Dietary Intervention and Vascular Function (DIVAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading
ClinicalTrials.gov Identifier:
NCT01478958
First received: November 16, 2011
Last updated: June 12, 2014
Last verified: June 2014
Results First Received: May 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Cardiovascular Disease
Interventions: Dietary Supplement: SFA diet
Dietary Supplement: MUFA diet
Dietary Supplement: n-6 PUFA diet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited in three cohorts between November 2009 and June 2012.

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
High Saturated Fat Diet SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
High Monounsaturated Fat Diet MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
High n-6 Polyunsaturated Fat Diet n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period

Participant Flow:   Overall Study
    High Saturated Fat Diet     High Monounsaturated Fat Diet     High n-6 Polyunsaturated Fat Diet  
STARTED     67     66     69  
COMPLETED     65     64     66  
NOT COMPLETED     2     2     3  
Withdrawal by Subject                 1                 1                 1  
Weight loss                 1                 0                 0  
Re-located                 0                 1                 0  
Unable to comply                 0                 0                 2  



  Baseline Characteristics
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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
High Saturated Fat Diet SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
High Monounsaturated Fat Diet MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
High n-6 Polyunsaturated Fat Diet n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
Total Total of all reporting groups

Baseline Measures
    High Saturated Fat Diet     High Monounsaturated Fat Diet     High n-6 Polyunsaturated Fat Diet     Total  
Number of Participants  
[units: participants]
  65     64     66     195  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 9     43  ± 11     45  ± 10     44  ± 10  
Gender  
[units: participants]
       
Female     36     37     37     110  
Male     29     27     29     85  
Region of Enrollment  
[units: participants]
       
United Kingdom     65     64     66     195  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  26.7  ± 4.4     26.3  ± 3.9     27.0  ± 3.7     26.7  ± 4.0  
Waist Circumference  
[units: cm]
Mean ± Standard Deviation
  92.1  ± 12.1     88.2  ± 10.3     92.1  ± 13.1     90.9  ± 12.0  
24-hour Systolic Blood Pressure (SBP)  
[units: mm Hg]
Mean ± Standard Deviation
  121  ± 12     121  ± 10     124  ± 11     122  ± 11  
24-hour Diastolic Blood Pressure (DBP)  
[units: mm Hg]
Mean ± Standard Deviation
  75  ± 8     74  ± 6     76  ± 8     75  ± 7  
Fasting Total Cholesterol (TC)  
[units: mmol/L]
Mean ± Standard Deviation
  5.38  ± 0.98     5.43  ± 1.07     5.57  ± 1.27     5.46  ± 1.09  
Fasting High-Density Lipoprotein Cholesterol (HDL-C)  
[units: mmol/L]
Mean ± Standard Deviation
  1.45  ± 0.33     1.48  ± 0.39     1.51  ± 0.38     1.48  ± 0.37  
Ratio of TC:HDL-C  
[units: none]
Mean ± Standard Deviation
  3.92  ± 1.20     3.85  ± 0.99     3.85  ± 1.12     3.87  ± 1.10  
Fasting Low-Density Lipoprotein Cholesterol (LDL-C)  
[units: mmol/L]
Mean ± Standard Deviation
  3.67  ± 0.93     3.71  ± 0.88     3.81  ± 1.13     3.73  ± 0.98  
Fasting Triacylglycerol (TAG)  
[units: mmol/L]
Mean ± Standard Deviation
  1.31  ± 0.77     1.18  ± 0.53     1.26  ± 0.67     1.25  ± 0.67  
Fasting Glucose  
[units: mmol/L]
Mean ± Standard Deviation
  5.09  ± 0.43     5.00  ± 0.45     5.05  ± 0.44     5.05  ± 0.44  



  Outcome Measures

1.  Primary:   Percent Change in Flow Mediated Dilatation (FMD)   [ Time Frame: Baseline, 4 months ]

2.  Secondary:   Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells)   [ Time Frame: 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   24-hour Ambulatory Blood Pressure   [ Time Frame: 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP)   [ Time Frame: 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis)   [ Time Frame: 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Professor Julie Lovegrove
Organization: University of Reading
phone: +44 (0)118 3786418
e-mail: j.a.lovegrove@reading.ac.uk


No publications provided by University of Reading

Publications automatically indexed to this study:

Responsible Party: Julie Lovegrove, University of Reading
ClinicalTrials.gov Identifier: NCT01478958     History of Changes
Other Study ID Numbers: N02044
Study First Received: November 16, 2011
Results First Received: May 13, 2014
Last Updated: June 12, 2014
Health Authority: United Kingdom: Food Standards Agency and Department of Health