Last updated: March 3, 2022
Sponsor: Maastricht University Medical Center
Overall Status: Completed
Phase
N/A
Condition
Diabetes Mellitus, Type 2
Diabetes And Hypertension
Diabetes (Pediatric)
Treatment
N/AClinical Study ID
NCT03419702
METC173015
Ages 40-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged between 40-70 years
- Men and women
- BMI between 25-35 kg/m2 (overweight and obese)
- Being classified as having impaired glucose tolerance (IGT) and/or impaired fastingglucose (IFG). IGT is defined according the criteria of the WHO and American DiabetesAssociation (ADA) as two-hour glucose concentrations of 7.8 to 11.0 mmol/l (140 to 199mg per dL) during the 75-g oral glucose tolerance test. IFG is defined as having afasting plasma glucose between 6.1 and 7.0 mmol/l (110 to 125 mg per dL) and atwo-hour glucose concentration below 7.8 mmol/l (140 mg per dL).
- Serum total cholesterol < 8.0 mmol/L (further testing is recommended for excessivehyperlipidemia [serum total cholesterol ≥ 8.0 mmol/L] according to the Standard forcardiovascular risk management of the Dutch general practitioners community [NHG])
- Serum triacylglycerol < 4.52 mmol/L
- No current smoker
- No diabetic patients
- No familial hypercholesterolemia
- No abuse of drugs
- Not more than 4 alcoholic consumption per day with a maximum of 21 per week
- Stable body weight (weight gain or loss < 3 kg in the past three months)
- No use of medication known to treat blood pressure, lipid or glucose metabolism
- No use of an investigational product within another biomedical intervention trialwithin the previous 1-month
- No 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
- No active cardiovascular disease like congestive heart failure or cardiovascularevent, such as an acute myocardial infarction or cerebrovascular accident
- Willingness to give up being a blood donor from 8 weeks before the start of the study,during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
- Willing to comply to study protocol during study
- Informed consent signed
Exclusion
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 <12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 4 alcoholic consumptions per day or 21 per week
- Unstable body weight (weight gain or loss > 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 withinthe 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 interferewith 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
Study Design
Total Participants: 43
Study Start date:
January 10, 2018
Estimated Completion Date:
December 03, 2021
Study Description
Connect with a study center
Maastricht University, Department of Nutrition and Movement Sciences
Maastricht, Limburg 6200 MD
NetherlandsSite Not Available

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