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

NCT05545943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-07-15

No results posted yet for this study

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.

Conditions

  • Calorie Deficiency
  • Fasting
  • Cold Exposure

Interventions

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.

Sponsors & Collaborators

  • Lithuanian Sports University

    lead OTHER

Principal Investigators

  • Katerina Židonienė · Lithuanian Sports University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2022-09-05
Completion
2022-10-05

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05545943 on ClinicalTrials.gov