Glucose Homeostasis and Apple Polyphenols

NCT05951270 | Terminated DMC

• 1 other identifier: NL77812.068.21
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Apple Polyphenols; Prediabetes; Glucose homeostase

Outcome Measures

Primary Outcomes (1)

• Apple polyphenols and glucose homeostasis in prediabetics

  The primary outcome measure is the difference in glucose tolerance before and after the intervention, assessed using the oral glucose tolerance test area under the curve. Participants will undergo three oral glucose tolerance tests during the study: at the beginning, halfway, and the end. Prior to each test, participants will fast for at least 12 hours, consume a normal diet with approximately 150 grams of carbohydrate per day for three days, and avoid strenuous exercise and alcohol for at least 48 hours. During the test, participants will drink a glucose solution and have blood samples taken at various time points (0, 30, 60, 90, and 120 minutes) for analysis of glucose and insulin levels. Fasting insulin and glucose concentrations will be used to calculate insulin sensitivity using the homeostasis model assessment of insulin resistance (HOMA-IR) index. Blood samples will be stored for future use.

  12 weeks

Secondary Outcomes (2)

• Apple polyphenols and circadian pattern of blood glucose levels

  12 weeks

• Apple polyphenols and fecal microbiota composition

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Twelve weeks of 1100 mg of apple polyphenol supplementation. At the start, middle and end of the study, several measurements will take place.

Dietary Supplement: Apple Polyphenols

Control

PLACEBO COMPARATOR

Twelve weeks of 1100 mg of maltodextrin. This product is an enzymatically converted potato starch. The flavor and color will have a similar/identical appearance and taste as all mentioned antioxidants.

Other: Control

Interventions

Apple Polyphenols DIETARY_SUPPLEMENT

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

Also known as: Applephenon

Intervention

Control OTHER

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.

Control

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged from 40 - 70 years
• \< BMI \< 30 kg/m\^2
• Weight-stable for at least 90 days prior to participation (no change in bodyweight, i.e. \< 3kg).
• HbA1c: 5.7% to 6.4%
• Fasting blood glucose levels 100 to 125 mg/dl (5.6 to 6.9 mmol/l)

You may not qualify if:

• Subject following an overly imbalanced or restrictive diet as per nutritional advice
• Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be detrimental for the participants safety or potentially interfering with the study procedures and/or study outcome
• Participants who received antibiotics in the 90 days prior to the start of the study
• Use of laxatives within 14 days prior to the study
• Using medications for gastric or intestinal complaints
• Drug use, interfering with any of the outcome parameters of this study; to be decided by the person who is medically responsible for this study
• Having donated blood in the 3 months prior to the study
• Administration of antioxidant supplements, investigational drugs or participation in any scientific intervention study, which may interfere with this study (to be decided by the principle investigator), in the 14 days prior to the study
• History of side effects towards intake of antioxidant supplements
• Participants who have a gluten or lactose intolerance
• Use of proton pump inhibitors

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Villa Flora

Venlo, Limburg, 5928 SZ, Netherlands

Location

MeSH Terms

Conditions

Prediabetic State; Glucose Intolerance; Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Freddy Troost, Doctor

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: All samples and data will be coded so that no personal information about the participant can be inferred. Each subject will be assigned an individual code that will be visible on the biological samples. The code will include a participant number in chronological order and a test day number in chronological order. In addition, the label of each sample will indicate the date of collection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study conforms to a randomized, double-blinded, placebo-controlled parallel study design.

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 19, 2023
• Study Start: January 14, 2022
• Primary Completion: January 26, 2023
• Study Completion: February 3, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within one year end of study: before 03-02-2024.
• Access Criteria: I have a set of terms of use available to me, which I will use to define the requirements of access to my data collection once the project has ended. * The permitted period of use of the data set * The manner in which the data set can be accessed * Person(s) who is/are authorised to give access to the data collection * The approval of the participants allows for further research using this data set * Conditions related to data security

Locations

NL (1)