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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03929198
Other study ID # 1204508
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 27, 2018
Est. completion date December 1, 2018

Study information

Verified date May 2019
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The broad, long-term aims of this scope of work are to investigate the effects of the Pritikin Program to the general population. The study will test the effects on individuals from the community with dysfunctional lipids, blood pressure and glycemic control. To assess the effectiveness of the Pritikin Program in the community, the effects of Pritikin lifestyle intervention on overall health will be investigated.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 1, 2018
Est. primary completion date November 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Dysfunctional lipids, blood pressure and glycemic control determined at a screening visit:

- Triglycerides > 150 mg/dL OR HDL <50 in females, <40 mg/dL in males

- Systolic blood pressure =130 mmHg OR diastolic blood pressure =80 mmHg (or on hypertension medication)

- HbA1c =5.7% or higher

- No diagnosis or treatment for cancer in the past year

- No diagnosis of mild cognitive impairment or dementia in the past year

- Ability to perform daily exercise, including aerobic activity and resistance exercise

- Non-smoker in the past year

Exclusion Criteria:

- Positive exercise stress test

Study Design


Intervention

Other:
Healthy Lifestyle
6 week Diet, Exercise training, Behavioral modification

Locations

Country Name City State
United States Washington University in St. Louis Saint Louis Missouri

Sponsors (3)

Lead Sponsor Collaborator
Washington University School of Medicine Pritikin Longevity Center, Wellmont Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Weight 6 weeks
Primary Blood Pressure 6 weeks
Primary Cholesterol 6 weeks
Primary Triglycerides 6 weeks
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