NCT03929198

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

April 24, 2019

Last Update Submit

May 6, 2019

Conditions

Metabolic SyndromeObesityWeight LossHypertensionHypercholesterolemiaHypertriglyceridemia

Keywords

metabolic syndromeobesity

Outcome Measures

Primary Outcomes (4)

  • Body Weight

    6 weeks

  • Blood Pressure

    6 weeks

  • Cholesterol

    6 weeks

  • Triglycerides

    6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Healthy Lifestyle

Control

NO INTERVENTION

This group did not receive any intervention.

Interventions

Healthy LifestyleOTHER

6 week Diet, Exercise training, Behavioral modification

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Positive exercise stress test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeObesityWeight LossHypertensionHypercholesterolemiaHypertriglyceridemia

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesVascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 26, 2019

Study Start

September 27, 2018

Primary Completion

November 20, 2018

Study Completion

December 1, 2018

Last Updated

May 8, 2019

Record last verified: 2019-05

Locations

US(1)