Metabolic Health, Bones and Nuts During Weight Loss in Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peanut Snack Experimental, Nut-free Snack.
- Who it may be relevant to
- Registry conditions: Weight Loss, Bone Density, Obesity and Overweight. Basic parameters: 50 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Metabolic Health, Bones and Nuts Sources of Fatty Acids During Weight Loss in Adults
Overview
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.
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.
Interventions
- Dietary supplement Peanut Snack Experimental
Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss - Dietary supplement Nut-free Snack
Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss
Primary outcome measures
- Bone Mineral Density (BMD - hip) [Time frame: Change from baseline to 24 weeks]
Secondary outcome measures (12)
- Soft tissue (lean and fat mass) [Time frame: Change from baseline to 24 weeks]
- Serum bone turnover [Time frame: Change from baseline to 24 weeks]
- Areal BMD [Time frame: Change from baseline to 24 weeks]
- Weight loss [Time frame: Change from baseline to 24 weeks]
- Trabecular BMD [Time frame: Change from baseline to 24 weeks]
- Trabecular separation [Time frame: Change from baseline to 24 weeks]
- Trabecular bone volume / tissue volume [Time frame: Change from baseline to 24 weeks]
- Cortical and total (volumetric BMD) [Time frame: change from baseline to 24 weeks]
- Cortical (thickness) [Time frame: change from baseline to 24 weeks]
- Cortical (porosity) [Time frame: change from baseline to 24 weeks]
- Inflammatory Markers [Time frame: Change from baseline to 24 weeks]
- Lipid panel [Time frame: Change in baseline and 24 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Rutgers University - NJ Inst Food Nutrition & Health — New Brunswick
Identifiers
NCT: NCT06949280 · Pro2023001457 · 1156048