Glucose Homeostasis and Apple Polyphenols

NCT05951270 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-07-19

No results posted yet for this study

Summary

The primary objective is to investigate the effect of apple polyphenol supplementation for 12 weeks on glucose homeostasis in prediabetic individuals. Further, this study has three secondary objectives: 1) to investigate whether daily supplementation at breakfast and dinner with apple polyphenols for 12 weeks affects the rhythm of glucose uptake over the day and reduces fasting glucose levels and postprandial glucose peaks; 2) to determine the effect of daily supplementation with apple polyphenols for 12 weeks on biomarkers of metabolic health; 3) to assess whether daily supplementation with apple polyphenols for 12 weeks alters fecal SCFA concentrations and fecal microbiota composition.

Conditions

  • PreDiabetes
  • Impaired Glucose Tolerance
  • Glucose Metabolism Disorders

Interventions

DIETARY_SUPPLEMENT

Apple Polyphenols

ApplePhenon® is prepared from unripe green apples (malus domestica) and contains a large amounts of polyphenols. The supplement contains 63.8% procyanidins, 12.4% flavon-3-ols, 6.5% chalcones and 10.8% phenolcarboxylic acids

OTHER

Control

The placebo used in this study is 1100 mg maltodextrin (Avebe, Veendam, the Netherlands). This product is an enzymatically converted potato starch. The flavor and color will have a similar/identical appearance and taste as all mentioned antioxidants.

Sponsors & Collaborators

  • Maastricht University

    lead OTHER

Principal Investigators

  • Freddy Troost, Doctor · Maastricht University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2023-01-26
Completion
2023-02-03

Countries

  • Netherlands

Study Locations

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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 NCT05951270 on ClinicalTrials.gov