Clinical trial

Metabolic Health, Bones and Nuts During Weight Loss in Adults

Recruiting now · Not applicable · 1 countries · Registry ID NCT06949280

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age50 Years to 75 Years
SexAll
Healthy volunteersAccepted
ConditionWeight Loss, Bone Density, Obesity and Overweight

Full registry criteria

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

Treatments and study arms

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

Bone Mineral Density (BMD - hip)Change from baseline to 24 weeks

dual energy x-ray absorptiometry; g/cm2

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Rutgers University - NJ Inst Food Nutrition & Health🇺🇸 New Brunswick, New Jersey, United States
Principal InvestigatorContact
Research Manager, MSContact