ObesityNCT02673281
Activation of Brain Centers by Short-term Walnut Consumption in Obesity
A study testing Walnut shake in people with Obesity, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Walnut shake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 20 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center, Clinical Research Center
Boston, Massachusetts, 02215
About this study
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
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.
Read the detailed description
Study Overview:
The study is a short-term, pilot, double-blinded, randomized, cross-over inpatient study testing the effects of either 48 g of walnuts per day vs. an ad libitum diet without walnuts on appetite and satiety, insulin resistance, basal metabolic rate, lipids, adipokines, heart rate, vascular reactivity, and markers of inflammation. The investigators propose that subjects stay in the controlled environment of our Clinical Research Center (CRC) for the entire duration of each arm of the study (5 days), which will be separated from the other arm by a one month long wash out period. Walnuts/placebo administration will be in the form of a milkshake with identical macronutrient content. Each study subject will be fed an identical diet during both admissions to minimize variability.
Study Design:
Screening: Potential subjects will be initially screened through telephone to determine that they are eligible for inclusion in the study according to the inclusion/exclusion criteria. If they pass the phone screening then they will be asked to come at CRC for a screening visit. They will have a detailed medical history, physical exam, fasting lab tests such as fructosamine, international normalized ratio (INR), prothrombin time (PT), complete blood count (CBC), metabolic panel including glucose and lipid profile, electrocardiogram (EKG), vitals, anthropometry and pregnancy test for women and if eligible for participation they will sign the informed consent of the study.
Subjects meeting eligibility criteria will be randomized to start with either the active intervention or placebo. Subjects will complete a 3-day food diary prior to visit 1 to document baseline diet. They will also meet the dietitian who will advise them on following a prudent diet and maintaining a stable exercise pattern for 2 weeks before the first visit and between both visits. Subjects will also be advised to avoid walnuts during this period. Subjects will also be required to maintain their weight +/- 3kg between screening and between study visits.
In-patient CRC Admission: In order to ensure stable study conditions, eligible subjects will be asked to stay in the CRC of the Beth Israel Deaconess Medical Center (BIDMC) for a period of 5 days on each of the study visits. They will receive advice on isocaloric diet but will be allowed to eat ad libitum and will be randomized prior to the first visit regarding the sequence of the study visits. All subjects will have 2 5-day visits to the CRC, one where they receive active milkshake containing 48g of walnuts daily in a single morning meal instead of breakfast, and another where they receive a "placebo" milkshake without nuts. Subjects will have their hunger assessed using visual analog scales before breakfast, lunch and dinner each day. These inpatient visits will be separated from each other by a 1-month washout period. Subjects and investigators will be blinded regarding the study sequence.
For each of the inpatient series, subjects will be admitted to CRC the night before the first day of the study. On day 1, subjects will have baseline measures such as vitals, anthropometry, brief medical history, physical exam, pregnancy test for women. Prior to leaving the CRC on day 5, subjects will again have vitals, blood draws for several markers including fructosamine, lipid panel, high sensitivity c-reactive protein (hsCRP), adiponectin and leptin, resting metabolic rate (RMR), anthropometry and body composition measures. On this last day, they will also undergo neurocognitive testing and an fMRI at the fasting state while viewing food cues and a mixed meal challenge either with or without walnuts. Subjects will be discharged from the CRC after their final testing and after evaluating the milkshake they were consuming on day 5 and will resume their normal diet for a period of 4 weeks after which time they will return to the CRC for a further 5 days for the second study visit. Prior Visit 2 participants will complete another 3-day food diary. If they received placebo milkshake on the first visit, they will have the walnut milkshake on the second visit and vice-versa.
- Conditions
- Obesity
- Being tested
- Walnut shake, Placebo shake
- Keywords
- walnuts, brain, appetite, energy intake, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walnut shakeOther
walnut shake will be administered for 5 days as a morning snack instead of a typical breakfast
Placebo shakeOther
placebo shake will be administered for 5 days as a morning snack instead of a typical breakfast
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: fasting Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJan 2016
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christos Mantzoros, Beth Israel Deaconess Medical Center
- Investigators
- Christos S Mantzoros, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673281
- Sponsor's protocol ID
- 2015P000343
- Status last verified
- Mar 2023
- First submitted
- 13 Jan 2016
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual Participant data will be kept confidential.
Publications
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.
