Effect of Apples on cardioVascular Risk And Gut Health

NCT01988389 | Completed DMC

• 2 other identifiers: 13/22University of Reading
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Changes in blood lipid levels

  Baseline and assessment at 8 weeks for each intervention arm including a 4 week wash out period.

Secondary Outcomes (7)

• Evaluation of endothelial function by using laser doppler iontophoresis (LDI)

  Baseline and assessment at 8 weeks for each intervention arm.

• Changes in vascular stiffness by pulse wave analysis (PWA)

  Baseline and assessment at 8 weeks for each intervention arm

• Changes in faecal bacterial population

  Baseline and assessment at 8 weeks for each intervention arm

• Ambulatory blood pressure

  Baseline and assessment at 8 weeks for each intervention arm

• Changes in inflammatory, endothelial function and oxidative stress markers

  Baseline and assessment at 8 weeks for each intervention arm

Study Arms (2)

whole apples

EXPERIMENTAL

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

OTHER

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)

Interventions

whole apples (WA) DIETARY_SUPPLEMENT

whole apples

apple juice (AJ) DIETARY_SUPPLEMENT

apple juice squash

Eligibility Criteria

• Age: 23 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mildly hypercholesterolemic: TC\>5.2 and \<7.9 mmol/L
• BMI: 20-35
• Age: 23-69
• Normal liver and kidney function

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Reading: lead
• Fondazione Edmund Mach di San Michele all'Adige: collaborator

Study Sites (1)

Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31840162 DERIVED

Study Officials

• Julie A Lovegrove, BSc, PhD, RNutr

  University of Reading

  PRINCIPAL INVESTIGATOR

• Kieran Tuohy, Dr

  FEM-IASMA Research and Innovation centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: November 20, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

GB (1)