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NCT04016909
The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women
NA trial testing aerobic exercise plus calorie restriction in Obesity in 26 participants. Completed in 31 July 2019.
15 June 2019
Quick facts
| Lead sponsor | Lithuanian Sports University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 1 October 2018 |
| Primary completion | 15 June 2019 |
| Estimated completion | 31 July 2019 |
| Sites | 1 location across Lithuania |
Drugs / interventions tested
- aerobic exercise plus calorie restriction
Conditions studied
- Obesity — all drugs for Obesity →
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
Sponsor
Lithuanian Sports University
Who can join
Adults 35 to 55, female only, with Obesity or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04016909
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04016909 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lithuanian Sports University
- Last refreshed: 10 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04016909.
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