Almonds and Health Effects on Metabolism, Vascular Function and Cognition (NCT03419702) | Clinical Trial Compass
CompletedNot Applicable
Almonds and Health Effects on Metabolism, Vascular Function and Cognition
Netherlands43 participantsStarted 2018-01-10
Plain-language summary
The primary objective of the proposed study is to examine and understand the impact of long-term almond consumption on chronic glucose metabolism in subjects with impaired glucose tolerance and/or impaired fasting glucose.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 pulmon…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Insulin sensitivity
Timeframe: Change from control period (week 22 and week 52)