Short-term effects of apple consumption on vascular health

Not Applicable

Completed

• Conditions: Cardiovascular disease; Cardiovascular - Coronary heart disease; Cardiovascular - Hypertension; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12618000269235
• Lead Sponsor: Edith Cowan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-21
• Study Completion: 2018-10-26
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Men and women will be aged between 18 and 75 years
Volunteers are included in the study if they have at least one of the following: elevated blood pressure (120 mmHg< systolic BP <150 mmHg), moderately elevated blood sugar levels (5.6 mmol/L< glucose <6.5 mmol/L), raised fasting cholesterol (5 mmol/L < total cholesterol <8 mmol/L) or central obesity (measured by waist circumference; men >94 cm; women >80 cm).

Exclusion Criteria

•Body mass index <18 or >40 kg/m2
•Systolic blood pressure greater than or equal to 150 mmHg
•Diastolic BP greater than or equal to 100 mmHg
•Diagnosed diabetes
•Non-diabetic individuals with fasting plasma glucose concentrations greater than or equal to 6.5 mmol/L
•Current or recent (<12 months) smoking
•History of cardiovascular or peripheral vascular disease
•Use of blood pressure lowering or cholesterol lowering medication
•Psychiatric illness or other major illnesses such as cancer
•Alcohol intake >210 g per week for women and >280 g per week for men
•Current or recent (within previous 6 months) significant weight loss or gain (>6% of body weight) or actively trying to lose weight
•Women who were lactating, pregnant or wishing to become pregnant during the study.
•Inability to attend clinic/office visits
•Use of antibiotics (within previous 2 months)
•current or recent (<6 months) smoking
•Inability or unwillingness to follow the study protocol
•Systolic blood pressure less than or equal to 100 mmHg
•Diastolic BP less than or equal to50 mmHg

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endothelial function will be measured by using ultrasound by flow-mediated dilation (FMD) of the brachial artery[Beginning and end of each 4 week intervention period]

Secondary Outcome Measures

Name	Time	Method
Measurement of the faecal microflora (microbiome) by 16s rRNA sequencing[End of each baseline/washout period and during the final week of the two intervention periods];Blood pressure will be measured at home using an upper arm portable sphygmomanometer[Daily for 7 days at the end of each baseline/washout period and during the final week of the two intervention periods];Arterial stiffness will be measured by pulse wave velocity and augmentation index[Beginning and end of each 4 week intervention period];Circulating biomarkers of nitric oxide metabolism (plasma nitrate, nitrite and s-nitrosothiols) measured using chemiluminescence and GCMS. [Beginning and end of each 4 week intervention period];Faecal short-chain fatty acids measured using GCMS. [Beginning and end of each 4-week intervention period];Plasma short-chain fatty acids measured using GCMS. [Beginning and end of each 4-week intervention period]