diabetes glucose metabolism
Conditions
Interventions
During the intervention period of 5 months, subjects will receive daily 50 gr
almonds, but not in the 2 months washout and 5 months control periods.
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Aged between 40-75 years - Men and women - BMI between 25-40 kg/m2 (overweight and obese) - Being classified as having prediabetes, either having impaired glucose tolerance (IGT) and/or having impaired fasting glucose (IFG). IGT is defined according the criteria of the WHO and American Diabetes Association (ADA) as two-hour glucose concentrations of 7.8 to 11.0 mmol/l (140 to 199 mg per dL) during the 75-g oral glucose tolerance test. IFG is defined as having a fasting plasma glucose between 6.1 and 7.0 mmol/l (110 to 125 mg per dL) and a two-hour glucose concentration below 7.8 mmol/l (140 mg per dL). - Serum total cholesterol
Exclusion criteria
Exclusion criteria: - Allergy or intolerance to almonds - Serum total cholesterol * 8.0 mmol/L - Serum triacylglycerol * 4.52 mmol/L - Current smoker, or smoking cessation 3 kg in the past three months) - Use medication known to treat blood pressure, lipid or glucose metabolism - Use of an investigational product within another biomedical intervention trial within the previous 1-month - Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis - Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident - Not willing to give up being a blood donor from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study - Not or difficult to venipuncture as evidenced during the screening visit - Use of over-the-counter and prescribed medication or supplements, which may interfere with study measurements to be judged by the principal investigator; - Use of oral antibiotics in 40 days or less prior to the start of the study; - Blood donation in the past 3 months before the start of the study - Not willing to comply to study protocol during study or sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is glucose infusion rate (GIR) determined during a hyperinsulinemic euglycemic clamp, as measure for whole body insulin sensitivity. | — |
Secondary
| Measure | Time frame |
|---|---|
| * To investigate if improved chronic glucose metabolism in subjects with prediabetes after long-term almond consumption translates into improved peripheral and brain vascular function, and enhanced cognitive performance. * To examine to what extent improved chronic glucose metabolism in subjects with prediabetes after long-term almond consumption can be explained by (combined) effects of lowered hepatic lipid accumulation and inflammation, skeletal muscle characteristics, visceral and subcutaneous fat accumulation, pancreatic function or fecal microbiota composition. | — |
Countries
Netherlands
Outcome results
None listed