Metabolic Health, Bones and Nuts Sources of Fatty Acids During Weight Loss in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Bone Mineral Density (BMD - hip)
研究概览
简要总结
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.
详细描述
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
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The statistician is responsible for randomization and blinding other investigators.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Peanut
Peanut products
干预措施: Peanut Snack Experimental (Dietary Supplement)
Nut-free snack
Grain snack (nut-free)
干预措施: Nut-free Snack (Dietary Supplement)
结局指标
主要结局
Bone Mineral Density (BMD - hip)
时间窗: Change from baseline to 24 weeks
dual energy x-ray absorptiometry; g/cm2
次要结局
- Trabecular bone volume / tissue volume(Change from baseline to 24 weeks)
- Cortical and total (volumetric BMD)(change from baseline to 24 weeks)
- Sleep architecture (EEG)(Baseline and 24 weeks)
- Physical and sleep activity level(change from baseline to 24 weeks)
- Subjective Sleep(Change from baseline to 24 weeks)
- Body Temperature (CALERA)(Change from baseline to 24 weeks)
- Soft tissue (lean and fat mass)(Change from baseline to 24 weeks)
- Weight loss(Change from baseline to 24 weeks)
- Areal BMD(Change from baseline to 24 weeks)
- Trabecular BMD(Change from baseline to 24 weeks)
- Trabecular separation(Change from baseline to 24 weeks)
- Cortical (thickness)(change from baseline to 24 weeks)
- Cortical (porosity)(change from baseline to 24 weeks)
- Inflammatory Markers(Change from baseline to 24 weeks)
- Lipid panel(Change in baseline and 24 weeks)
- Cognition(Change from baseline to 24 weeks)
- Serum bone turnover(Change from baseline to 24 weeks)
研究者
Sue A. Shapses, Ph.D., RD
Professor
Rutgers, The State University of New Jersey