Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 10, 2013
First Posted Date  ICMJE November 20, 2013
Last Update Posted Date March 9, 2015
Study Start Date  ICMJE September 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Apples on cardioVascular Risk And Gut Health
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Mild Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: whole apples (WA)
  • Dietary Supplement: apple juice (AJ)
Study Arms  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 23 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01988389
Other Study ID Numbers  ICMJE 13/22
University of Reading
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie Lovegrove, University of Reading
Study Sponsor  ICMJE University of Reading
Collaborators  ICMJE Fondazione Edmund Mach di San Michele all'Adige
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP