Metabolic Health, Bones and Nuts During Weight Loss in Adults (BERN)

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.

Study Overview

• Status: Recruiting
• Conditions: Weight Loss; Bone Density; Obesity and Overweight
• Intervention / Treatment: Dietary supplement: Peanut Snack Experimental; Dietary supplement: Nut-free Snack

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

1. 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.
2. 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 Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: 848-932-9403; Email: shapses@rutgers.edu
• Study Contact Backup: Name: Research Manager; Email: ru-nextnutrition@sebs.rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers University - NJ Inst Food Nutrition & Health
      • Contact: Principal Investigator; Phone Number: 848-932-9403; Email: shapses@rutgers.edu
      • Contact: Research Manager, MS; Phone Number: 732-455-2062; Email: ru-nextnutrition@sebs.rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peanut; Peanut products	Dietary supplement: Peanut Snack Experimental; Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss
Active Comparator: Nut-free snack; Grain snack (nut-free)	Dietary supplement: Nut-free Snack; Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Mineral Density (BMD - hip)	dual energy x-ray absorptiometry; g/cm2	Change from baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue (lean and fat mass)	dual energy x-ray absorptiometry (kg)	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	Change from baseline to 24 weeks
Areal BMD	Dual energy x-ray absorptiometry: lumbar spine, femoral neck, radius, total body, g/cm2	Change from baseline to 24 weeks
Weight loss	Body weight in kg	Change from baseline to 24 weeks
Trabecular BMD	peripheral quantified computed tomography, g/cm3	Change from baseline to 24 weeks
Trabecular separation	peripheral quantitative computed tomography, mm	Change from baseline to 24 weeks
Trabecular bone volume / tissue volume	peripheral quantitative computed tomography, BV/TV (%)	Change from baseline to 24 weeks
Cortical and total (volumetric BMD)	peripheral quantitative computed tomography, g/cm3	change from baseline to 24 weeks
Cortical (thickness)	peripheral quantitative computed tomography, mm	change from baseline to 24 weeks
Cortical (porosity)	peripheral quantitative computed tomography, %	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)	Change from baseline to 24 weeks
Lipid panel	serum LDL, HDL, triglycerides (mg/dL)	Change in baseline and 24 weeks
Cognition	Neuropsychological Test Automated Battery (CANTAB)	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	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	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)	Change from baseline to 24 weeks
Body Temperature (CALERA)	(Core, skin, heat flux)	Change from baseline to 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery (SPPB)	Modified SPPB includes chair stand, balance test on1 leg and walk test (0-12; higher score is better)	Change from baseline to 24 weeks
Arm Curl	Dumbbell weight (More arm curls are better. Score interpretation is age and sex dependent)	Change from baseline to 24 weeks
Hand Grip	Dynamometer (kilograms, higher is better)	Change from baseline to 24 weeks
Circumferences	tape measure (waist and hip)	Change from baseline to 24 weeks
Glucose and insulin	Serum (mg/dL)	Change from baseline and 24 weeks
Parathyroid hormone	serum (pg/mL)	Change from baseline to 24 weeks
25-hydroxyvitamin D (25OHD)	Serum (ng/mL)	Change from baseline to 24 weeks
Estradiol	serum (pg/mL)	Change from baseline to 24 weeks
Eating self-efficacy	Weight lifestyle efficacy questionnaire short-form (0-80; higher score is better)	Change from baseline to 24 weeks
Diet Quality Score	nutrient analysis software (Healthy Eating Index 0-100; higher score is better)	Change from baseline to 24 weeks
Microbiota	stool	Baseline and 24 weeks
Blood pressure (systolic and diastolic)	sphygmomanometer (mmHg)	Change from baseline to 24 weeks
Quality of Sleep	Pittsburgh Sleep Quality Index scores (0-21; higher score is worse)	Change from baseline and 24 weeks
MRI of the brain	Tissue/Blood (1 hour of MRI time)	Baseline to 24 weeks
Morningness-Eveningness Questionnaire	Score (16-86; higher score is morningness vs low score is eveningness)	Baseline and after 24 weeks

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: sleep; cognition; weight loss; bone; adults; peanut; metabolic health; Monounsaturated fatty acid
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Weight Loss
• Other Study ID Numbers: Pro2023001457; 1156048 (Other Grant/Funding Number: TPIF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No