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…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the effect of apple polyphenols supplementation on
glucose tolerance.
Secondary outcome
• To determine whether daily supplementation with an antioxidant cocktail at
breakfast and dinner for a period of 12 weeks influences the circadian pattern
of blood glucose levels.
• To assess the effect of a 12-week period of daily dietary antioxidant
supplementation of apple polyphenols on fecal SCFA concentrations and fecal
microbiota composition.
• To identify whether a combination of amino acids and triglycerides can
function as early blood metabolic biomarkers that reflect glucose tolerance
status of prediabetic individuals.
Background summary
Diet can influence the development and progression of type 2 diabetes. It has
been shown that a combination of polyphenols could contribute to increased
glucose tolerance. Polyphenols may enhance insulin signaling, beta
cell-mediated insulin secretion and decrease glucose absorption rate in the
intestine by decreasing oxidative stress. Furthermore, antioxidants affect the
composition of the intestinal microbiota, which in turn changes the production
of microbial fermentation derived metabolites, such as short chain fatty acids
(SCFA). SCFA can also enhance insulin signaling. Finally, nutrients can have
robust effects on the circadian system especially for clocks in peripheral
tissues. For example high-fat diets blunt feeding/fasting cycles that also
leads to increased blood fatty acid and glucose levels that subsequently
contribute to the development of impaired glucose tolerance. In contrast,
dietary polyphenols can regulated the circadian clock gene expression
preventing circadian disruption. In order to increase glucose tolerance the
effects of a 12-week supplementation with apple polyphenols will be
investigated. It is hypothesized that apple polyphenols can increase the
glucose tolerance in prediabetic individuals.
Study objective
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.
Study design
The study conforms to a randomized, double-blinded, placebo-controlled parallel
study design.
Intervention
Twelve weeks of 1100 mg of apple polyphenol supplementation. At the start,
middle and end of the study, several measurements will take place.
Study burden and risks
There are small burdens volunteers can experience during this study. After the
screening visit, participants will have to visit the Maastricht University
research laboratory at Villa Flora, Venlo on three occasions. In total, a
participant will spend approximately 11 hours at the university facility. They
will have to take antioxidant supplementation twice daily for a time period of
twelve weeks; the supplements used have been proven to be safe for human use.
During two visits spread over 12 weeks, a total of 54 mL blood will be sampled
by venipuncture via an evacuated tube system, which may lead to minor
discomfort and/or a small hematoma at the site of puncture. During two of these
visits an oral glucose tolerance test will be performed. Similar discomfort as
during the venipuncture may be expected. Subjects collect faecalfecal samples
at home. Moreover, questionnaires will have to be filled out at several
occasions during this study. Except general information about their health
status during the screening visit, subjects may not perceive direct benefits as
a result of participating in this trial, since effects may be small and of
temporary nature. An indirect effect of this study will be the insights
gathered about the effectiveness of the study product, and this may contribute
to development of new food products for healthy and/or sick people.
Villafloraweg 1
Venlo 5928 SZ
NL
Villafloraweg 1
Venlo 5928 SZ
NL
Listed location countries
Age
Inclusion criteria
• 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)
Exclusion criteria
• 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77812.068.21 |