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成人の減量中の代謝の健康、骨、ナッツ (BERN)

2026年11月3日 更新者：Sue A. Shapses, Ph.D., RD、Rutgers, The State University of New Jersey

成人の減量中の脂肪酸の代謝の健康、骨、ナッツ源

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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

44

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • New Jersey
      • New Brunswick、New Jersey、アメリカ、08901
        • 募集
        • Rutgers University - NJ Inst Food Nutrition & Health
        • コンタクト：
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

50年～75年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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
  • Individuals with >5% weight loss in the past 3 months or those with 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 if using insulin, gastrointestinal disease, hyperparathyroidism, Alzheimer's disease, mild cognitive impairment, untreated thyroid disease, significant immune, hepatic, cardiac, or renal disease.
  • History of major surgery in the past 6 months
  • Regular use of medications that affect bone metabolism, including bisphosphonates or hormone replacement.
  • Regular use of medications for cholecystitis, urinary tract infection, severe organic diseases including coronary heart disease, myocardial infarction, infectious diseases including pulmonary tuberculosis and AIDS.
  • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：Peanut

Peanut products
ダイエットサプリメント：Peanut Snack Experimental

Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss
アクティブコンパレータ：Nut-free snack

Nut-free snack
ダイエットサプリメント：Nut-free Snack

Subjects will receive a daily no-nut snack and nutrition education-behavior modification instructions for weight loss

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Bone Mineral Density (BMD - total hip)
時間枠：Change from baseline to 24 weeks

dual energy x-ray absorptiometry; g/cm2
Change from baseline to 24 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Soft tissue (lean and fat mass)
時間枠：Change from baseline to 24 weeks

dual energy x-ray absorptiometry (kg)
Change from baseline to 24 weeks
Serum bone turnover
時間枠：Change from baseline to 24 weeks

Serum levels (ng/mL) of carboxyterminal crosslinking telopeptide of type I collagen (CTX), procollagen type-I aminoterminal propeptide (PINP), and osteocalcin
Change from baseline to 24 weeks
Areal BMD
時間枠：Change from baseline to 24 weeks

Dual energy x-ray absorptiometry: lumbar spine, femoral neck, radius, total body, g/cm2
Change from baseline to 24 weeks
Weight loss
時間枠：Change from baseline to 24 weeks

Body weight in kg
Change from baseline to 24 weeks
Trabecular BMD
時間枠：Change from baseline to 24 weeks

peripheral quantified computed tomography, g/cm3
Change from baseline to 24 weeks
Trabecular separation
時間枠：Change from baseline to 24 weeks

peripheral quantitative computed tomography, mm
Change from baseline to 24 weeks
Trabecular bone volume / tissue volume
時間枠：Change from baseline to 24 weeks

peripheral quantitative computed tomography, BV/TV (%)
Change from baseline to 24 weeks
Cortical and total (volumetric BMD)
時間枠：change from baseline to 24 weeks

peripheral quantitative computed tomography, g/cm3
change from baseline to 24 weeks
Cortical (thickness)
時間枠：change from baseline to 24 weeks

peripheral quantitative computed tomography, mm
change from baseline to 24 weeks
Cortical (porosity)
時間枠：change from baseline to 24 weeks

peripheral quantitative computed tomography, %
change from baseline to 24 weeks
Inflammatory Markers
時間枠：Change from baseline to 24 weeks

Serum levels of high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α)
Change from baseline to 24 weeks
Lipid panel
時間枠：Change in baseline and 24 weeks

serum LDL, HDL, triglycerides (mg/dL)
Change in baseline and 24 weeks
Cognition
時間枠：Change from baseline to 24 weeks

Neuropsychological Test Automated Battery (CANTAB)
Change from baseline to 24 weeks
Physical and sleep activity level
時間枠：change from baseline to 24 weeks

