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Effect of Apples on cardioVascular Risk And Gut Health (AVAG)

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ClinicalTrials.gov Identifier: NCT01988389
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : March 9, 2015
Sponsor:
Collaborator:
Fondazione Edmund Mach di San Michele all'Adige
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Mild Hypercholesterolemia Dietary Supplement: whole apples (WA) Dietary Supplement: apple juice (AJ) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Apples Consumption on Blood Lipid Levels,Vascular Function and Gut Health in Moderate Hypercholesterolemic Subjects
Study Start Date : September 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: whole apples
Subjects are asked to consume 2 apples a day for 8 weeks in addition to their habitual diet
 Dietary Supplement: whole apples (WA)
apple juice squash
Subjects are asked to consume 100 ml of apple juice squash (recommended dilution with water up to 500 ml) for 8 weeks in addition to their habitual diet. The apple juice is used as a sugar matched control.
 Dietary Supplement: apple juice (AJ)


Outcome Measures
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Primary Outcome Measures :
  1. Changes in blood lipid levels [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm including a 4 week wash out period. ]

Secondary Outcome Measures :
  1. Evaluation of endothelial function by using laser doppler iontophoresis (LDI) [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm. ]
  2. Changes in vascular stiffness by pulse wave analysis (PWA) [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm ]
  3. Changes in faecal bacterial population [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm ]
  4. Ambulatory blood pressure [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm ]
    Blood pressure will be recorded for 30 minutes at baseline and at 8 weeks for each intervention arm

  5. Changes in inflammatory, endothelial function and oxidative stress markers [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm ]
  6. Changes in insulin resistance and gut hormones [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm ]
  7. Metabolomic analysis for the determination of the low molecular weight metabolite profiles in the biological fluids (blood, urine and faecal sample). [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm ]

Eligibility Criteria
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Ages Eligible for Study:   23 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988389


Locations
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United Kingdom
Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Fondazione Edmund Mach di San Michele all'Adige
Investigators
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Principal Investigator: Julie A Lovegrove, BSc, PhD, RNutr University of Reading
Principal Investigator: Kieran Tuohy, Dr FEM-IASMA Research and Innovation centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Julie Lovegrove, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT01988389    
Other Study ID Numbers: 13/22
University of Reading
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases