Effect of Apples on cardioVascular Risk And Gut Health

Mild Hypercholesterolemia Clinical Trial

— AVAG  

Official title:

Effect of Apples Consumption on Blood Lipid Levels,Vascular Function and Gut Health in Moderate Hypercholesterolemic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988389
• Other study ID #: 13/22
• Secondary ID: University of Re
• Status: Completed
• Phase: N/A
• First received: October 10, 2013
• Last updated: March 6, 2015
• Start date: September 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: University Research Ethics Committee, University of Reading: UK
• Study type: Interventional

Clinical Trial Summary

There is now considerable scientific evidence that a diet rich in fruits and vegetables could improve human health. Apples are among the most frequently consumed fruits in the world. Epidemiological studies have linked frequent apple consumption with several health benefits including a reduced risk of cardiovascular disease. Apples are an important source of polyphenols and fiber and their beneficial effects could be attributed to this content; however, their impact on our health is not clear. Although, there are some studies that have reported cholesterol lowering effects the results are inconsistent. Furthermore, few studies have explored the impact on vascular function and gut microbiota. The objective of the current study is to assess whether a regular apple consumption, reduces total cholesterol levels, improves vascular function and gut microbiota profile in mildly hypercholesterolemic subjects compared with a control, sugar matched commercial clear apple juice squash.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 69 Years

Eligibility

Inclusion Criteria:

• Mildly hypercholesterolemic: TC>5.2 and <7.9 mmol/L

• BMI: 20-35

• Age: 23-69

• Normal liver and kidney function

Exclusion Criteria:

• Drug treatment for hyperlipidaemia, hypertension, inflammation and hypercoagulation.

• Vegetarians.

• Smoking.

• History of alcohol misuse.

• History of food allergy (e.g. apples, sulphites).

• Taking antibiotics for the previous 3 months.

• Taking phytochemical, antioxidant, fish oil supplements, or prebiotic/probiotic preparations unless willing to stop for the study period and after a 4 week wash out period (8 weeks for fish oil).

• Females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence).

• Medical history of cardiovascular disease including coronary heart disease (angina and heart attack) and stroke (in the past 12 months).

• Family history of cardiovascular disease (their father or brother was under 55 or their mother or sister was under 65 when they were diagnosed with cardiovascular disease).

• Diabetes mellitus.

• Kidney, liver, pancreas or gastrointestinal diseases.

• Hematologic disorders (i.e. anaemia; men:haemoglobin<13.8g/dl (8.56mmol/L) and women<12.1 g/dl (5.51mmol/L)).

• Planning a weight reducing regime.

• Parallel participation in another dietary intervention study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypercholesterolemia
• Mild Hypercholesterolemia

Intervention

Dietary Supplement:
• whole apples (WA)

• apple juice (AJ)

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences, University of Reading	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	Fondazione Edmund Mach di San Michele all'Adige

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in blood lipid levels		Baseline and assessment at 8 weeks for each intervention arm including a 4 week wash out period.	No
Secondary	Evaluation of endothelial function by using laser doppler iontophoresis (LDI)		Baseline and assessment at 8 weeks for each intervention arm.	No
Secondary	Changes in vascular stiffness by pulse wave analysis (PWA)		Baseline and assessment at 8 weeks for each intervention arm	No
Secondary	Changes in faecal bacterial population		Baseline and assessment at 8 weeks for each intervention arm	No
Secondary	Ambulatory blood pressure	Blood pressure will be recorded for 30 minutes at baseline and at 8 weeks for each intervention arm	Baseline and assessment at 8 weeks for each intervention arm	No
Secondary	Changes in inflammatory, endothelial function and oxidative stress markers		Baseline and assessment at 8 weeks for each intervention arm	No
Secondary	Changes in insulin resistance and gut hormones		Baseline and assessment at 8 weeks for each intervention arm	No
Secondary	Metabolomic analysis for the determination of the low molecular weight metabolite profiles in the biological fluids (blood, urine and faecal sample).		Baseline and assessment at 8 weeks for each intervention arm	No