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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03934723
Other study ID # 1423972-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 15, 2019
Est. completion date July 2020

Study information

Verified date July 2019
Source California State University, San Marcos
Contact Dean of Graduate Studies and Research
Phone (760) 750-4066
Email OGSR@csusm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Nearly one out of ten US adults over the age of 18 currently takes antidepressant medication, which can also treat other conditions such as anxiety. Combining pharmaceutical treatment with exercise may yield even greater benefits than using drugs alone, and this is commonly prescribed for depression. However, little is known about the drug-exercise interactions and their influence on metabolic health. A common side effect of antidepressant use is weight gain, particularly abdominal (visceral) fat, which is highly detrimental to overall health. Exercise is a well-known counter to abdominal fat accumulation. The aim of the proposed study is to compare the efficacy of 6 weeks of exercise training to reduce abdominal fat in healthy overweight/obese adults either taking or not taking antidepressant medication. Twenty-four inactive overweight/obese, but otherwise healthy, adults will complete 6 weeks of an exercise training intervention consisting of three days of aerobic exercise training per week. Participants will either not be taking antidepressant medication or will have been on their medication for at least 1 year. The primary outcome will be abdominal fat determined by waist circumference and dual x-ray absorptiometry, which is considered one of the optimal methods for assessment of abdominal fat.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date July 2020
Est. primary completion date July 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Participants will be English language speakers

- Male or females between the ages of 18-40.

- All genders and ethnicities.

- Healthy as assessed by a health history questionnaire (no diagnosed physical diseases or conditions preventing participation in exercise).

- Individuals on antidepressants will be recruited if they are consuming selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SNRIs) only. Participants will send prescription information after consent has been provided as part of the screening process, including the dose and frequency of medication.

- A body mass index (BMI) of 25 or greater is required for inclusion.

Exclusion Criteria:

- Inability to complete moderate-vigorous exercise.

- Taking first generation antidepressant medications or other medications such as monoamine oxidase inhibitors (MAOI).

- Other medications, such as medications for attention-deficit hyper-activity disorder or metabolism

- Undiagnosed depression that may be unveiled during the screening process.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
The intervention consists of 180 minutes of moderate-vigorous aerobic exercise per week for 6 weeks.

Locations

Country Name City State
United States California State University San Marcos San Marcos California

Sponsors (1)

Lead Sponsor Collaborator
California State University, San Marcos

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visceral adipose tissue (VAT) VAT assessed by dual-energy X-ray absorptiometry (DXA) Change from baseline after 6 weeks.
Primary Waist circumference Waist circumference is a proxy of VAT Change from baseline after 6 weeks.
Secondary Aerobic fitness Fitness assessed via a maximal treadmill exercise test Change from baseline after 6 weeks.
Secondary Blood pressure Resting blood pressure assessed with an oscillatory blood pressure monitor Change from baseline after 6 weeks.
Secondary Blood glucose Fasting capillary glucose sample Change from baseline after 6 weeks.
Secondary Blood lipid panel Fasting capillary blood sample for triglycerides and cholesterol Change from baseline after 6 weeks.
Secondary Body mass Body mass measured on a scale Change from baseline after 6 weeks.
Secondary Fat mass Total and segmental body fat mass measured by DXA Change from baseline after 6 weeks.
Secondary Lean mass Total and segmental lean mass measured by DXA Change from baseline after 6 weeks.
Secondary Dietary intake Food logs recorded over two week days and one weekend day Change from baseline after 6 weeks.
Secondary Physical activity Free-living physical activity assessed over 7 days via combined heart-rate and accelerometry Change from baseline after 6 weeks.
Secondary Depression symptoms Symptoms of depression assessed with Beck's Depression Inventory (BDI). The BDI is a 21-item questionnaire that measures total depressive symptoms. Individual item scores range from 0-3. Individual items are then summed to provide a total score, ranging from 0 to 63. Change from baseline after 6 weeks.
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