Trial Outcomes & Findings for Dietary Intervention and Vascular Function (NCT NCT01478958)

NCT ID: NCT01478958

Last Updated: 2014-07-15

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

202 participants

Primary outcome timeframe

Baseline, 4 months

Results posted on

2014-07-15

Participant Flow

Recruited in three cohorts between November 2009 and June 2012.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	67	66	69
Overall Study COMPLETED	65	64	66
Overall Study NOT COMPLETED	2	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	1	1	1
Overall Study Weight loss	1	0	0
Overall Study Re-located	0	1	0
Overall Study Unable to comply	0	0	2

Baseline Characteristics

Dietary Intervention and Vascular Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Saturated Fat Diet n=65 Participants SFA diet: Volunteers followed a high saturated fat diet for a 4-month period	High Monounsaturated Fat Diet n=64 Participants MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period	High n-6 Polyunsaturated Fat Diet n=66 Participants n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period	Total n=195 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 9 • n=93 Participants	43 years STANDARD_DEVIATION 11 • n=4 Participants	45 years STANDARD_DEVIATION 10 • n=27 Participants	44 years STANDARD_DEVIATION 10 • n=483 Participants
Sex: Female, Male Female	36 Participants n=93 Participants	37 Participants n=4 Participants	37 Participants n=27 Participants	110 Participants n=483 Participants
Sex: Female, Male Male	29 Participants n=93 Participants	27 Participants n=4 Participants	29 Participants n=27 Participants	85 Participants n=483 Participants
Region of Enrollment United Kingdom	65 participants n=93 Participants	64 participants n=4 Participants	66 participants n=27 Participants	195 participants n=483 Participants
Body Mass Index (BMI)	26.7 kg/m^2 STANDARD_DEVIATION 4.4 • n=93 Participants	26.3 kg/m^2 STANDARD_DEVIATION 3.9 • n=4 Participants	27.0 kg/m^2 STANDARD_DEVIATION 3.7 • n=27 Participants	26.7 kg/m^2 STANDARD_DEVIATION 4.0 • n=483 Participants
Waist Circumference	92.1 cm STANDARD_DEVIATION 12.1 • n=93 Participants	88.2 cm STANDARD_DEVIATION 10.3 • n=4 Participants	92.1 cm STANDARD_DEVIATION 13.1 • n=27 Participants	90.9 cm STANDARD_DEVIATION 12.0 • n=483 Participants
24-hour Systolic Blood Pressure (SBP)	121 mm Hg STANDARD_DEVIATION 12 • n=93 Participants	121 mm Hg STANDARD_DEVIATION 10 • n=4 Participants	124 mm Hg STANDARD_DEVIATION 11 • n=27 Participants	122 mm Hg STANDARD_DEVIATION 11 • n=483 Participants
24-hour Diastolic Blood Pressure (DBP)	75 mm Hg STANDARD_DEVIATION 8 • n=93 Participants	74 mm Hg STANDARD_DEVIATION 6 • n=4 Participants	76 mm Hg STANDARD_DEVIATION 8 • n=27 Participants	75 mm Hg STANDARD_DEVIATION 7 • n=483 Participants
Fasting Total Cholesterol (TC)	5.38 mmol/L STANDARD_DEVIATION 0.98 • n=93 Participants	5.43 mmol/L STANDARD_DEVIATION 1.07 • n=4 Participants	5.57 mmol/L STANDARD_DEVIATION 1.27 • n=27 Participants	5.46 mmol/L STANDARD_DEVIATION 1.09 • n=483 Participants
Fasting High-Density Lipoprotein Cholesterol (HDL-C)	1.45 mmol/L STANDARD_DEVIATION 0.33 • n=93 Participants	1.48 mmol/L STANDARD_DEVIATION 0.39 • n=4 Participants	1.51 mmol/L STANDARD_DEVIATION 0.38 • n=27 Participants	1.48 mmol/L STANDARD_DEVIATION 0.37 • n=483 Participants
Ratio of TC:HDL-C	3.92 (MEAN) STANDARD_DEVIATION 1.20 • n=93 Participants	3.85 (MEAN) STANDARD_DEVIATION 0.99 • n=4 Participants	3.85 (MEAN) STANDARD_DEVIATION 1.12 • n=27 Participants	3.87 (MEAN) STANDARD_DEVIATION 1.10 • n=483 Participants
Fasting Low-Density Lipoprotein Cholesterol (LDL-C)	3.67 mmol/L STANDARD_DEVIATION 0.93 • n=93 Participants	3.71 mmol/L STANDARD_DEVIATION 0.88 • n=4 Participants	3.81 mmol/L STANDARD_DEVIATION 1.13 • n=27 Participants	3.73 mmol/L STANDARD_DEVIATION 0.98 • n=483 Participants
Fasting Triacylglycerol (TAG)	1.31 mmol/L STANDARD_DEVIATION 0.77 • n=93 Participants	1.18 mmol/L STANDARD_DEVIATION 0.53 • n=4 Participants	1.26 mmol/L STANDARD_DEVIATION 0.67 • n=27 Participants	1.25 mmol/L STANDARD_DEVIATION 0.67 • n=483 Participants
Fasting Glucose	5.09 mmol/L STANDARD_DEVIATION 0.43 • n=93 Participants	5.00 mmol/L STANDARD_DEVIATION 0.45 • n=4 Participants	5.05 mmol/L STANDARD_DEVIATION 0.44 • n=27 Participants	5.05 mmol/L STANDARD_DEVIATION 0.44 • n=483 Participants

PRIMARY outcome

Timeframe: Baseline, 4 months

Population: Number of participants analyzed: n=171. n=24 were images of poor quality that could not be analyzed successfully.

Outcome measures

Outcome measures
Measure	High Saturated Fat Diet n=59 Participants SFA diet: Volunteers followed a high saturated fat diet for a 4-month period	High Monounsaturated Fat Diet n=57 Participants MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period	High n-6 Polyunsaturated Fat Diet n=55 Participants n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
Percent Change in Flow Mediated Dilatation (FMD)	-0.39 post-occlusion diameter change as % Standard Error 0.24	-0.07 post-occlusion diameter change as % Standard Error 0.32	-0.08 post-occlusion diameter change as % Standard Error 0.31

SECONDARY outcome

Timeframe: 4 months

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)).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months

PWV (m/s) PWA produces Augmentation Index (AIx; %) DVP produces Stiffness Index (SI; m/s) and Reflection Index (RI; %)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months

Laser Doppler imaging (LDI) with iontophoresis of acetylcholine (Ach; endothelium-dependent vasodilation) and sodium nitroprusside (SNP; endothelium-independent vasodilation).

Outcome measures

Outcome data not reported

Adverse Events

High Saturated Fat Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Monounsaturated Fat Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High n-6 Polyunsaturated Fat Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Julie Lovegrove

University of Reading

Phone: +44 (0)118 3786418

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place