PubMed 33541836Farr 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.
PubMed 28715141
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02673281
- Acronym / sponsor ID
- 2015P000343
- Conditions
- Obesity
- Keywords
- walnuts, brain, appetite, energy intake, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Overview:
The study is a short-term, pilot, double-blinded, randomized, cross-over inpatient study testing the effects of either 48 g of walnuts per day vs. an ad libitum diet without walnuts on appetite and satiety, insulin resistance, basal metabolic rate, lipids, adipokines, heart rate, vascular reactivity, and markers of inflammation. The investigators propose that subjects stay in the controlled environment of our Clinical Research Center (CRC) for the entire duration of each arm of the study (5 days), which will be separated from the other arm by a one month long wash out period. Walnuts/placebo administration will be in the form of a milkshake with identical macronutrient content. Each study subject will be fed an identical diet during both admissions to minimize variability.
Study Design:
Screening: Potential subjects will be initially screened through telephone to determine that they are eligible for inclusion in the study according to the inclusion/exclusion criteria. If they pass the phone screening then they will be asked to come at CRC for a screening visit. They will have a detailed medical history, physical exam, fasting lab tests such as fructosamine, international normalized ratio (INR), prothrombin time (PT), complete blood count (CBC), metabolic panel including glucose and lipid profile, electrocardiogram (EKG), vitals, anthropometry and pregnancy test for women and if eligible for participation they will sign the informed consent of the study.
Subjects meeting eligibility criteria will be randomized to start with either the active intervention or placebo. Subjects will complete a 3-day food diary prior to visit 1 to document baseline diet. They will also meet the dietitian who will advise them on following a prudent diet and maintaining a stable exercise pattern for 2 weeks before the first visit and between both visits. Subjects will also be advised to avoid walnuts during this period. Subjects will also be required to maintain their weight +/- 3kg between screening and between study visits.
In-patient CRC Admission: In order to ensure stable study conditions, eligible subjects will be asked to stay in the CRC of the Beth Israel Deaconess Medical Center (BIDMC) for a period of 5 days on each of the study visits. They will receive advice on isocaloric diet but will be allowed to eat ad libitum and will be randomized prior to the first visit regarding the sequence of the study visits. All subjects will have 2 5-day visits to the CRC, one where they receive active milkshake containing 48g of walnuts daily in a single morning meal instead of breakfast, and another where they receive a "placebo" milkshake without nuts. Subjects will have their hunger assessed using visual analog scales before breakfast, lunch and dinner each day. These inpatient visits will be separated from each other by a 1-month washout period. Subjects and investigators will be blinded regarding the study sequence.
For each of the inpatient series, subjects will be admitted to CRC the night before the first day of the study. On day 1, subjects will have baseline measures such as vitals, anthropometry, brief medical history, physical exam, pregnancy test for women. Prior to leaving the CRC on day 5, subjects will again have vitals, blood draws for several markers including fructosamine, lipid panel, high sensitivity c-reactive protein (hsCRP), adiponectin and leptin, resting metabolic rate (RMR), anthropometry and body composition measures. On this last day, they will also undergo neurocognitive testing and an fMRI at the fasting state while viewing food cues and a mixed meal challenge either with or without walnuts. Subjects will be discharged from the CRC after their final testing and after evaluating the milkshake they were consuming on day 5 and will resume their normal diet for a period of 4 weeks after which time they will return to the CRC for a further 5 days for the second study visit. Prior Visit 2 participants will complete another 3-day food diary. If they received placebo milkshake on the first visit, they will have the walnut milkshake on the second visit and vice-versa.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walnut shake | Experimental | Other: Walnut shakeAll 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 |
| Placebo shake | Placebo comparator | Other: Placebo shakeAll 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walnut shakewalnut shake will be administered for 5 days as a morning snack instead of a typical breakfast | Other | Walnut shake |
| Placebo shakeplacebo shake will be administered for 5 days as a morning snack instead of a typical breakfast | Other | Placebo shake |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Derived from this study: PubMed 33541836Tuccinardi 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.
- Derived from this study: PubMed 28715141Farr 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.
- Individual participant dataSharing planned: No. Individual Participant data will be kept confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christos S Mantzoros, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnut shake in people with Obesity, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain centers activation related to food intake assessed using functional magnetic resonance imaging (fMRI) (time frame: fasting Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02673281, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.