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

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

Tracking Information

• First Submitted Date: October 10, 2013
• First Posted Date: November 20, 2013
• Last Update Posted Date: March 9, 2015
• Study Start Date: September 2013
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 11, 2013): Changes in blood lipid levels [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm including a 4 week wash out period. ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 11, 2013)

• Evaluation of endothelial function by using laser doppler iontophoresis (LDI) [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm. ]
• Changes in vascular stiffness by pulse wave analysis (PWA) [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm ]
• Changes in faecal bacterial population [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm ]
• 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
• Changes in inflammatory, endothelial function and oxidative stress markers [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm ]
• Changes in insulin resistance and gut hormones [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Apples on cardioVascular Risk And Gut Health
• Official Title: Effect of Apples Consumption on Blood Lipid Levels,Vascular Function and Gut Health in Moderate Hypercholesterolemic Subjects
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Mild Hypercholesterolemia

Intervention

• Dietary Supplement: whole apples (WA)
• Dietary Supplement: apple juice (AJ)

Study Arms

• Experimental: whole apples
  Subjects are asked to consume 2 apples a day for 8 weeks in addition to their habitual diet
  Intervention: 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.
  Intervention: Dietary Supplement: apple juice (AJ)

• Publications *: Koutsos A, Riccadonna S, Ulaszewska MM, Franceschi P, Trošt K, Galvin A, Braune T, Fava F, Perenzoni D, Mattivi F, Tuohy KM, Lovegrove JA. Two apples a day lower serum cholesterol and improve cardiometabolic biomarkers in mildly hypercholesterolemic adults: a randomized, controlled, crossover trial. Am J Clin Nutr. 2020 Feb 1;111(2):307-318. doi: 10.1093/ajcn/nqz282.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 11, 2013): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2014
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 23 Years to 69 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01988389
• Other Study ID Numbers: 13/22; University of Reading
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Julie Lovegrove, University of Reading
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Reading
• Original Study Sponsor: Same as current
• Collaborators: Fondazione Edmund Mach di San Michele all'Adige

Investigators

• Principal Investigator: Julie A Lovegrove, BSc, PhD, RNutr; University of Reading
• Principal Investigator: Kieran Tuohy, Dr; FEM-IASMA Research and Innovation centre

• PRS Account: University of Reading
• Verification Date: March 2015