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Dietary Intervention and Vascular Function (DIVAS)

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ClinicalTrials.gov Identifier: NCT01478958
Recruitment Status : Completed
First Posted : November 23, 2011
Results First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Cardiovascular Disease
Interventions Dietary Supplement: SFA diet
Dietary Supplement: MUFA diet
Dietary Supplement: n-6 PUFA diet
Enrollment 202
Recruitment Details Recruited in three cohorts between November 2009 and June 2012.
Pre-assignment Details  
Arm/Group Title High Saturated Fat Diet High Monounsaturated Fat Diet High n-6 Polyunsaturated Fat Diet
Hide Arm/Group Description SFA diet: Volunteers followed a high saturated fat diet for a 4-month period MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
Period Title: Overall Study
Started 67 66 69
Completed 65 64 66
Not Completed 2 2 3
Reason Not Completed
Withdrawal by Subject             1             1             1
Weight loss             1             0             0
Re-located             0             1             0
Unable to comply             0             0             2
Arm/Group Title High Saturated Fat Diet High Monounsaturated Fat Diet High n-6 Polyunsaturated Fat Diet Total
Hide Arm/Group Description SFA diet: Volunteers followed a high saturated fat diet for a 4-month period MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period Total of all reporting groups
Overall Number of Baseline Participants 65 64 66 195
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 64 participants 66 participants 195 participants
45  (9) 43  (11) 45  (10) 44  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 66 participants 195 participants
Female
36
  55.4%
37
  57.8%
37
  56.1%
110
  56.4%
Male
29
  44.6%
27
  42.2%
29
  43.9%
85
  43.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 65 participants 64 participants 66 participants 195 participants
65 64 66 195
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 65 participants 64 participants 66 participants 195 participants
26.7  (4.4) 26.3  (3.9) 27.0  (3.7) 26.7  (4.0)
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 65 participants 64 participants 66 participants 195 participants
92.1  (12.1) 88.2  (10.3) 92.1  (13.1) 90.9  (12.0)
24-hour Systolic Blood Pressure (SBP)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 65 participants 64 participants 66 participants 195 participants
121  (12) 121  (10) 124  (11) 122  (11)
24-hour Diastolic Blood Pressure (DBP)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 65 participants 64 participants 66 participants 195 participants
75  (8) 74  (6) 76  (8) 75  (7)
Fasting Total Cholesterol (TC)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 65 participants 64 participants 66 participants 195 participants
5.38  (0.98) 5.43  (1.07) 5.57  (1.27) 5.46  (1.09)
Fasting High-Density Lipoprotein Cholesterol (HDL-C)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 65 participants 64 participants 66 participants 195 participants
1.45  (0.33) 1.48  (0.39) 1.51  (0.38) 1.48  (0.37)
Ratio of TC:HDL-C  
Mean (Standard Deviation)
Number Analyzed 65 participants 64 participants 66 participants 195 participants
3.92  (1.20) 3.85  (0.99) 3.85  (1.12) 3.87  (1.10)
Fasting Low-Density Lipoprotein Cholesterol (LDL-C)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 65 participants 64 participants 66 participants 195 participants
3.67  (0.93) 3.71  (0.88) 3.81  (1.13) 3.73  (0.98)
Fasting Triacylglycerol (TAG)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 65 participants 64 participants 66 participants 195 participants
1.31  (0.77) 1.18  (0.53) 1.26  (0.67) 1.25  (0.67)
Fasting Glucose  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 65 participants 64 participants 66 participants 195 participants
5.09  (0.43) 5.00  (0.45) 5.05  (0.44) 5.05  (0.44)
1.Primary Outcome
Title Percent Change in Flow Mediated Dilatation (FMD)
Hide Description [Not Specified]
Time Frame Baseline, 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed: n=171. n=24 were images of poor quality that could not be analyzed successfully.
Arm/Group Title High Saturated Fat Diet High Monounsaturated Fat Diet High n-6 Polyunsaturated Fat Diet
Hide Arm/Group Description:
SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
Overall Number of Participants Analyzed 59 57 55
Mean (Standard Error)
Unit of Measure: post-occlusion diameter change as %
-0.39  (0.24) -0.07  (0.32) -0.08  (0.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Saturated Fat Diet, High Monounsaturated Fat Diet, High n-6 Polyunsaturated Fat Diet
Comments To detect a 2% inter-group difference in FMD (primary outcome) using a SD of 2.3, 90% power and 5% significance level, n=171 participants were required (n=57 per group), increasing to n=228 to include a 25% dropout rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.238
Comments Overall diet effect. No post-hoc analyses required. Adjusted for multiple comparisons.
Method General Linear Model Univariate Analysis
Comments Baseline values for %FMD, BMI, age, gender and intervention diet used as prognostic factors in model.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Saturated Fat Diet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments Effect of the SFA-rich diet relative to baseline.
Method General Linear Model Univariate Analysis
Comments Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection High Monounsaturated Fat Diet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments Effect of MUFA-rich diet relative to baseline.
Method General Linear Model Univariate Analysis
Comments Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection High n-6 Polyunsaturated Fat Diet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments Effect of n-6 PUFA-rich diet relative to baseline.
Method General Linear Model Univariate Analysis
Comments Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.
2.Secondary Outcome
Title Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells)
Hide Description Data for fasting serum lipids (total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), TC:HDL-C ratio, low-density lipoprotein cholesterol (LDL-C), triacylglycerol (TAG)).
Time Frame 4 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title 24-hour Ambulatory Blood Pressure
Hide Description 24-hour, daytime and night-time measures of systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP; SBP-DBP) and heart rate (HR)
Time Frame 4 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP)
Hide Description PWV (m/s) PWA produces Augmentation Index (AIx; %) DVP produces Stiffness Index (SI; m/s) and Reflection Index (RI; %)
Time Frame 4 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis)
Hide Description Laser Doppler imaging (LDI) with iontophoresis of acetylcholine (Ach; endothelium-dependent vasodilation) and sodium nitroprusside (SNP; endothelium-independent vasodilation).
Time Frame 4 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Saturated Fat Diet High Monounsaturated Fat Diet High n-6 Polyunsaturated Fat Diet
Hide Arm/Group Description SFA diet: Volunteers followed a high saturated fat diet for a 4-month period MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
All-Cause Mortality
High Saturated Fat Diet High Monounsaturated Fat Diet High n-6 Polyunsaturated Fat Diet
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
High Saturated Fat Diet High Monounsaturated Fat Diet High n-6 Polyunsaturated Fat Diet
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   0/66 (0.00%)   0/69 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Saturated Fat Diet High Monounsaturated Fat Diet High n-6 Polyunsaturated Fat Diet
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   0/66 (0.00%)   0/69 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Professor Julie Lovegrove
Organization: University of Reading
Phone: +44 (0)118 3786418
EMail: j.a.lovegrove@reading.ac.uk
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Julie Lovegrove, University of Reading
ClinicalTrials.gov Identifier: NCT01478958    
Other Study ID Numbers: N02044
First Submitted: November 16, 2011
First Posted: November 23, 2011
Results First Submitted: May 13, 2014
Results First Posted: July 15, 2014
Last Update Posted: July 15, 2014