search
Back to results

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

Primary Purpose

Mild Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
whole apples (WA)
apple juice (AJ)
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Hypercholesterolemia

Eligibility Criteria

23 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Food and Nutritional Sciences, University of Reading

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

whole apples

apple juice squash

Arm Description

Subjects are asked to consume 2 apples a day for 8 weeks in addition to their habitual diet

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.

Outcomes

Primary Outcome Measures

Changes in blood lipid levels

Secondary Outcome Measures

Evaluation of endothelial function by using laser doppler iontophoresis (LDI)
Changes in vascular stiffness by pulse wave analysis (PWA)
Changes in faecal bacterial population
Ambulatory blood pressure
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
Changes in insulin resistance and gut hormones
Metabolomic analysis for the determination of the low molecular weight metabolite profiles in the biological fluids (blood, urine and faecal sample).

Full Information

First Posted
October 10, 2013
Last Updated
March 6, 2015
Sponsor
University of Reading
Collaborators
Fondazione Edmund Mach di San Michele all'Adige
search

1. Study Identification

Unique Protocol Identification Number
NCT01988389
Brief Title
Effect of Apples on cardioVascular Risk And Gut Health
Acronym
AVAG
Official Title
Effect of Apples Consumption on Blood Lipid Levels,Vascular Function and Gut Health in Moderate Hypercholesterolemic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading
Collaborators
Fondazione Edmund Mach di San Michele all'Adige

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Hypercholesterolemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
whole apples
Arm Type
Experimental
Arm Description
Subjects are asked to consume 2 apples a day for 8 weeks in addition to their habitual diet
Arm Title
apple juice squash
Arm Type
Other
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
whole apples (WA)
Intervention Type
Dietary Supplement
Intervention Name(s)
apple juice (AJ)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluation of endothelial function by using laser doppler iontophoresis (LDI)
Time Frame
Baseline and assessment at 8 weeks for each intervention arm.
Title
Changes in vascular stiffness by pulse wave analysis (PWA)
Time Frame
Baseline and assessment at 8 weeks for each intervention arm
Title
Changes in faecal bacterial population
Time Frame
Baseline and assessment at 8 weeks for each intervention arm
Title
Ambulatory blood pressure
Description
Blood pressure will be recorded for 30 minutes at baseline and at 8 weeks for each intervention arm
Time Frame
Baseline and assessment at 8 weeks for each intervention arm
Title
Changes in inflammatory, endothelial function and oxidative stress markers
Time Frame
Baseline and assessment at 8 weeks for each intervention arm
Title
Changes in insulin resistance and gut hormones
Time Frame
Baseline and assessment at 8 weeks for each intervention arm
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie A Lovegrove, BSc, PhD, RNutr
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kieran Tuohy, Dr
Organizational Affiliation
FEM-IASMA Research and Innovation centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Food and Nutritional Sciences, University of Reading
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG6 6AP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31840162
Citation
Koutsos A, Riccadonna S, Ulaszewska MM, Franceschi P, Trost 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.
Results Reference
derived

Learn more about this trial

Effect of Apples on cardioVascular Risk And Gut Health

We'll reach out to this number within 24 hrs