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CompletedNCT03929198Prit-TNUpdated May 8, 2019

Translation of Pritikin Program to the Community

An interventional study of Healthy Lifestyle in Metabolic Syndrome, Obesity and Weight Loss, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-08.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2018, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Metabolic Syndrome
  • Obesity
  • Weight Loss
  • Hypertension
  • Hypercholesterolemia
  • Hypertriglyceridemia

Keywords

  • metabolic syndrome
  • obesity
03

In context

Metabolic Syndrome

2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.

This study's enrollment of 54 is close to the median of 60 across 1,494 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 270 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Positive exercise stress test
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Intervention

    The intervention group participated in a 6-week Pritikin diet, exercise program, and behavioral modification.

    Other: Healthy Lifestyle

  • No intervention
    Control

    This group did not receive any intervention.

Interventions

  • OtherHealthy Lifestyle

    6 week Diet, Exercise training, Behavioral modification

06

What researchers measure

Primary outcomes

  1. Body Weight

    Time frame: 6 weeks

  2. Blood Pressure

    Time frame: 6 weeks

  3. Cholesterol

    Time frame: 6 weeks

  4. Triglycerides

    Time frame: 6 weeks

07

Study locations

1 site
  • Washington University in St. Louis
    St Louis, Missouri 63110, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03929198
Collaborators
Pritikin Longevity Center, Wellmont Health System
Responsible party
Sponsor
First posted
Apr 26, 2019
Start date
Sep 27, 2018
Primary completion
Nov 20, 2018
Completion
Dec 1, 2018
Last update
May 8, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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