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NCT Number: NCT06949280

Metabolic Health, Bones and Nuts 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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Peanut allergies or intolerances
  • Participants with >5% weight loss in the past 6 months or 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, gastrointestinal disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, cardiac, or renal disease.
  • Uncontrolled hypertension or hyperlipidemia in abnormal ranges.
  • History of surgery in the past 6 months or surgical procedure for weight loss in the past 3 years.
  • Regular use of medications that affect bone metabolism, including bisphosphonates or hormone replacement.
  • Regular use of medications for that affect the gastrointestinal tract including incretin mimetics, cholecystitis, urinary tract infection, severe organic diseases including coronary heart disease, myocardial infarction, infectious diseases including pulmonary tuberculosis and AIDS.
  • Antibiotic use in the past month
  • 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

Treatment and study plan

Peanut Snack Experimental

Dietary Supplement

Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss

Nut-free Snack

Dietary Supplement

Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss

Primary outcomes

  1. Bone Mineral Density (BMD - hip)

    Time frame: Change from baseline to 24 weeks

    dual energy x-ray absorptiometry; g/cm2

Secondary outcomes

  1. Soft tissue (lean and fat mass)

    Time frame: Change from baseline to 24 weeks

    dual energy x-ray absorptiometry (kg)

  2. Serum bone turnover

    Time frame: Change from baseline to 24 weeks

    Serum levels (ng/mL) of carboxyterminal crosslinking telopeptide of type I collagen (CTX), procollagen type-I aminoterminal propeptide (PINP), and osteocalcin

  3. Areal BMD

    Time frame: Change from baseline to 24 weeks

    Dual energy x-ray absorptiometry: lumbar spine, femoral neck, radius, total body, g/cm2

  4. Weight loss

    Time frame: Change from baseline to 24 weeks

    Body weight in kg

  5. Trabecular BMD

    Time frame: Change from baseline to 24 weeks

    peripheral quantified computed tomography, g/cm3

  6. Trabecular separation

    Time frame: Change from baseline to 24 weeks

    peripheral quantitative computed tomography, mm

  7. Trabecular bone volume / tissue volume

    Time frame: Change from baseline to 24 weeks

    peripheral quantitative computed tomography, BV/TV (%)

  8. Cortical and total (volumetric BMD)

    Time frame: change from baseline to 24 weeks

    peripheral quantitative computed tomography, g/cm3

  9. Cortical (thickness)

    Time frame: change from baseline to 24 weeks

    peripheral quantitative computed tomography, mm

  10. Cortical (porosity)

    Time frame: change from baseline to 24 weeks

    peripheral quantitative computed tomography, %

  11. Inflammatory Markers

    Time frame: Change from baseline to 24 weeks

    Serum levels of high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α)

  12. Lipid panel

    Time frame: Change in baseline and 24 weeks

    serum LDL, HDL, triglycerides (mg/dL)

  13. Cognition

    Time frame: Change from baseline to 24 weeks

    Neuropsychological Test Automated Battery (CANTAB)

  14. Physical and sleep activity level

    Time frame: change from baseline to 24 weeks

    Time spent in sleep, sedentary activity, and moderate-to-vigorous activity (minutes) using Actigraphy

  15. Sleep architecture (EEG)

    Time frame: Baseline and 24 weeks

    Time spent in rapid eye movement (REM) sleep, and non-REM stages 1-3 sleep (minutes) and as a percentage of total sleep time

  16. Subjective Sleep

    Time frame: Change from baseline to 24 weeks

    Sleep Diary will be used to assess quality of the previous night's sleep using a Likert scale (higher scores reflect higher quality sleep)

  17. Body Temperature (CALERA)

    Time frame: Change from baseline to 24 weeks

    (Core, skin, heat flux)

Other outcomes

  1. Short Physical Performance Battery (SPPB)

    Time frame: Change from baseline to 24 weeks

    Modified SPPB includes chair stand, balance test on1 leg and walk test (0-12; higher score is better)

  2. Arm Curl

    Time frame: Change from baseline to 24 weeks

    Dumbbell weight (More arm curls are better. Score interpretation is age and sex dependent)

  3. Hand Grip

    Time frame: Change from baseline to 24 weeks

    Dynamometer (kilograms, higher is better)

  4. Circumferences

    Time frame: Change from baseline to 24 weeks

    tape measure (waist and hip)

  5. Glucose and insulin

    Time frame: Change from baseline and 24 weeks

    Serum (mg/dL)

  6. Parathyroid hormone

    Time frame: Change from baseline to 24 weeks

    serum (pg/mL)

  7. 25-hydroxyvitamin D (25OHD)

    Time frame: Change from baseline to 24 weeks

    Serum (ng/mL)

  8. Estradiol

    Time frame: Change from baseline to 24 weeks

    serum (pg/mL)

  9. Eating self-efficacy

    Time frame: Change from baseline to 24 weeks

    Weight lifestyle efficacy questionnaire short-form (0-80; higher score is better)

  10. Diet Quality Score

    Time frame: Change from baseline to 24 weeks

    nutrient analysis software (Healthy Eating Index 0-100; higher score is better)

  11. Microbiota

    Time frame: Baseline and 24 weeks

    stool

  12. Blood pressure (systolic and diastolic)

    Time frame: Change from baseline to 24 weeks

    sphygmomanometer (mmHg)

  13. Quality of Sleep

    Time frame: Change from baseline and 24 weeks

    Pittsburgh Sleep Quality Index scores (0-21; higher score is worse)

  14. MRI of the brain

    Time frame: Baseline to 24 weeks

    Tissue/Blood (1 hour of MRI time)

  15. Morningness-Eveningness Questionnaire

    Time frame: Baseline and after 24 weeks

    Score (16-86; higher score is morningness vs low score is eveningness)

Study contacts

Contact information is provided by the study sponsor or research team.

Principal Investigator

CONTACT

[email protected]

848-932-9403

Research Manager

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Metabolic Health, Bones and Nuts Sources of Fatty Acids During Weight Loss in Adults

Acronym: BERN

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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