Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673281
Recruitment Status : Active, not recruiting
First Posted : February 3, 2016
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Obesity Other: Walnut shake Other: Placebo shake Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Activation of Brain Centers Responsible for Decreasing Appetite and Improvement of the Cardiometabolic Profile by Short-term Walnut Consumption in Obesity: A Pilot Study
Study Start Date : January 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: Walnut shake
All subjects will have 2 5-day visits to the BIDMC clinical research center, one where they will receive active milkshake containing 48g of walnuts daily in a single morning meal instead of breakfast, and another where they will receive a "placebo" milkshake without nuts
Other: Walnut shake
walnut shake will be administered for 5 days as a morning snack instead of a typical breakfast

Placebo Comparator: Placebo shake
All subjects will have 2 5-day visits to the BIDMC clinical research center, one where they will receive active milkshake containing 48g of walnuts daily in a single morning meal instead of breakfast, and another where they will receive a "placebo" milkshake without nuts
Other: Placebo shake
placebo shake will be administered for 5 days as a morning snack instead of a typical breakfast




Primary Outcome Measures :
  1. brain centers activation related to food intake assessed using functional magnetic resonance imaging (fMRI) [ Time Frame: fasting Day 5 ]
    The investigators will use functional magnetic resonance imaging (fMRI) to identify brain centers activation related to food intake after the consumption of the walnut shake compared to the placebo shake.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673281


Locations
Layout table for location information
United States, Massachusetts
Beth Israel Deaconess Medical Center, Clinical Research Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Christos S Mantzoros, MD Beth Israel Deaconess Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Christos Mantzoros, MD DSc h.c. PhD mult, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02673281    
Other Study ID Numbers: 2015P000343
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant data will be kept confidential.
Keywords provided by Christos Mantzoros, Beth Israel Deaconess Medical Center:
walnuts
brain
appetite
energy intake
obesity
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms