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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mild Hypercholesterolemia | Dietary Supplement: whole apples (WA) Dietary Supplement: apple juice (AJ) | Not Applicable |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 23 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
United Kingdom | |
Department of Food and Nutritional Sciences, University of Reading | |
Reading, Berkshire, United Kingdom, RG6 6AP |
Principal Investigator: | Julie A Lovegrove, BSc, PhD, RNutr | University of Reading | |
Principal Investigator: | Kieran Tuohy, Dr | FEM-IASMA Research and Innovation centre |
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 |
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |