Effects of Calorie Restriction and Whole-body Cooling Strategies on Psychoemotional State, Cognitive and Motor Functions

Sponsor
Lithuanian Sports University (Other)
Overall Status
Completed
CT.gov ID
NCT05545943
Collaborator
(none)
80
1
4
18.9
4.2

Study Details

Study Description

Brief Summary

Two protocols with calorie restriction (CR): 2 days CR+whole body cooling and 6 days CR. All procedures in both protocols were the same, except whole body cooling and duration of CR. 80 healthy 18-40 years participants were enrolled in the study and were randomly classified into 4 groups. In the experimental group (n = 20) participants received CR and whole body cooling, in two control groups (n=40) participants were asked not to change their living habits for 2-4 weeks. All participants had to proceed with familiarization with cognitive function, manual dexterity tests, and neuromuscular testing using isokinetic dynamometry before all measurements and evaluation. After baseline assessments, participants were randomized to the experimental and control groups.

Condition or Disease Intervention/Treatment Phase
  • Other: 48 hours calorie restriction and passive whole body cooling
  • Other: 6-day calorie restriction
N/A

Detailed Description

The study protocol began early in the morning after overnight fasting (10.7 ± 4.7 h). Firstly, participants were asked to weigh themselves and inserted the rectal thermometry to measure the core temperature. Skinfold thickness was measured using a skinfold caliper. After that participants were asked to lay in the supine position for 15 minutes in rest to measure resting heart rate (HR), heart rate variability (HRV), pulmonary gas exchange during the last 15 minutes, and blood pressure afterward. Subsequently, participants completed self-assessment questionnaires, and then saliva samples were collected for cortisol, women's sex hormones, and testosterone, also capillary and venous blood samples were taken for ketone, glucose, insulin, lipid profile, catecholamines, brain-derived neurotrophic factor, glucagon, and interleukin-10 concentrations measurements. The participant performed a manual dexterity test twice, continued to follow measurements of cognitive functions, neuromuscular and jumps tests were performed. At this point started the body cooling procedure with 2 days of CR+whole body cooling protocol. The experimental group subjects (n=40; 13 women) participated for 2-4 weeks. In the control group, participants (n=40; 12 women) were instructed not to engage in any CR and body cooling procedures. All tests and measurements were repeated after 2 days of CR in the same order as it was at the beginning of the study.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of 2-day and 6-day Calorie Restriction and Whole-body Cooling Strategies on Psychoemotional State, Cognitive and Motor Functions
Actual Study Start Date :
Feb 8, 2021
Actual Primary Completion Date :
Sep 5, 2022
Actual Study Completion Date :
Sep 5, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 2-day calorie restriction (CR) + whole body cooling (WBC)

20 healthy young subjects participated in a 2-day calorie restriction with short-term whole body cooling practice. Inclusion criteria were: body mass index (BMI) 18.5-34.9 kg/ m2, age 18-40 years, no excessive regular moderate or vigorous physical activity, i.e., ≥3 times per week; non-smokers, no medications that could affect the results of experiment, no history of any eating, oncological, metabolic, cardiovascular, skeletal, neuromuscular, pulmonary disorders or diseases, mental disabilities, no history of alcoholism or dependence on psychotropic drugs, women are not pregnant and not undergoing lactation. All participants were asked to not perform excessive sports activities while the research was ongoing, no involvement in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; no medications that could affect natural thermoregulation.

Other: 48 hours calorie restriction and passive whole body cooling
The 2-d (48 hours) calorie-restricted diet with two whole-body cooling in water on separate days. During intermittent cooling, every 20 min, the subject was asked to step out of the bath and rest for 10 min in the room environment, and then to return to the water bath for the next 20 min of immersion. Participants were immersed in a semirecumbent position up to the level of the manubrium in the 14 °C water bath.

Experimental: 6-day calorie restriction (CR)

20 healthy young subjects participated in 6-day calorie restriction practice. Inclusion criteria were: body mass index (BMI) 18.5-34.9 kg/ m2, age 18-40 years, no excessive regular moderate or vigorous physical activity, i.e., ≥3 times per week; non-smokers, no medications that could affect the results of the experiment, no history of any eating, oncological, metabolic, cardiovascular, skeletal, neuromuscular, pulmonary disorders or diseases, mental disabilities, no history of alcoholism or dependence on psychotropic drugs, women are not pregnant and not undergoing lactation. All participants were asked to not perform excessive sports activities while the research was ongoing, no involvement in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; no medications that could affect natural thermoregulation.

Other: 6-day calorie restriction
The 6-d (144 hours) calorie-restricted diet.

No Intervention: Control group for 2-day CR and WBC

In the control group, 20 subjects also had to meet the same criteria and not perform excessive sports activities, or any body cooling procedures, and have not CR in their daily living life.

No Intervention: Control group for 6-day CR

In the control group, 20 subjects also had to meet the same criteria and not perform excessive sports activities, and have no CR in their daily living life.

Outcome Measures

Primary Outcome Measures

  1. Heart Rate Variability [2-4 weeks]

    R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland) in laying position, in rest.

