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OpenTrials
Completed

NCT Number: NCT01988389

Effect of Apples on cardioVascular Risk And Gut Health

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.

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Key information

Conditions

Mild Hypercholesterolemia

Age range

23 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

whole apples (WA)

Dietary Supplement

apple juice (AJ)

Dietary Supplement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Fondazione Edmund Mach di San Michele all'Adige

Registry information

Official study title

Effect of Apples Consumption on Blood Lipid Levels,Vascular Function and Gut Health in Moderate Hypercholesterolemic Subjects

Acronym: AVAG

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 20, 2013
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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