Metabolic Health, Bones and Nuts During Weight Loss in Adults

NCT06949280 | Recruiting

• 2 other identifiers: Pro20230014571156048
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Weight Loss; Bone Density; Obesity and Overweight

Keywords

weight loss; adults; bone; cognition; metabolic health; sleep; peanut; Monounsaturated fatty acid

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density (BMD - hip)

  dual energy x-ray absorptiometry; g/cm2

  Change from baseline to 24 weeks

Secondary Outcomes (14)

• Soft tissue (lean and fat mass)

  Change from baseline to 24 weeks

• Serum bone turnover

  Change from baseline to 24 weeks

• Areal BMD

  Change from baseline to 24 weeks

• Weight loss

  Change from baseline to 24 weeks

• Trabecular BMD

  Change from baseline to 24 weeks

Other Outcomes (12)

• Short Physical Performance Battery (SPPB)

  Change from baseline to 24 weeks

• Arm Curl

  Change from baseline to 24 weeks

• Hand Grip

  Change from baseline to 24 weeks

Study Arms (2)

Peanut

EXPERIMENTAL

Peanut products

Dietary Supplement: Peanut Snack Experimental

Nut-free snack

ACTIVE COMPARATOR

Grain snack (nut-free)

Dietary Supplement: Nut-free Snack

Interventions

Peanut Snack Experimental DIETARY_SUPPLEMENT

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

Peanut

Nut-free Snack DIETARY_SUPPLEMENT

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

Nut-free snack

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University - NJ Inst Food Nutrition & Health

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Weight Loss; Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Principal Investigator

CONTACT

848-932-9403; shapses@rutgers.edu

Research Manager

CONTACT

ru-nextnutrition@sebs.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The statistician is responsible for randomization and blinding other investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 29, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)