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Low Fat Vegan Diet or American Heart Association Diet Impact on Cardiovascular Risk in Obese Hypercholesterolemic 9-18 y.o.

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ClinicalTrials.gov Identifier: NCT01817491
Recruitment Status : Completed
First Posted : March 25, 2013
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
michael macknin, The Cleveland Clinic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Cardiovascular Disease
Hypercholesterolemia
Obesity
Fatty Liver
Interventions: Other: American Heart Association Diet
Other: Reduced Fat Vegan Diet

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Reduced Fat Vegan Diet

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

American Heart Association Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet


Participant Flow:   Overall Study
    Reduced Fat Vegan Diet   American Heart Association Diet
STARTED   32   28 
COMPLETED   28   28 
NOT COMPLETED   4   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Reduced Fat Vegan Diet

Plant based diet with as few added oils and fats as possible.

Reduced Fat Vegan Diet

American Heart Association Diet

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

American Heart Association Diet

Total Total of all reporting groups

Baseline Measures
   Reduced Fat Vegan Diet   American Heart Association Diet   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   28   60 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      16  50.0%      14  50.0%      30  50.0% 
Between 18 and 65 years      16  50.0%      14  50.0%      30  50.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
     
Adolescents   15 
 (9.0 to 18.0) 
 15 
 (9.0 to 18.0) 
 15 
 (9.0 to 18.0) 
Parents   46.5 
 (37.0 to 61.0) 
 46.0 
 (35.0 to 51.0) 
 46.25 
 (35.0 to 61.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      21  65.6%      19  67.9%      40  66.7% 
Male      11  34.4%      9  32.1%      20  33.3% 
Region of Enrollment 
[Units: Participants]
     
United States   32   28   60 


  Outcome Measures

1.  Primary:   Change in Body Mass Index BMI Percentile   [ Time Frame: baseline, 4 weeks ]

2.  Primary:   Children Change in BMI Z Score   [ Time Frame: baseline, 4 weeks ]

3.  Primary:   Change in Blood Pressure (BP)   [ Time Frame: baseline, 4 weeks ]

4.  Primary:   Change in Weight   [ Time Frame: baseline, 4 weeks ]

5.  Primary:   Change in Circumference   [ Time Frame: baseline, 4 weeks ]

6.  Primary:   Change in PAQ (Physical Activity Questionnaire)   [ Time Frame: baseline, 4 weeks ]

7.  Primary:   Change in Lipid Profile   [ Time Frame: baseline, 4 weeks ]

8.  Primary:   Change in Glucose   [ Time Frame: baseline, 4 weeks ]

9.  Primary:   Change in hsCRP (High-sensitivity C-reactive Protein)   [ Time Frame: baseline, 4 weeks ]

10.  Primary:   Change in Liver Enzymes   [ Time Frame: baseline, 4 weeks ]

11.  Primary:   Change in IL-6 (Interleukin-6)   [ Time Frame: baseline, 4 weeks ]

12.  Primary:   Change in MPO (Myeloperoxidase)   [ Time Frame: baseline, 4 weeks ]

13.  Primary:   Change in HgbA1c (Hemoglobin A1c)   [ Time Frame: baseline, 4 weeks ]

14.  Primary:   Change in Insulin   [ Time Frame: baseline, 4 weeks ]

15.  Secondary:   PB/AHA - Adjusted Mean Difference BMI   [ Time Frame: Baseline, 4 weeks ]

16.  Secondary:   PB/AHA - Adjusted Mean Difference BMI Z Score Children   [ Time Frame: Baseline, 4 weeks ]

17.  Secondary:   PB/AHA - Adjusted Mean BP   [ Time Frame: Baseline, 4 weeks ]

18.  Secondary:   PB/AHA - Adjusted Mean Difference Weight   [ Time Frame: Baseline, 4 weeks ]

19.  Secondary:   PB/AHA - Adjusted Mean Difference Circumference   [ Time Frame: Baseline, 4 weeks ]

20.  Secondary:   PB/AHA - Adjusted Mean Difference PAQ Children   [ Time Frame: Baseline, 4 weeks ]

21.  Secondary:   PB/AHA - Adjusted Mean Lipid Profile   [ Time Frame: Baseline, 4 weeks ]

22.  Secondary:   PB/AHA - Adjusted Mean Ratio Glucose   [ Time Frame: Baseline, 4 weeks ]

23.  Secondary:   PB/AHA - Adjusted Mean Ratio hsCRP   [ Time Frame: Baseline, 4 weeks ]

24.  Secondary:   PB/AHA - Adjusted Mean Ratio Liver Enzymes   [ Time Frame: Baseline, 4 weeks ]

25.  Secondary:   PB/AHA - Adjusted Mean Ratio IL-6   [ Time Frame: Baseline, 4 weeks ]

26.  Secondary:   PB/AHA - Adjusted Mean Ratio MPO   [ Time Frame: Baseline, 4 weeks ]

27.  Secondary:   PB/AHA - Adjusted Mean Ratio HgbA1c   [ Time Frame: Baseline, 4 weeks ]

28.  Secondary:   PB/AHA - Adjusted Mean Ratio Insulin   [ Time Frame: Baseline, 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael Macknin, MD
Organization: Cleveland Clinic
phone: 216 444-5512
e-mail: macknim@ccf.org


Publications:
Esselstyn R. The Engine 2 Diet How It All Began. In Esselstyn R "The Engine 2 Diet". New York, Boston: Wellness Central Hachette Book Group, 2009:15-30

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: michael macknin, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01817491     History of Changes
Other Study ID Numbers: 12-1298
First Submitted: March 21, 2013
First Posted: March 25, 2013
Results First Submitted: January 11, 2017
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018