Cold as a therapeutic strategy to improve cardiovascular risk factors
- Conditions
- cardiovascular diseases100110821001842410013317
- Registration Number
- NL-OMON56482
- Lead Sponsor
- niversitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 168
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
- 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
males and females with Europid ethnicity will be included.
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 & 3 - Cooling vest and cold shower 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. β-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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part 1: Thermal comfort and practicalities upon wearing either cooling vest for<br /><br>5 days<br /><br>Part 2 and 3: Effects of cold exposure through wearing a cooling vest (part 1)<br /><br>or daily cold showers (part 2) on fat mass </p><br>
- Secondary Outcome Measures
Name Time Method <p>Part 1: Resting energy expenditure upon wearing either cooling vest for 5 days<br /><br>Part 2 and 3: Cold-induced resting energy expenditure, lipid metabolism,<br /><br>hepatic steatosis, skin temperature, serum markers for glucose metabolism,<br /><br>immune cell phenotype and response of these cells to inflammatory stimuli,<br /><br>markers of biological stress, experienced stress and quality of life upon<br /><br>wearing a cooling vest for 2 h/day for 6 weeks or after daily cold showers</p><br>