Effects of Peanut Consumption on Brain Function

NCT05724654 | Completed

• 1 other identifier: METC 22-046
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Impaired brain vascular function precedes the development of reduced cognitive performance, while brain insulin-resistance is also associated with cognitive decline. Peanut consumption has already been shown to beneficially affect cognitive performance. However, underlying mechanisms have not yet been established, while well-controlled trials on longer-term effects of peanuts on cognitive performance are highly needed. The hypothesis is that longer-term peanut consumption has beneficial effects on (regional) cerebral blood flow responses (primary outcome), which may relate to an improved cognitive performance (secondary outcome) in older men and women. Important objectives are to investigate in older adults the effect of 16-week peanut consumption on (i) brain vascular function in cognitive-control brain areas, and (ii) brain insulin-sensitivity. We will also focus on changes in cognitive performance as assessed with a neuropsychological test battery (secondary objective). Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin (brain insulin-sensitivity) will be quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labeling (ASL).

Conditions

Brain Vascular Function; Cerebral Blood Flow; Brain Insulin Sensitivity; Cognitive Performance

Outcome Measures

Primary Outcomes (2)

• Brain Vascular Function

  Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)

  Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.

• Brain Insulin Sensitivity

  Change in cerebral blood flow, as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL), before and after application of intranasal insulin (160 IU)

  Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.

Secondary Outcomes (1)

• Cognitive Performance

  Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.

Other Outcomes (30)

• Brain Perfusion

  Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.

• Retinal Microvasculature

  Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.

• Systolic Blood Pressure

  Change in outcomes at the end of a 16-week skin roasted peanut intervention and 16-week control period.

Study Arms (2)

Experimental

EXPERIMENTAL

Skin roasted peanuts

Dietary Supplement: Skin roasted peanuts

Control

NO INTERVENTION

No skin roasted peanuts

Interventions

Skin roasted peanuts DIETARY_SUPPLEMENT

Study volunteers will receive daily 60 g of skin roasted peanuts for 16 weeks.

Experimental

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, aged between 60-75 years
• BMI between 20-35 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

You may not qualify if:

• Allergy or intolerance to peanuts
• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• The Peanut Institute Foundation (TPIF): collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Location

Related Publications (1)

• Kerkhof L, Mensink RP, Plat J, Nijssen KMR, Joris PJ. Longer-term skin-roasted peanut consumption improves brain vascular function and memory: A randomized, single-blind, controlled crossover trial in healthy older adults. Clin Nutr. 2025 Dec;55:170-179. doi: 10.1016/j.clnu.2025.10.020. Epub 2025 Nov 1.

  PMID: 41205298 DERIVED

Study Officials

• Peter J Joris, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study participants will receive in random order daily 60 g of skin roasted peanuts (peanut intervention) or no peanuts for a total of 16 weeks (control intervention), separated by a wash-out period of at least 8 weeks.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 13, 2023
• Study Start: February 2, 2023
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

NL (1)