  2. Blood Pressure [2-4 weeks]

    Resting systolic and diastolic blood pressure was measured using a digital electronic blood pressure monitor (Microlife BP A100, Widnau, Switzerland)

  3. Self-Assessment Questionnaires - Brunel Mood Scale and Appetite sensations (hunger and fullness), perceived stress [2-4 weeks]

    This questionnaire contained 24 items (e.g., angry, uncertain, miserable, tired, nervous, and energetic) divided into six respective subscales: anger, confusion, depression, fatigue, tension, and vigor, and the items were answered on 5 points. The participant selected from a numerical rating scale of zero to four (0 = not at all, 1 = a bit, 2 = moderate, 3 = enough; 4 = extremely). Appetite sensations (hunger and fullness) and perceived stress were evaluated with visual analog scales (VAS) on a 100 mm (10cm) long horizontal line in which higher score indicates greater stress intensity: no stress (0-4 mm), mild stress (5-44 mm), moderate stress (45-74 mm), and the highest imaginable stress (75-100 mm).

  4. Manual Dexterity Test [2-4 weeks]

    The Grooved Pegboard were used to evaluate the ability to coordinate the fingers and manipulate objects promptly in time twice.

  5. Blood Analysis [2-4 weeks]

    The capillary blood samples were collected from finger to measure ketone level. Venous blood samples from the median antecubital vein were collected in 5 ml vacuum tubes with a gel separator and were separated by centrifugation (15 min at 1200g) to make blood serum. Samples were aliquoted and stored at -20°C until analysis. The serum concentrations of hormones: insulin, catecholamines, glucagon, sex hormones, interleukin-10, brain-derived neurotropic level were measured using an enzyme-linked immunoassay kits (R&D Systems, Minneapolis, USA; DIAsource ImmunoAssays S.A., Belgium). ELISA samples were tested in duplicates, then averaged the absorbance values for each set of standards and samples.

  6. Pulmonary Gas Exchange [2-4 weeks]

    Measurement of VO2 (oxygen consumption) and VCO2 (carbon dioxide output) every 5 s on a breath-by breath basis using an Oxycon Mobile spirometry system (Oxygen Mobile, Jaeger/ VIASYS Healthcare, Germany) at rest time.

  7. The Isokinetic Dynamometer Velocity [2-4 weeks]

    Muscle maximal voluntary force (MVJ) was induced by electrical stimulation involuntary force (NJ) moments and maximum voluntary force isometric load (MVJ) measured using an isokinetic dynamometer (Biodex, Medical System 3, New York, USA). The isokinetic dynamometer equipment allowed evaluation of strength, endurance, power and range of motion of calf muscle.

  8. Cognitive Function Performance Evaluation [2-4 weeks]

    The Automated Neuropsychological Assessment Metrics computer program was used to measure neurocognitive skills: motor reaction time, mental flexibility, mathematical processing, working memory, visual scanning, and associative learning skills. The following tests were used in the study: Simple reaction time, two choice reaction time, Memory search, Mathematical processing, Code substitution - learning, Code substitution - delayed, Go / No-Go, Matching grids.

  9. The Drop Jumps Measurements [2-4 weeks]

    Vertical jumps were used to measure height contact platform (60 x 60cm) and connected to it electronic jump and resistance duration meter. Jumps were performed while holding the hands of the subject on the hips were requested jump as high as possible. The height of the jump was measured by the length of time the subject stays jumped. In total, up to five tests will be performed, including 15 sec. intervals. The study will be conducted with a force mobile platform (AccuPower, AMTI, Watertown, MA, USA). The best three jumps were used for data analysis.

  10. Body mass index [2-4 weeks]

    The participant's weight (kg) and height (m) were combined to report BMI in kg/m^2.

  11. Skinfold Thickness [2-4 weeks]

    Skinfolds thickness was measured using a skinfold caliper (SH5020, Saehan, Masan, Korea) with Jackson-Pollock 7point skinfold formula at 7 sites: chest, midaxilla, triceps, subscapular, abdominal, suprailiac and thigh.

Secondary Outcome Measures

  1. Weight Measurement [2-4 weeks]

    Body weight was measured by Tanita Body Composition Analyzer TBF-300 (Japan).

  2. Height Measurement [2-4 weeks]

    The height was measured by a centimeter strip.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • body mass index (BMI) 18.5-34.9 kg/ m2,

  • age 18-40 years,

  • no excessive regular moderate or vigorous physical activity, i.e., ≥3 times per week;

  • non-smokers,

  • no medications that could affect the results of the experiment,

  • no history of any eating, oncological, metabolic, cardiovascular, skeletal, neuromuscular, pulmonary disorders or diseases, mental disabilities,

  • no history of alcoholism or dependence on psychotropic drugs,

  • women are not pregnant and not undergoing lactation.

Exclusion Criteria:
  • persons suffering from mental, oncological, cardiovascular, skeletal, muscular, respiratory disorders, or diseases after physical exhaustion will not be invited to the study;

  • after surgery; injuries (in last 3 years);

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lithuanian Sports University Kaunas Lithuania

Sponsors and Collaborators

  • Lithuanian Sports University

Investigators

  • Study Director: Rima Solianik, PhD, Lithuanian Sports University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lithuanian Sports University
ClinicalTrials.gov Identifier:
NCT05545943
Other Study ID Numbers:
  • LithuanianSportsU-10
First Posted:
Sep 19, 2022
Last Update Posted:
Sep 19, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 19, 2022