Weight LossBERNNCT06949280
Metabolic Health, Bones and Nuts During Weight Loss in Adults
A study testing Peanut Snack Experimental and Nut-free Snack in people with Weight Loss and Bone Density, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice but are not consumed frequently enough in older… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Bone Density, Obesity and Overweight
- What is being tested?
- Peanut Snack Experimental and Nut-free Snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and postmenopausal women (>2 years since last menses), ages 50-75 years
- Body mass index (25-42 kg/m2) or evidence of pre-clinical obesity.
- Agree to be randomly assigned to consume a daily peanut snack or nut-free snack for 24 weeks
- Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)
Who cannot join
- Peanut allergies or intolerances
- Individuals with >5% weight loss in the past 3 months or those with extreme dietary/physical activity habits.
- An inability to follow the experimental intervention or to perform the required specimen collections.
- Individuals with significant psychiatric or food disorders.
- Current diagnosis, or history of cancer in past 3 years.
- Current diagnosis or history of bone diseases, type I or II diabetes if using insulin, gastrointestinal disease, hyperparathyroidism, Alzheimer's disease, mild cognitive impairment, untreated thyroid disease, significant immune, hepatic, cardiac, or renal disease.
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- History of major surgery in the past 6 months
- Regular use of medications that affect bone metabolism, including bisphosphonates or hormone replacement.
- Regular use of medications for cholecystitis, urinary tract infection, severe organic diseases including coronary heart disease, myocardial infarction, infectious diseases including pulmonary tuberculosis and AIDS.
- Alcohol or illicit drug abuse
- Any other condition deemed by the Research Physician that would prevent participation in the study, e.g. participation in another clinical research project that may interfere with the results of this study.
- Participation in another clinical interventional research trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Research Manager contact
United States1 site, 1 recruiting
- Recruiting
Rutgers University - NJ Inst Food Nutrition & Health
New Brunswick, New Jersey, 08901
Principal Investigator, 848-932-9403, shapses@rutgers.edu
Research Manager, MS, 732-455-2062, ru-nextnutrition@sebs.rutgers.edu
About this study
Official title: Metabolic Health, Bones and Nuts Sources of Fatty Acids During Weight Loss in Adults
The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain, and several dietary pattern studies indicate that nuts and legumes are associated with better bone health. In addition, our preliminary translational data indicates that a higher monounsaturated fatty acid (MUFA) intake is associated with improved bone mineral density (BMD) and quality. Given these findings, the proposed study aims to examine the impact of consuming peanut products on bone health, metabolic health (e.g., serum glucose, insulin, lipids and inflammation), markers of brain and sleep health, and physical function in overweight and obese older adults before and after a six-month weight loss intervention using a randomized controlled design. The results of this study have the potential to provide valuable insights into the role of peanuts as a sources of fatty acids in promoting health and preventing disease in at-risk adults.
Read the detailed description
The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain, and several dietary pattern studies indicate that nuts and legumes are associated with better bone health. In addition, our preliminary translational data indicates that a higher monounsaturated fatty acid (MUFA) intake is associated with improved bone mineral density (BMD) and quality. Given these findings, the proposed study aims to examine the impact of consuming peanut products on bone health, metabolic health (e.g., serum glucose, insulin, lipids and inflammation), markers of brain and sleep health, and physical function in overweight and obese older adults before and after a six-month weight loss intervention using a randomized controlled design. The results of this study have the potential to provide valuable insights into the role of peanuts as a sources of fatty acids in promoting health and preventing disease in at-risk adults.
Specific Aims
- To determine whether consuming peanuts daily compared to a control group (no nuts) during lifestyle intervention has a differential effect on bone mineral density in older adults who are overweight or obese.
- To determine the temporal change in bone turnover biomarkers and bone regulating hormones during weight loss in the diet in older adults with overweight or obesity. Exploratory outcomes will examine metabolic biomarkers (serum glucose, insulin, lipid levels), brain (MRI and biomarkers) and sleep health and physical function.
