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Mixed Nuts and Brain Vascular Function

Study Purpose

Impaired brain vascular function precedes the development of reduced cognitive performance, while brain insulin-resistance is also associated with cognitive decline. The Mediterranean diet, which is rich in nuts, may protect against the development of impaired cognitive performance. The hypothesis is that long-term mixed nut consumption increases brain insulin-sensitivity thereby improving brain vascular function and cognitive performance. The primary objective is to evaluate in elderly men and women the effect of 16-week mixed nut consumption on cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labelling (ASL). Cerebral blood flow is a robust and sensitive physiological marker of brain vascular function. Secondary objectives are to investigate effects on the cerebral blood flow response to intranasal insulin delivery

  • - a marker of insulin-sensitivity in the human brain - as quantified by ASL, and cognitive functioning as assessed with a neuropsychological test battery.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 60 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Aged between 60-70 years.
  • - BMI between 25-35 kg/m2.
  • - Fasting plasma glucose < 7.0 mmol/L.
  • - Fasting serum total cholesterol < 8.0 mmol/L.
  • - Fasting serum triacylglycerol < 4.5 mmol/L.
  • - Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg.
  • - Stable body weight (weight gain or loss < 3 kg in the past three months) - 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.

Exclusion Criteria:

  • - Allergy or intolerance to nuts.
  • - Left-handedness.
  • - Current smoker, or smoking cessation < 12 months.
  • - Diabetic patients.
  • - Familial hypercholesterolemia.
  • - Abuse of drugs.
  • - More than 3 alcoholic consumptions per day.
  • - Use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators.
  • - Use medication 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.
- Contra-indications for MRI imaging (e.g. pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04210869
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Maastricht University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Peter J Joris, PhD
Principal Investigator Affiliation Maastricht University Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Vascular Function, Cerebral Blood Flow
Arms & Interventions

Arms

Experimental: Experimental

Mixed nuts

No Intervention: Control

No mixed nuts

Interventions

Dietary Supplement: - Mixed Nuts

Study volunteers will receive daily 60 g of mixed nuts (15 g walnut, 15 g cashew, 15 g hazelnut, 15 g pistachio) for 16 weeks.

Contact a Trial Team

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International Sites

Maastricht University Medical Center, Maastricht, Limburg, Netherlands

Status

Recruiting

Address

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER

Site Contact

Peter J Joris, PhD

p.joris@maastrichtuniversity.nl

0031433881311

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