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A Study Examining Effects of Apples/ Apple Products on Heart Disease Risk

NCT01585519 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-04-03

No results posted yet for this study

Summary

This study will examine if health benefits of consuming nutrient-rich apples, an apple extract and freeze dried apple product will be similar. 50 volunteers at increased risk of heart disease will consume either a low apple diet (\<1 portion/d), 2 high or low polyphenol apples/day, an apple extract, or freeze dried apple granule product for 4 weeks (ten participants per group, randomly assigned). Apart from the extract group, all volunteers will consume a placebo. All volunteers will follow a low apple diet (\<1 apple per day) other than what has been provided by the research team. Volunteers will complete food diaries at the start and end of the study and a number of questionnaires. Blood and urine samples collected at 0 and 4 weeks

Conditions

Interventions

DIETARY_SUPPLEMENT

High/ Low Epicatechin Apples/ Apple Extract/ Granules

(Group 1) Low Apple Diet (i.e. \<1 portion per day) + 2 placebo capsules daily. (Group 2) 2 x High Epicatechin Apples daily + 2 placebo capsules daily. (Group 3) 2 x Low Epicatechin Apples daily + 2 placebo capsules daily. (Group 4) Low apple diet + 2 x 4.4g of apple granules daily + 2 placebo capsules daily. (Group 5) Low apple diet + 2 x Apple Extract Capsules daily.

Sponsors & Collaborators

  • Queen's University, Belfast

    lead OTHER

Principal Investigators

  • Jayne V Woodside, PhD · Queen's University, Belfast

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-10-31
Completion
2017-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01585519 on ClinicalTrials.gov