Sedentary Behavior Interrupted: A Trial of Acute Effects on Biomarkers of Healthy Aging

Sedentary Lifestyle Clinical Trial

Official title:

Sedentary Behavior Interrupted: A Randomized Crossover Trial of Acute Effects on Biomarkers of Healthy Aging in the Laboratory (Project 1)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03511352
• Other study ID #: 171547
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 8, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This protocol "Sedentary Behavior Interrupted: A randomized crossover trial of acute effects on biomarkers of healthy aging in the laboratory (Project 1)" is part of a National Institutes of Aging Program Grant called "Sedentary Time & Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 1 of the STAR program) is a 3-condition randomized crossover clinical trial of up to 86 postmenopausal women to test whether different interruptions to prolonged sitting improve metabolism.

Description:

The specific aims of this protocol include:

Aim 1. To investigate the acute effect of sitting interruption modalities on postprandial glucose and insulin concentrations, compared to prolonged sitting.

Aim 2. To investigate the acute effect of sitting interruption modalities on the physiologic parameters of endothelial function, compared to prolong sitting.

Aim 3. To explore the moderating effect of age.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• female

• 55 years of age and above

• any ethnicity or race

• screened to sit for 8 or more hours per day, perform less than 60 sit-to-stand transitions per day & engage in less than 20 minutes of moderate-to-vigorous physical activity (MVPA) per day

• BMI 25 - 45 kg/m2

• ambulatory

• medically stable without any health conditions that would inhibit standing or PA;

• able to give informed consent & comply with study protocols;

• able to read, communicate, and write fluently in English;

• able to travel to study visits;

• no menstruation for at least one year;

• not participating or not planning to participate in a physical activity or weight loss program or research study.

Exclusion Criteria:

• Mental state that would preclude complete understanding of the protocol or compliance;

• type 1 diabetes;

• type 2 diabetes using insulin or with poor glycemic control (greater than 10% for all participants);

• poorly controlled hypertension (Systolic Blood Pressure =165 or Diastolic Blood Pressure =100);

• chronic illness that may be associated with weight change (HIV/AIDS, active cancer, or uncontrolled thyroid disease),

• anemia (hemoglobin =11g/dL);

• personal or first-degree relative history of venous thrombosis;

• weight instability in past 3 months (no more than 5% up or down);

• regular use of vasodilator medication and high risk of stroke and/or heart attack (i.e., history of multiple hospitalizations (>2X) in the last 6 months), congestive heart failure, atrial fibrillation, and/or stroke;

• regular use of immunosuppressant or corticosteroid medication;

• blood donation less than 56 days prior to screening visit,

• smoking cigarettes or smoking or ingesting anything, and other use of tobacco products including e-cigarettes.

• diagnosis of orthostatic hypotension

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

Behavioral:
• Frequent sit-to-stands
Participants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including a 2-min stand every 15 min throughout the 5-hr protocol period. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed.
• Stand More
Participants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including 5 8-minute standing interruptions, 1 per hour. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed.

Locations

Country	Name	City	State
United States	UC San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glucose	To investigate the acute effect of sitting interruption modalities on postprandial glucose compared to prolonged sitting.	5 hours
Primary	Insulin	To investigate the acute effect of sitting interruption modalities on insulin concentrations compared to prolonged sitting.	5 hours
Secondary	Flow mediated dilation	To investigate the acute effect of sitting interruption modalities on flow mediated dilation compared to prolonged sitting	5 hours
Secondary	Blood pressure	To investigate the acute effect of sitting interruption modalities on blood pressure compared to prolonged sitting.	5 hours