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Completed

NCT Number: NCT04016909

The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women

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.

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Key information

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laura Zlibinaite

Kaunas, 44221, Lithuania

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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).

Exclusion criteria

  • undergoing lactation;
  • pregnant or postmenopausal;
  • type 2 diabetes;
  • cardiovascular disease.

Treatment and study plan

aerobic exercise plus calorie restriction

Procedure

both a 6-month aerobic exercise program (moderate intensity) and caloric restriction (12.5% energy deficit)

Primary outcomes

  1. 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.

  2. 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."

  3. 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).

  4. Height

    Time frame: baseline

    Body height was measured in meters with an accuracy of 5 mm

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Changes in body weight

    Time frame: 6 months

    weight (TBF-300 body composition scale; Tanita, UK Ltd., UK) was measured while the participants wore only underwear and were barefoot.

  2. Changes in mood state

    Time frame: 6 months

    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."

  3. changes in blood brain-derived neurotrophic factor (BDNF)

    Time frame: 6 months

    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).

  4. Improvement of cognitive functions

    Time frame: 6 months

    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.

  5. Changes in prefrontal cortex activity

    Time frame: 6 months

    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.

  6. Improvement of psychomotor function

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Lithuanian Sports University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2019
Registry last updated
Dec 10, 2019

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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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