We aim to assess the impact of 4-week BG supplementation on blood glucose levels and glucose tolerance in subjects with an impaired fasting glucose or with an impaired glucose tolerance. In addition we will evaluate how BG supplements modulate…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
fasting levels of plasma glucose and 2hour plasma glucose after a 75-gram OGTT.
Secondary outcome
HbA1c, fructosamine, insulin (fasting and in response to a 75-OGTT). From the
fasting glucose and insulin values we will calculate HOMA-IR score. We will
also measure glucose responses during a three day controlled dietary period.
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 it 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.
Study objective
We aim to assess the impact of 4-week BG supplementation on blood glucose
levels and glucose tolerance in subjects with an impaired fasting glucose or
with an impaired glucose tolerance. In addition we will evaluate how BG
supplements modulate glucose response curves during meal intake. We will do
this in a dietary controlled setting and via continues blood glucose
measurements.
Study design
The study is a randomised, cross-over, double blind, controlled trial in which
study participants will receive two 4-week interventions with a washout period
of 4 weeks between interventions. Study subjects will visit our research
facility before and after each intervention period for a test day. In the third
intervention week we will provide a 3-day controlled diet and we will monitor
glucose responses via a continuous glucose monitoring device.
Intervention
4-week intervention with 2.4g/d dried bitter-gourd supplements and a reference
intervention with 2.4g/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 the accaptable range and therefore not expected to cause any
problems. Blood collection via a catheter may cause some discomfort and a
bruise. Study subjects that will participate in the study will invest
approximately 31 hours during the trial and need to visit the research facility
on 14 occasions. All intervention products (BG and cucumber) are available in
supermarkets. We will provide a daily dose of 2.4g dried BG (equivalent to
approximately 100g fresh BG).
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
age 50-75yrs
BMI >25 kg/m2
Having veins suitable for blood sampling via a catheter (judged by study
nurse/medical doctor)
Having one or more of the following criteria:
o HbA1c >5.7%
o fasting glucose >5.6mmol/L
o two-hour glucose levels >7.8 mmol/L on the 75-g oral glucose tolerance test .
Exclusion criteria
* History of gastro-intestinal surgery or having (serious) gastro-intestinal
complaints
* History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
* Kidney dysfunction (self-reported)
* Use of medication/supplements that may influence the study results, such as
medicines known to interfere with glucose homeostasis (judged by medical doctor)
* Anaemia (Hb values <7.5 for women and <8.5 for men)
* 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 *4 glasses of alcoholic beverages per day
* Abuse of illicit 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
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | het traject loopt |
| CCMO | NL70259.081.19 |