RECRUITING

Metabolic Health, Bones and Nuts During Weight Loss in Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-01
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06949280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and postmenopausal women (\>2 years since last menses), ages 50-75 years
  2. * Body mass index (25-42 kg/m2) or evidence of pre-clinical obesity.
  3. * Agree to be randomly assigned to consume a daily peanut snack or nut-free snack for 24 weeks
  4. * Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)
  1. * Peanut allergies or intolerances
  2. * Participants with \>5% weight loss in the past 6 months or extreme dietary/physical activity habits
  3. * An inability to follow the experimental intervention or to perform the required specimen collections.
  4. * Individuals with significant psychiatric or food disorders.
  5. * Current diagnosis, or history of cancer in past 3 years.
  6. * 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.
  7. * Uncontrolled hypertension or hyperlipidemia in abnormal ranges.
  8. * History of surgery in the past 6 months or surgical procedure for weight loss in the past 3 years.
  9. * Regular use of medications that affect bone metabolism, including bisphosphonates or hormone replacement.
  10. * 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.
  11. * Antibiotic use in the past month
  12. * Alcohol or illicit drug abuse
  13. * 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.
  14. * Participation in another clinical interventional research trial

Contacts and Locations

Study Contact

Principal Investigator
CONTACT
848-932-9403
shapses@rutgers.edu
Research Manager
CONTACT
ru-nextnutrition@sebs.rutgers.edu

Study Locations (Sites)

Rutgers University - NJ Inst Food Nutrition & Health
New Brunswick, New Jersey, 08901
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Weight Loss
  • Bone Density
  • Obesity and Overweight