Status:
RECRUITING
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Weight Loss
Bone Density
Eligibility:
All Genders
50-75 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06949280
Start Date
May 1 2025
End Date
December 31 2027
Last Update
April 29 2025
Active Locations (1)
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1
Rutgers University - NJ Inst Food Nutrition & Health
New Brunswick, New Jersey, United States, 08901