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Effect of Calanus® Oil on glucose tolerance and insulin resistance in prediabetics – proof-of-principle

Not Applicable
Recruiting
Conditions
The effect of calanus oil on glucose tolerance and insulin resistance in prediabetic patients is investigated
Registration Number
DRKS00017537
Lead Sponsor
Institut für Lebensmittelwissenschaft und Humanernährung
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

o Age: 40-75 years
o Willingness to take part on the whole study procedure
o Willingness to take the capsules over 16 weeks
o Stable weight since at least half a year (±3 kg)
o ADA Prediabetes Screening Test Score > 5
o Glucose levels 2 hours after 75-g OGTT >140-199 mg/dl
o Omnivorous diet

Exclusion Criteria

o Severe chronic diseases (i.e., diagnosed diabetes, cardiovascular disease, liver disease, renal insufficiency, cancer)
o Chronic diseases involving the immune system (i.e., Crohn’s disease, colitis ulcerosa, rheumatoid arthritis, multiple sclerosis)
o Use of any medication and food ingredients affecting blood glucose control and insulin sensitivity (including isolated dietary fiber such as guar gum, pectins, psyllium)
o consumption of n3 fatty acid supplements
o Permanent use of immunosuppressive drugs (corticoids etc.)
o Abuse of alcohol and drugs
o Participation in another clinical study within the last 30 days
o Pregnancy
o Hypertonia: > 160 mmHg systolic blood pressure and > 100 mmHg diastolic blood pressure
o Planned operation in the next 3 months

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Glucose levels after oral glucose tolerance test (75-g OGTT): area under the curve and 2-hour value
Secondary Outcome Measures
NameTimeMethod
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