cardiovascular diseases cardiovascular diseases
Conditions
Interventions
Cold exposure using either a cooling vest or cold showers 
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Part 1 - Pilot study For the pilot study, a subject must meet the following criteria: - Males or females with Europid ethnicity OR with South Asian ethnicity (South Asian ethnicity is defined as having 4 grandparents that originally descended from either Bangladesh, India, Nepal, Pakistan, Afghanistan, Bhudan or Sri Lanka or are from Hindu-Surinamese descent) - Age between 20 and 50 years - Living with overweight or obesity (Europids: BMI 25 - 35 kg/m2; South Asians: BMI 23 - 35 kg/m2, since a BMI of 23 is already regarded as *overweight* in South Asians; or a BMI < 35 kg/m² and a waist circumference of >=80 cm for females; or a BMI < 35 kg/m² and a waist circumference of >=94 cm for male Europids; or a BMI < 35 kg/m² and a waist circumference of >=90 cm for male South Asians) (BMI 25 - 35 kg/m2) - Capable of giving written informed consent Part 2 - Cooling vest study In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Males or females with Europid ethnicity OR with South Asian ethnicity (South Asian ethnicity is defined as having 4 grandparents that originally descended from either Bangladesh, India, Nepal, Pakistan, Afghanistan, Bhudan or Sri Lanka or are from Hindu-Surinamese descent) - Age between 20 and 50 years (South Asians: 20 to 55 years) - Living with overweight or obesity (Europids: BMI 25 - 35 kg/m2; South Asians: BMI 23 - 35 kg/m2, since a BMI of 23 is already regarded as *overweight* in South Asians; or a BMI < 35 kg/m² and a waist circumference of >=80 cm for females; or a BMI < 35 kg/m² and a waist circumference of >=94 cm for male Europids; or a BMI < 35 kg/m² and a waist circumference of >=90 cm for male South Asians) - Capable of giving written informed consent - Able to comply with the requirements and restrictions listed in the informed consent form Part 3 - Cold shower study Inclusion criteria are largely similar compared with part 2, but here only females with Europid ethnicity will be included.Part 4 - Implementation studyInclusion criteria are largely similar compared with part 2, but here only females with Europid ethnicity will be included.
Exclusion criteria
Exclusion criteria: Part 1 - Pilot study A potential subject who meets any of the following criteria will be excluded from participation in the pilot study: - Any cardiovascular disease (i.e. ischemic heart disease, arrythmias, severe heart failure, untreated hypertension) - A first-degree family member with sudden cardiac death - Abuse of alcohol (regularly more than 2 glasses per day) or use of any drugs of abuse - Smoking - Pregnancy - Active cold water swimmers (at least once weekly during winter) - Taking cold showers (in the past 6 weeks at least once weekly) In case potential participants are active cold water swimmers or take cold showers, after a wash-out period of at least 6 weeks, they can participate in Part 1. Part 2 - Cooling vest study A potential subject who meets any of the following criteria will be excluded from participation in this study: - Diabetes mellitus (determined on basis of fasting glucose levels defined by ADA criteria) - Any other active endocrine disease (thyroid disease, any signs of Cushing*s syndrome, adrenal disease and lipid-associated disorders such as familial hypercholesterolemia) - Any cardiovascular disease (i.e. ischemic heart disease, arrythmias, severe heart failure, untreated hypertension) - A first-degree family member with sudden cardiac death - Any chronic renal or hepatic disease - Abnormal laboratory values that could point towards underlying (metabolic, (auto)immune) disease and/or that could influence primary and secondary outcomes (e.g. dyslipidemia, leukopenia, abnormal liver function) - Abuse of alcohol (regularly more than 2 glasses per day) or use of any drugs - Smoking - Pregnancy - Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study - Use of any medication that may influence energy metabolism (e.g. ß-blockers, statins, antidepressants, antipsychotics), or may affect blood clotting (e.g. blood thinners). - Active cold water swimmers (at least once weekly during winter in the past 3 months) - Taking cold showers (in the past 3 months at least once weekly) - Participation in another research project Part 3 - Cold shower study Equal to part 2, but exclusion criterium is also male gender Part 4 - Implementation study Equal to part 2, but exclusion criterium is also male gender
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Thermal comfort and practicalities upon wearing either cooling vest for 5 days Part 2 and 3: Effects of cold exposure through wearing a cooling vest (part 1) or daily cold showers (part 2) on fat mass Part 4: Effects of cold exposure through wearing a cooling vest at fixed or flexible times on fat mass. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Resting energy expenditure upon wearing either cooling vest for 5 days Part 2 and 3: Cold-induced resting energy expenditure, lipid metabolism, hepatic steatosis, skin temperature, serum markers for glucose metabolism, immune cell phenotype and response of these cells to inflammatory stimuli, markers of biological stress, experienced stress and quality of life upon wearing a cooling vest for 2 h/day for 6 weeks or after daily cold showers Part 4: plasma lipid levels, serum markers for inflammation, glucose metabolism and experienced stress and quality of life | — |
Countries
Netherlands
Contacts
Public ContactMR Boon
Leids Universitair Medisch Centrum
Outcome results
None listed