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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017537

Enrollment

Registered

2019-08-05

Start date

2020-01-09

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The effect of calanus oil on glucose tolerance and insulin resistance in prediabetic patients is investigated

Interventions

Group 1: Calanus Group: daily intake of Calanus capsules for a period of 16 weeks. There are 30 subjects per study arm. Group 2: Placebo group: daily intake of placebo capsules for a period of 16 week

Eligibility

Sex/Gender

All

Age

40 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Glucose levels after oral glucose tolerance test (75-g OGTT): area under the curve and 2-hour value	—

Secondary

Measure	Time frame
o Insulin levels after oral glucose tolerance test (75-g OGTT): area under the curve and 2-hour value o HbA1c o Fasting glucose o Fasting insulin o C-Peptide o Inflammatory parameters (hsCRP, TNFa, IL-1-ß, IL-6, MCP-1) o Immune risk profile (CD4, CD8, CD3, CD45RA, CCR7, CD27, CD28 in peripheral T-cells) o Adiponectin, leptin o Sirtuins (SIRT 1, 3 and 5) o TG, LDL, HDL, Total cholesterol o Oxidative Stress marker (MDA, ADMA) o Omega-3 Index o Blood count o Blood pressure o Safety parameters (creatinine, GOT, GPT) o Dietary habits: Food frequency questionnaire at screening, 3-day food record o Freiburg questionnaire on physical activity o Anthropometric measures: weight, height, BMI, Bioelectrical impedance analysis o Arterial stiffness via carotid-femoral pulse wave velocity (PWV) o Sociodemographic parameters: Age, sex, school qualification, profession, marital status o Other parameters: smoking, medication and supplement intake, quality of life (SF 36)	—

Measure

Time frame

o Insulin levels after oral glucose tolerance test (75-g OGTT): area under the curve and 2-hour value o HbA1c o Fasting glucose o Fasting insulin o C-Peptide o Inflammatory parameters (hsCRP, TNFa, IL-1-ß, IL-6, MCP-1) o Immune risk profile (CD4, CD8, CD3, CD45RA, CCR7, CD27, CD28 in peripheral T-cells) o Adiponectin, leptin o Sirtuins (SIRT 1, 3 and 5) o TG, LDL, HDL, Total cholesterol o Oxidative Stress marker (MDA, ADMA) o Omega-3 Index o Blood count o Blood pressure o Safety parameters (creatinine, GOT, GPT) o Dietary habits: Food frequency questionnaire at screening, 3-day food record o Freiburg questionnaire on physical activity o Anthropometric measures: weight, height, BMI, Bioelectrical impedance analysis o Arterial stiffness via carotid-femoral pulse wave velocity (PWV) o Sociodemographic parameters: Age, sex, school qualification, profession, marital status o Other parameters: smoking, medication and supplement intake, quality of life (SF 36)

—

Countries

Germany

Contacts

Public ContactMilena Burhop

Institut für Lebensmittelwissenschaft und Humanernährung

burhop@nutrition.uni-hannover.de0511 762 14556

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026