Clinical trial NCT05545943: Effects of Calorie Restriction and Cold Stimuli on Health-related Indicators, Cognitive and Motor Functions
Official title: Effects of 2-day and 6-day Calorie Restriction and Whole-body Cooling Strategies on Health-related Indicators, Cognitive and Motor Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calorie Deficiency
Fasting
Cold Exposure
Keywords: cognition
motor function
metabolism
young adults
fasting
starvation
men
women
calorie deprivation
stress
kynurines
catecholamines
glucose tolerance
energy expenditure
weight loss
Lead sponsor: Lithuanian Sports University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This project consisted of two parts. For the first part was used randomized parallel model, and we aimed to investigate fasting duration effect, whereas for the second part was used randomized crossover model and we aimed to investigate if cold exposure can modify fasting evoked effects on health-related indicators, cognition and motor function.
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial was to identify if duration of acute calorie restriction (CR)/fasting or combination CR with cold stimuli have any effects on mental and physical health-related markers, and to clarify if different fasting strategies have any effect on cognitive and motor functioning efficiency in different genders.

The main questions it aims to answer were:

* Does fasting duration have any effect on fasting evoked responses?
* Does cold interventions can modulate fasting evoked responses?
* Does sex have any effect on acute fasting evoked responses?

For the first part, participants were randomly classified into 4 groups: two experimental groups: 2-days of CR (0 kcal diet) and 6-days of CR (0 kcal diet), and two control groups: 2-days or 6-days usual diet. For the second part, participants were randomly assigned to undergo the following conditions: 2-days of CR with two 10-min whole-body cold-water immersions on separate days, 2-days of CR without cold-water immersion, 2-days without CR with two 10-min whole-body cold-water immersions on separate days, or 2-days of the usual diet without cold-water immersion in a randomized crossover fashion. Changes in anthropometric characteristics, perceived stress, metabolism, overall health (total blood count, sex hormones, etc.), psycho-emotional state, cognitive and motor functions were examined.

Detailed description: The goal of this clinical trial was to identify if duration of acute calorie restriction (CR)/fasting or combination CR with cold stimuli have any effects on mental and physical health-related markers, and to clarify if different fasting strategies have any effect on cognitive and motor functioning efficiency in different genders.

At first study part, participants were randomly classified into 4 groups: two experimental groups: 2-days of calorie restriction (CR) (0 kcal diet) and 6-days of CR (0 kcal diet), and two control groups: 2-days or 6-days usual diet. In the experimental groups, the participants were instructed to follow a prescribed zero-calorie diet with water provided ad libitum over a period of 2 or 6 days. In the control groups, the participants were instructed to maintain their previous eating habits for 2 or 6 days. Body weight and composition, heart rate variability, pulmonary gas exchange, blood pressure, and body temperature were assessed. Subsequently, participants completed self-assessment questionnaires, and then saliva samples were collected for further cortisol and sex hormones analysis, also capillary and venous blood samples were taken for ketone, glucose, insulin, lipid profile, catecholamines, brain-derived neurotrophic factor, total antioxidant capacity, malondialdehyde, glucagon, interleukin-10, metabolites of the kynurenines pathway and complete blood count concentrations evaluation. Then, the manual dexterity, and the cognitive and neuromuscular functions were assessed. The same measurements were repeated before each trial, after each trial and after 1 week.

At second part, participants were randomly assigned to undergo the following conditions: 2-days of CR with two 10-min whole-body cold-water immersions on separate days, 2-days of CR without cold-water immersion, 2-days without CR with two 10-min whole-body cold-water immersions on separate days, or 2-days of the usual diet without cold-water immersion in a randomized crossover fashion. The same measurements described in first part were repeated before each and after each condition.

Eligibility criteria: Inclusion criteria:

* body mass index 19.5-29.9 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 or conditions that could be worsened by exposure to acute cold (14°) water or fasting and affect experimental variables,
* no history of alcoholism or dependence on psychotropic drugs,
* no blood/needle phobia,
* no involvement in any temperature-manipulation program or extreme temperature exposure for ⩾3 months,

Exclusion criteria: smoking, were in a weight-reduction program, followed a low-carbohydrate diet.

Primary outcomes:
measure: Change in body mass and body composition (kg)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in body mass index (kg/m2)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in substrate oxidation
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in energy expenditure (kcal/day)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in body temperature (°C)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in heart rate variability (ms)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in heart rate variability (time domain) (ms)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in heart rate variability (time domain) (Ln)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in heart rate variability (frequency domain) (ms2)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in heart rate variability (frequency domain) (Ln)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in heart rate variability (frequency domain) (nu)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in heart rate (bpm)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in blood pressure (mmHg)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in perceived stress
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in appetite sensations
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in mood state
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in venous complete blood count (10^9/L)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in venous complete blood count (%)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in serum female sex hormones concentration (pg/mL)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in serum female sex hormones concentration (mIU/ml)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in serum brain-derived neurotrophic factor concentration (pg/ml)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in serum interleukin-10 concentration (pg/ml)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in serum insulin concentration (μIU/ml)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in serum glucagon concentration (pg/ml)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in plasma catecholamines concentration (ng/ml)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in plasma malondialdehyde concentration (nmol/ml)
timeFrame: Pre-condition, 48, 84 and 144 hours post-condition, and 1 week after recovery
measure: Change in plasma total antioxidant capacity (mmol/l)
timeFrame: Pre-condition, 48, 84 and 144 hours post-condition, and 1 week after recovery
measure: Change in venous glucose concentration (mmol/l)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in insulin sensitivity
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in plasma metabolites of the kynurenine pathway (μm)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in salivary cortisol concentration (µg/dl)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in salivary testosterone concentration (µg/dl)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in capillary lipid profile (mmol/l)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in manual dexterity performance (sec)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in information processing (μV)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in information processing (ms)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in brain neural network activity (µV2)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in cognitive performance (ms)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in cognitive performance (%)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in reflexes (mV)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in reflexes (ms)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in muscle activity (mV)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in muscle activity (Hz)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in voluntary torque (Nm)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in involuntary torque (Nm)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in muscle contraction and relaxation (ms)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in central activation ratio (%)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in reactive strength
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in jump performance (cm)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in jump performance (m/s)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
Secondary outcomes:
measure: Change in height (m)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in skinfold thickness (mm)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in body fatness (%)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in physical activity (Step count)
timeFrame: 3 days before condition, during 48 or 144 hours of interventions and during 1 week post-condition. (2 weeks)
measure: Change in sleep (h)
timeFrame: 3 days before condition, during 48 or 144 hours of interventions and during 1 week post-condition. (2 weeks)]
measure: Change in oxygen consumption and carbon dioxide output (ml/min)
timeFrame: Pre-condition, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in capillary blood ketone concentrations (mmol/l)
timeFrame: Pre-condition, 24, 48 or 144 hours post-condition, and 1 week after recovery
measure: Change in capillary blood glucose concentrations (mmol/L)
timeFrame: Pre-condition, 24, 48 or 144 hours post-condition, and 1 week after recovery
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian Sports University
Study officials:
affiliation: Lithuanian Sports University
name: Katerina Židonienė
role: PRINCIPAL_INVESTIGATOR
References: