Activation of Brain Centers by Short-term Walnut Consumption in Obesity

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity

In brief

The purposes of the study are: * Study Aim 1. To assess the mechanisms underlying the biological effects of short-term walnut consumption on appetite with functional magnetic resonance imaging (fMRI) and assessing neurocognitive function/memory * Study Aim 2. To investigate the effects of walnut consumption (48g per day over 5 days) on appetite and satiety by analyzing molecules which regulate energy homeostasis such as adipokines, as well as resting metabolic rate which measures energy expenditure. * Study Aim 3. To investigate the effects of walnuts (48g per day over 5 days) on insulin resistance, lipids, and inflammatory markers in obesity as well as the effect of walnuts when consumed as part of a mixed meal, on glucose excursions, insulin secretion and the excretion of gut peptides and free fatty acids.

Key facts

Study ID

NCT02673281

Run by

Beth Israel Deaconess Medical Center

People needed

10

Starts

2016-01-01

Expected to finish

2023-03-20

Last updated by the study team

2023-03-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 10 otherwise healthy men or women, 18-65 years old, with a Body Mass Index (BMI) >30kg/m2 or a BMI >27kg/m2 with comorbidities that would require treatment for obesity (assessed through the screening questionnaire and the medical history and physical exam examination during the screening visit).

You may not qualify if…

• Diagnosis of diabetes, defined per American Diabetes Association (ADA) criteria as hemoglobin a1c (Hba1c) > 7.0% and/or fasting glucose > 125 mg/dL and/or random glucose > 200 mg/dL
• Subjects with any medical condition or on any treatment which would interfere with the study outcomes or would make participation potentially harmful such as pregnancy or breastfeeding, anemia, unstable heart disease, stroke, malabsorption syndromes according to a detailed medical history.
• Present alcoholism or drug abuse or use of any medications the dose of which would be changing or plan to initiate any new medications during the study period. These conditions will be screened for by a detailed history and systems review.
• Individuals with nut allergies or allergies to the ingredients of the milkshake (walnuts, mangos, strawberries, bananas, berry medley, pineapple juice, safflower oil, walnut flavoring) are excluded.
• Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neuron or biostimulators, electronic infusion pumps, etc.)
• Subjects with any type of metallic implant that could potentially be displaced or damaged during MRI, such as aneurysm clips, metallic skull plates, surgical implants etc. or metal containing tattoos.
• Anxiety of small spaces and/or claustrophobia
• Subjects with neurological or psychiatric problems which may interfere with or complicate testing (e.g. presence of titubation)
• Body weight above the limitation of the MRI scanning table (330lbs/150 Kg) or body dimensions that could difficult the performance of the scan.
• Subjects who cannot adhere to the experimental protocol for any reason
• Uncontrolled infectious diseases (e.g. human immunodeficiency virus (HIV), hepatitis, chronic infections etc)
• Any uncontrolled endocrine condition, e.g. Cushing's, Acromegaly, etc
• Any cancers or lymphoma
• Eating disorders like anorexia, bulimia
• Weight loss surgery or gastrectomy

Where it is running

• Beth Israel Deaconess Medical Center, Clinical Research Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.