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

Lithuanian Sports University

Status: Completed

Conditions: Cold Exposure; Fasting; Calorie Deficiency

Treatments: Other: 2-days of usual diet with whole-body cold-water immersion; Other: 2-days of zero calorie restriction without whole-body cold-water immersion; Other: 2-days of zero calorie restriction and whole-body cold-water immersion; Other: 6-days of calorie restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT05545943

LithuanianSportsU-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 6 patient groups

2-days of calorie restriction with whole body cooling

Experimental group

Description:

Healthy young subjects participated in a 2-day CR (0 kcal with water provided ad libitum ) with two 10-min whole body cooling practices on separate days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; do not use any medications that could affect experimental data.

Treatment:

Other: 2-days of zero calorie restriction and whole-body cold-water immersion

6-days of calorie restriction

Experimental group

Description:

Healthy young subjects participated in 6-day CR (0 kcal with water provided ad libitum). All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; do not use any medications that could affect experimental data.

Treatment:

Other: 6-days of calorie restriction

2-days of the usual diet (control)

No Intervention group

Description:

During the control trial, the healthy young subjects were instructed to maintain their previous eating habits for 2 days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months, CR programmes; do not use any medications that could affect experimental data.

6 days of the usual diet (control)

No Intervention group

Description:

During the control trial, the healthy young subjects were instructed to maintain their previous eating habits for 6 days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months, CR programmes; do not use any medications that could affect experimental data.

2-days of calorie restriction without whole-body cooling

Experimental group

Description:

Healthy young subjects participated in a 2-day CR (0 kcal with water provided ad libitum ) without whole body cooling. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months; do not use any medications that could affect experimental data.

Treatment:

Other: 2-days of zero calorie restriction without whole-body cold-water immersion

2-days of usual diet with whole-body cooling

Active Comparator group

Description:

Healthy young subjects participated two 10-min whole body cooling practices on separate days and were instructed to maintain their previous eating habits for 6 days. All participants were asked to not perform excessive sports activities while the research was ongoing, not to be involved in any temperature-manipulation program or extreme temperature exposure for ⩾3 months, CR programmes; do not use any medications that could affect experimental data.

Treatment:

Other: 2-days of usual diet with whole-body cold-water immersion