Effects of almond consumption on chronic glucose regulation, vascular function and cognitive performance: The AL-INCLUSIVE trial

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 84

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 < 8.0 mmol/L (further testing is recommended for
excessive hyperlipidemia [serum total cholesterol * 8.0 mmol/L] according to
the Standard for cardiovascular 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
trial within 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
cardiovascular event, 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 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 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is glucose infusion rate (GIR) determined during a<br /><br>hyperinsulinemic euglycemic clamp, as measure for whole body insulin<br /><br>sensitivity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* To investigate if improved chronic glucose metabolism in subjects with<br /><br>prediabetes after long-term almond consumption translates into improved<br /><br>peripheral and brain vascular function, and enhanced cognitive performance.<br /><br><br /><br>* To examine to what extent improved chronic glucose metabolism in subjects<br /><br>with prediabetes after long-term almond consumption can be explained by<br /><br>(combined) effects of lowered hepatic lipid accumulation and inflammation,<br /><br>skeletal muscle characteristics, visceral and subcutaneous fat accumulation,<br /><br>pancreatic function or fecal microbiota composition.</p><br>