NCT05545943

Effects of Calorie Restriction and Cold Stimuli on Health-related Indicators, Cognitive and Motor Functions

Effects of 2-day and 6-day Calorie Restriction and Whole-body Cooling Strategies on Health-related Indicators, Cognitive and Motor Functions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Lithuanian Sports University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Calorie Deficiency
• Fasting
• Cold Exposure

Interventions

Type	Name	Description
OTHER	2-days of zero calorie restriction and whole-body cold-water immersion	The 2-days (48 hours) of zero-calorie restricted diet (with water provided ad libitum) with two whole-body cold-water immersion sessions on separate days. During cooling procedures, the participant was immersed in 14° water bath in semi recumbent position up to the level of the manubrium for 10 min.
OTHER	6-days of calorie restriction	The 6-days (144 hours) of prescribed zero-calorie prescribed diet with water provided ad libitum.
OTHER	2-days of zero calorie restriction without whole-body cold-water immersion	2 days (48 hours) of prescribed zero-calorie diet with water provided ad libitum .
OTHER	2-days of usual diet with whole-body cold-water immersion	Two whole-body cold-water immersion sessions on separate days. During cooling procedures, the participant was immersed in 14° water bath in semi recumbent position up to the level of the manubrium for 10 min. During intervention, participants were instructed to maintain their previous eating habits.

Timeline

• Start date: 2021-02-08
• Primary completion: 2022-09-05
• Completion: 2022-10-05
• First posted: 2022-09-19
• Last updated: 2024-07-15

Locations

1 site across 1 country: Lithuania