiments.
prefrontal cortex activity
Time frame: baseline
Assessment of brain activity was performed on a continuous wave system (fNIR Imager 1100, fNIR Devices LLC, Potomac, MA, United States) using a flexible 16 optode probe set. The sensor has a temporal resolution of 500 ms per scan with a 2.5 cm source-detector separation allowing for approximately 1.25 cm penetration depth and 16 measurement locations on a rectangular grid covering the forehead region, designed to observe dorsal and inferior frontal cortical areas.
psychomotor function
Time frame: baseline
During the speed-accuracy task, the participant was required to position the handle symbol (0.0035 m in diameter) in the start zone on the computer screen. The participant then had to react to the target (a green circle, 0.007 m in diameter) on the computer screen as fast as possible and to push the handle of the device so that the circle of the handle symbol reached the target as quickly and accurately as possible. The distance from the start zone to the target was 0.17 m. The endpoint of the movement was reached when the center of the handle symbol stopped in the circle and stayed there for at least 0.02 s.
6 secondary outcomes
Changes in body weight
Time frame: 6 months
Changes in mood state
Time frame: 6 months
changes in blood brain-derived neurotrophic factor (BDNF)
Time frame: 6 months
Improvement of cognitive functions
Time frame: 6 months
Changes in prefrontal cortex activity
Time frame: 6 months
Improvement of psychomotor function
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise plus calorie restriction in people with Obesity and Metabolic Syndrome, run by Lithuanian Sports University at 1 site in Lithuania.
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 4 inclusion and 4 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 10 Dec 2019. 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 Lithuania. 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?
Weight (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2019.