- Conditions
- Weight Loss, Bone Density, Obesity and Overweight
- Being tested
- Peanut Snack Experimental, Nut-free Snack
- Keywords
- weight loss, adults, bone, cognition, metabolic health, sleep, peanut, Monounsaturated fatty acid
- Medical subject headings
- Weight Loss, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut Snack ExperimentalDietary supplement
Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss
Nut-free SnackDietary supplement
Subjects will receive a daily no-nut snack and nutrition education-behavior modification instructions for weight loss
| Study group | Role | What they receive |
|---|---|---|
| Peanut | Experimental | Peanut products Receives: Dietary Supplement: Peanut Snack Experimental |
| Nut-free snack | Active comparator | Nut-free snack Receives: Dietary Supplement: Nut-free Snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density (BMD - total hip)
dual energy x-ray absorptiometry; g/cm2
Measured: Change from baseline to 24 weeks
Secondary outcomes (17)
Soft tissue (lean and fat mass)
dual energy x-ray absorptiometry (kg)
Measured: Change from baseline to 24 weeks
Serum bone turnover
Serum levels (ng/mL) of carboxyterminal crosslinking telopeptide of type I collagen (CTX), procollagen type-I aminoterminal propeptide (PINP), and osteocalcin
Measured: Change from baseline to 24 weeks
Areal BMD
Dual energy x-ray absorptiometry: lumbar spine, femoral neck, radius, total body, g/cm2
Measured: Change from baseline to 24 weeks
Weight loss
Body weight in kg
Measured: Change from baseline to 24 weeks
Trabecular BMD
peripheral quantified computed tomography, g/cm3
Measured: Change from baseline to 24 weeks
Trabecular separation
peripheral quantitative computed tomography, mm
Measured: Change from baseline to 24 weeks
Trabecular bone volume / tissue volume
peripheral quantitative computed tomography, BV/TV (%)
Measured: Change from baseline to 24 weeks
Cortical and total (volumetric BMD)
peripheral quantitative computed tomography, g/cm3
Measured: change from baseline to 24 weeks
Cortical (thickness)
peripheral quantitative computed tomography, mm
Measured: change from baseline to 24 weeks
Cortical (porosity)
peripheral quantitative computed tomography, %
Measured: change from baseline to 24 weeks
Inflammatory Markers
Serum levels of high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α)
Measured: Change from baseline to 24 weeks
Lipid panel
serum LDL, HDL, triglycerides (mg/dL)
Measured: Change in baseline and 24 weeks
Cognition
Neuropsychological Test Automated Battery (CANTAB)
Measured: Change from baseline to 24 weeks
Physical and sleep activity level
Time spent in sleep, sedentary activity, and moderate-to-vigorous activity (minutes) using Actigraphy
Measured: change from baseline to 24 weeks
Sleep architecture (EEG)
Time spent in rapid eye movement (REM) sleep, and non-REM stages 1-3 sleep (minutes) and as a percentage of total sleep time
Measured: Baseline and 24 weeks
Subjective Sleep
Sleep Diary will be used to assess quality of the previous night's sleep using a Likert scale (higher scores reflect higher quality sleep)
Measured: Change from baseline to 24 weeks
Body Temperature (CALERA)
(Core, skin, heat flux)
Measured: Change from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start30 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue A. Shapses, Ph.D., RD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949280
- Sponsor's protocol ID
- Pro2023001457
- Other IDs
- 1156048
- Acronym
- BERN
- Status last verified
- May 2026
- First submitted
- 21 Mar 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data that underlie the results and after deidentification will be shared upon request for researchers who provide a methodologically sound proposal (and IRB approved).
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Health, Bones and Nuts Sources of Fatty Acids During Weight Loss in Adults
- ClinicalTrials.gov ID
- NCT06949280
- Acronym / sponsor ID
- BERN / Pro2023001457
- Conditions
- Weight Loss, Bone Density, Obesity and Overweight
- Keywords
- weight loss, adults, bone, cognition, metabolic health, sleep, peanut, Monounsaturated fatty acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Apr 2025 (actual)
- 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 aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain, and several dietary pattern studies indicate that nuts and legumes are associated with better bone health. In addition, our preliminary translational data indicates that a higher monounsaturated fatty acid (MUFA) intake is associated with improved bone mineral density (BMD) and quality. Given these findings, the proposed study aims to examine the impact of consuming peanut products on bone health, metabolic health (e.g., serum glucose, insulin, lipids and inflammation), markers of brain and sleep health, and physical function in overweight and obese older adults before and after a six-month weight loss intervention using a randomized controlled design. The results of this study have the potential to provide valuable insights into the role of peanuts as a sources of fatty acids in promoting health and preventing disease in at-risk adults.
