Metabolic Health, Bones and Nuts During Weight Loss in Adults

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Peanut Snack Experimental
  Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss
• Пищевая добавка Nut-free Snack
  Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss

Первичные конечные точки

• Bone Mineral Density (BMD - hip) [Срок оценки: Change from baseline to 24 weeks]

Вторичные конечные точки (12)

• Soft tissue (lean and fat mass) [Срок оценки: Change from baseline to 24 weeks]
• Serum bone turnover [Срок оценки: Change from baseline to 24 weeks]
• Areal BMD [Срок оценки: Change from baseline to 24 weeks]
• Weight loss [Срок оценки: Change from baseline to 24 weeks]
• Trabecular BMD [Срок оценки: Change from baseline to 24 weeks]
• Trabecular separation [Срок оценки: Change from baseline to 24 weeks]
• Trabecular bone volume / tissue volume [Срок оценки: Change from baseline to 24 weeks]
• Cortical and total (volumetric BMD) [Срок оценки: change from baseline to 24 weeks]
• Cortical (thickness) [Срок оценки: change from baseline to 24 weeks]
• Cortical (porosity) [Срок оценки: change from baseline to 24 weeks]
• Inflammatory Markers [Срок оценки: Change from baseline to 24 weeks]
• Lipid panel [Срок оценки: Change in baseline and 24 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Rutgers University - NJ Inst Food Nutrition & Health — New Brunswick

Идентификаторы

NCT: NCT06949280 · Pro2023001457 · 1156048

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