Diabetes and plant food products

Effect of natural food products on complications in diabetes mellitus type 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN53451803

Enrollment

100

Registered

2012-10-03

Start date

2009-01-01

Completion date

Unknown

Last updated

2017-05-22

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

Conditions

Type 2 diabetes and complications of Type 2 Diabetes mainly cardiovascular disease Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

All participants (diabetics and non-diabetics) receive information about the beneficial effects of a healthy diet with special focus on the importance of fat quality and the role of vegetables in a ba

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Stable metabolic control (constant medication regarding glucose, lipid and uric acid metabolism) 2. Glycated haemoglobin (HbA1c) concentration <9.5% 3. Serum total cholesterol (TC) <300 mg/dl (<7.76 mmol/l) 4. Serum triglycerides (TG) <500 mg/dl (<5.7 mmol/l) 5. Serum creatinine <2.5 mg/dl (<221 µmol/l) 6. Stable body weight, constant dietary habits and physical activity levels for at least four weeks before entry to the study

Exclusion criteria

Exclusion criteria: 1. Change of dietary habits 2. Frequency of physical activity or body weight within the study period 3. Smoking 4. Intake of fish oil capsules and other fatty acid supplements 5. Change of medication

Design outcomes

Primary

Measure	Time frame
1. DNA damage (single and double strand breaks): Comet assay in peripheral blood mononucleated cells (PBMCs), performed at baseline, after 4, 8 (end of intervention) and 16 weeks 2. Chromosomal damage: Cytokinesis-block micronucleus assay in PBMCs and buccal cells, performed at baseline and after 8 weeks	—

Secondary

Measure	Time frame
1. Lipid metabolism: total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides (enzymatically, Aeroset, Abbott Diagnostics), LDL-subfractions (Lipoprint LDL system) performed at baseline, after 4, 8 (end of intervention) and 16 weeks, except for LDL subfractions, which were measured at baseline and after 4 and 8 weeks 2. Glucose metabolism: fasting plasma glucose (enzymatically by the hexokinase method; Aeroset, Abbott Diagnostics), glycosylated haemoglobin (automated Glycohemoglobin Analyzer), performed at baseline, after 4, 8 (end of intervention) and 16 weeks 3. Inflammation: IL-6 (Elisa), C-reactive protein (CRP) (hs-Elisa), performed at baseline, after 4 and 8 weeks 4. Metabolomics: LCMS-based analysis, performed at baseline and after 8 weeks	—

Measure

Time frame

1. Lipid metabolism: total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides (enzymatically, Aeroset, Abbott Diagnostics), LDL-subfractions (Lipoprint LDL system) performed at baseline, after 4, 8 (end of intervention) and 16 weeks, except for LDL subfractions, which were measured at baseline and after 4 and 8 weeks 2. Glucose metabolism: fasting plasma glucose (enzymatically by the hexokinase method; Aeroset, Abbott Diagnostics), glycosylated haemoglobin (automated Glycohemoglobin Analyzer), performed at baseline, after 4, 8 (end of intervention) and 16 weeks 3. Inflammation: IL-6 (Elisa), C-reactive protein (CRP) (hs-Elisa), performed at baseline, after 4 and 8 weeks 4. Metabolomics: LCMS-based analysis, performed at baseline and after 8 weeks

—

Countries

Austria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026