Detailed description
The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain, and several dietary pattern studies indicate that nuts and legumes are associated with better bone health. In addition, our preliminary translational data indicates that a higher monounsaturated fatty acid (MUFA) intake is associated with improved bone mineral density (BMD) and quality. Given these findings, the proposed study aims to examine the impact of consuming peanut products on bone health, metabolic health (e.g., serum glucose, insulin, lipids and inflammation), markers of brain and sleep health, and physical function in overweight and obese older adults before and after a six-month weight loss intervention using a randomized controlled design. The results of this study have the potential to provide valuable insights into the role of peanuts as a sources of fatty acids in promoting health and preventing disease in at-risk adults.
Specific Aims
- To determine whether consuming peanuts daily compared to a control group (no nuts) during lifestyle intervention has a differential effect on bone mineral density in older adults who are overweight or obese.
- To determine the temporal change in bone turnover biomarkers and bone regulating hormones during weight loss in the diet in older adults with overweight or obesity. Exploratory outcomes will examine metabolic biomarkers (serum glucose, insulin, lipid levels), brain (MRI and biomarkers) and sleep health and physical function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Peanut | Experimental | Dietary Supplement: Peanut Snack ExperimentalPeanut products |
| Nut-free snack | Active comparator | Dietary Supplement: Nut-free SnackNut-free snack |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and postmenopausal women (>2 years since last menses), ages 50-75 years
- Body mass index (25-42 kg/m2) or evidence of pre-clinical obesity.
- Agree to be randomly assigned to consume a daily peanut snack or nut-free snack for 24 weeks
- Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)
Key exclusion criteria (12 listed)
- Peanut allergies or intolerances
- Individuals with >5% weight loss in the past 3 months or those with extreme dietary/physical activity habits.
- An inability to follow the experimental intervention or to perform the required specimen collections.
- Individuals with significant psychiatric or food disorders.
- Current diagnosis, or history of cancer in past 3 years.
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 |
|---|---|---|
| Peanut Snack ExperimentalSubjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss | Dietary supplement | Peanut |
| Nut-free SnackSubjects will receive a daily no-nut snack and nutrition education-behavior modification instructions for weight loss | Dietary supplement | Nut-free snack |
Primary outcome
Bone Mineral Density (BMD - total hip)
Time frame: Change from baseline to 24 weeks
dual energy x-ray absorptiometry; g/cm2
17 secondary outcomes
Soft tissue (lean and fat mass)
Time frame: Change from baseline to 24 weeks
Serum bone turnover
Time frame: Change from baseline to 24 weeks
Areal BMD
Time frame: Change from baseline to 24 weeks
Weight loss
Time frame: Change from baseline to 24 weeks
Trabecular BMD
Time frame: Change from baseline to 24 weeks
Trabecular separation
Time frame: Change from baseline to 24 weeks
Trabecular bone volume / tissue volume
Time frame: Change from baseline to 24 weeks
Cortical and total (volumetric BMD)
Time frame: change from baseline to 24 weeks
Cortical (thickness)
Time frame: change from baseline to 24 weeks
Cortical (porosity)
Time frame: change from baseline to 24 weeks
Inflammatory Markers
Time frame: Change from baseline to 24 weeks
Lipid panel
Time frame: Change in baseline and 24 weeks
Cognition
Time frame: Change from baseline to 24 weeks
Physical and sleep activity level
Time frame: change from baseline to 24 weeks
Sleep architecture (EEG)
Time frame: Baseline and 24 weeks
Subjective Sleep
Time frame: Change from baseline to 24 weeks
Body Temperature (CALERA)
Time frame: Change from baseline to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data that underlie the results and after deidentification will be shared upon request for researchers who provide a methodologically sound proposal (and IRB approved).
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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.
Research Manager contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut Snack Experimental and Nut-free Snack in people with Weight Loss and Bone Density, run by Rutgers, The State University of New Jersey 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (848-932-9403, shapses@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (BMD - total hip) (time frame: Change from baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.