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

NCT ID: NCT05545943

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2022-10-05

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.

Conditions

Calorie Deficiency; Fasting; Cold Exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

2-days of calorie restriction with whole body cooling

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

6-days of calorie restriction

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.

Group Type: EXPERIMENTAL

6-days of calorie restriction

Intervention Type: OTHER

The 6-days (144 hours) of prescribed zero-calorie prescribed diet with water provided ad libitum.

2-days of the usual diet (control)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

6 days of the usual diet (control)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

2-days of calorie restriction without whole-body cooling

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

2 days (48 hours) of prescribed zero-calorie diet with water provided ad libitum .

2-days of usual diet with whole-body cooling

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

6-days of calorie restriction

The 6-days (144 hours) of prescribed zero-calorie prescribed diet with water provided ad libitum.

Intervention Type: 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 .

Intervention Type: 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.

Intervention Type: OTHER

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lithuanian Sports University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katerina Židonienė

Role: PRINCIPAL_INVESTIGATOR

Lithuanian Sports University

Locations

Lithuanian Sports University

Kaunas, , Lithuania

Countries

Lithuania

References

Solianik R, Zidoniene K, Baranauskiene N, Brazaitis M. Fasting for 48 h induced similar glucose intolerance in both sexes despite greater perceived stress and decreased estradiol levels in females. Eur J Appl Physiol. 2024 May;124(5):1449-1459. doi: 10.1007/s00421-023-05378-y. Epub 2023 Dec 18.

Reference Type: DERIVED

PMID: 38108909 (View on PubMed)

Other Identifiers

LithuanianSportsU-10

Identifier Type: -

Identifier Source: org_study_id