The effects of apple polyphenol supplementation on glucose homeostasis in prediabetic individuals
- Conditions
- impaired glucose toleranceprediabetes10018424
- Registration Number
- NL-OMON52128
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
• Aged from 40 - 70 years
• 22.5 < 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)
• 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
• Abdominal surgery interfering with gastrointestinal function, upon judgement
of the medical doctor, who will decide in-or exclusion based on the surgery
applied
• Participants who received antibiotics in the 90 days prior to the start of
the study
• Use of other medication will be reviewed by a medical doctor, who will decide
on in- or exclusion based on the drug(s) used
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the effect of apple polyphenols supplementation on<br /><br>glucose tolerance. </p><br>
- Secondary Outcome Measures
Name Time Method <p>• To determine whether daily supplementation with an antioxidant cocktail at<br /><br>breakfast and dinner for a period of 12 weeks influences the circadian pattern<br /><br>of blood glucose levels.<br /><br>• To assess the effect of a 12-week period of daily dietary antioxidant<br /><br>supplementation of apple polyphenols on fecal SCFA concentrations and fecal<br /><br>microbiota composition.<br /><br>• To identify whether a combination of amino acids and triglycerides can<br /><br>function as early blood metabolic biomarkers that reflect glucose tolerance<br /><br>status of prediabetic individuals.</p><br>