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

NCT02673281 | Completed

• 1 other identifier: 2015P000343
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

walnuts; brain; appetite; energy intake; obesity

Outcome Measures

Primary Outcomes (1)

• brain centers activation related to food intake assessed using functional magnetic resonance imaging (fMRI)

  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.

  fasting Day 5

Study Arms (2)

Walnut shake

EXPERIMENTAL

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

Placebo shake

PLACEBO COMPARATOR

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

Interventions

Walnut shake OTHER

walnut shake will be administered for 5 days as a morning snack instead of a typical breakfast

Walnut shake

Placebo shake OTHER

placebo shake will be administered for 5 days as a morning snack instead of a typical breakfast

Placebo shake

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center, Clinical Research Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• Tuccinardi D, Perakakis N, Farr OM, Upadhyay J, Mantzoros CS. Branched-Chain Amino Acids in relation to food preferences and insulin resistance in obese subjects consuming walnuts: A cross-over, randomized, double-blind, placebo-controlled inpatient physiology study. Clin Nutr. 2021 May;40(5):3032-3036. doi: 10.1016/j.clnu.2021.01.020. Epub 2021 Jan 23.

  PMID: 33541836 DERIVED

• Farr OM, Tuccinardi D, Upadhyay J, Oussaada SM, Mantzoros CS. Walnut consumption increases activation of the insula to highly desirable food cues: A randomized, double-blind, placebo-controlled, cross-over fMRI study. Diabetes Obes Metab. 2018 Jan;20(1):173-177. doi: 10.1111/dom.13060. Epub 2017 Aug 17.

  PMID: 28715141 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christos S Mantzoros, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD DSc h.c. PhD mult

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: February 3, 2016
• Study Start: January 1, 2016
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)