We aim to assess the impact of 12-week BG supplementation on blood glucose levels in subjects with impaired fasting glucose levels.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is fasting levels of plasma glucose.
Secondary outcome
-
Background summary
Bitter gourd (BG) (Momordica charantia), is a highly nutritive vegetable from
the cucumber family. It*s fruit (but also other parts of the plant) is widely
consumed around the world and is particularly known for its bitter taste and
distinct warty exterior and an oblong shape. BG is proposed to possess a wide
range of medicinal properties. However, most of these claimed health effects
lack solid scientific evidence, or scientific evidence is based on results of
in vitro or animal models. However, promising potential health effects of BG
are described for its lowering potential of blood glucose. Therefore BG has
great potential to be used as an ingredient or dietary supplement for diabetics
and pre-diabetic patients, in addition to lifestyle advice.
Study objective
We aim to assess the impact of 12-week BG supplementation on blood glucose
levels in subjects with impaired fasting glucose levels.
Study design
The study is a parallel, double blind, controlled trial in which study
participants will receive an intervention for 12 weeks. Research subjects will
come to the research facility for a test day on four occasions, with an
interval of 4 weeks (+/- 1 day for visits 2 and 3).
Intervention
12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference
intervention with 3.6 g/d dried cucumber supplements.
Study burden and risks
There are minor risks for the participants of this study. There are no direct
benefits for the participants. The total amount of blood collected during the
study is within acceptable range (8 to 12 ml per test day), and therefore not
expected to cause any problems. Blood collection may cause some discomfort and
a bruise. Research subjects that will participate in the study will invest
approximately 31 hours during the trial and need to visit the research facility
on 4 occasions. All intervention products (BG and cucumber) are based on
products like available in supermarkets but then freeze dried and powdered. We
will provide a daily dose of 3.6 g dried BG (equivalent to approximately 36 g
fresh BG).
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
Inclusion criteria
• Age 40-75yrs
• BMI >25 kg/m2
• Having a fasting glucose >= 5.6 mmol/L
Exclusion criteria
• Use of medication/supplements that may influence the study results, such as
metformin, gliclazide, glimepiride, tolbutamide, insulin, sitagliptin (DPP4
inhibitor), liraglutide (GLP-1 agonist), acarbose, repaglinide, pioglitazone,
corticosteroids (systemically) , SGLT-2 inhibitors, (judged by our research
physician)
• Having a fasting glucose >11.0 mmol/L
• History of gastro-intestinal surgery or having (serious) gastro-intestinal
complaints
• History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
• Kidney dysfunction (self-reported)
• Reported slimming, medically prescribed or other extreme diets
• Reported weight loss or weight gain of > 5 kg in the month prior to pre-study
screening
• Not willing to give up blood donation during the study
• Current smokers
• Alcohol intake >=14 glasses (women) or >21 glasses (men) of alcoholic
beverages per week, on average
• Not pregnant or lactating
• Abuse of illicit drugs (soft- and hard drugs)
• Food allergies for products that we use in the study
• Participation in another clinical trial at the same time
• Being an employee of the Food, Health & Consumer Research group of Wageningen
Food & Biobased Research or dept. human nutrition and health of Wageningen
University.
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 |
|---|---|
| Other | het traject loopt |
| CCMO | NL79294.091.21 |