Time spent in sleep, sedentary activity, and moderate-to-vigorous activity (minutes) using Actigraphy
change from baseline to 24 weeks
Sleep architecture (EEG)
時間枠：Baseline and 24 weeks

Time spent in rapid eye movement (REM) sleep, and non-REM stages 1-3 sleep (minutes) and as a percentage of total sleep time
Baseline and 24 weeks
Subjective Sleep
時間枠：Change from baseline to 24 weeks

Sleep Diary will be used to assess quality of the previous night's sleep using a Likert scale (higher scores reflect higher quality sleep)
Change from baseline to 24 weeks
Body Temperature (CALERA)
時間枠：Change from baseline to 24 weeks

(Core, skin, heat flux)
Change from baseline to 24 weeks

その他の成果指標

結果測定
メジャーの説明
時間枠
Short Physical Performance Battery (SPPB)
時間枠：Change from baseline to 24 weeks

Modified SPPB includes chair stand, balance test on1 leg and walk test (0-12; higher score is better)
Change from baseline to 24 weeks
Arm Curl
時間枠：Change from baseline to 24 weeks

Dumbbell weight (More arm curls are better. Score interpretation is age and sex dependent)
Change from baseline to 24 weeks
Hand Grip
時間枠：Change from baseline to 24 weeks

Dynamometer (kilograms, higher is better)
Change from baseline to 24 weeks
Circumferences
時間枠：Change from baseline to 24 weeks

tape measure (waist and hip)
Change from baseline to 24 weeks
Glucose and insulin
時間枠：Change from baseline and 24 weeks

Serum (mg/dL)
Change from baseline and 24 weeks
Parathyroid hormone
時間枠：Change from baseline to 24 weeks

serum (pg/mL)
Change from baseline to 24 weeks
25-hydroxyvitamin D (25OHD)
時間枠：Change from baseline to 24 weeks

Serum (ng/mL)
Change from baseline to 24 weeks
Estradiol
時間枠：Change from baseline to 24 weeks

serum (pg/mL)
Change from baseline to 24 weeks
Eating self-efficacy
時間枠：Change from baseline to 24 weeks

Weight lifestyle efficacy questionnaire short-form (0-80; higher score is better)
Change from baseline to 24 weeks
Diet Quality Score
時間枠：Change from baseline to 24 weeks

nutrient analysis software (Healthy Eating Index 0-100; higher score is better)
Change from baseline to 24 weeks
Microbiota
時間枠：Baseline and 24 weeks

stool
Baseline and 24 weeks
Blood pressure (systolic and diastolic)
時間枠：Change from baseline to 24 weeks

sphygmomanometer (mmHg)
Change from baseline to 24 weeks
Quality of Sleep
時間枠：Change from baseline and 24 weeks

Pittsburgh Sleep Quality Index scores (0-21; higher score is worse)
Change from baseline and 24 weeks
MRI of the brain
時間枠：Baseline to 24 weeks

Tissue/Blood (1 hour of MRI time)
Baseline to 24 weeks
Morningness-Eveningness Questionnaire
時間枠：Baseline and after 24 weeks

Score (16-86; higher score is morningness vs low score is eveningness)
Baseline and after 24 weeks
Biomarkers of brain health
時間枠：Baseline and after 24 weeks

Serum amyloid-beta (42,40) and tau markers (217, 181), BDNF, NfL
Baseline and after 24 weeks
Intestinal Permeability biomarker
時間枠：Change from baseline to 24 weeks

Serum Zonulin
Change from baseline to 24 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Rutgers, The State University of New Jersey

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年10月30日

一次修了 (推定)

2027年12月31日

研究の完了 (推定)

2027年12月31日

試験登録日

最初に提出

2025年3月21日

QC基準を満たした最初の提出物

2025年4月21日

最初の投稿 (実際)

2025年4月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月3日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Pro2023001457
  • 1156048 (その他の助成金/資金番号：TPIF)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data that underlie the results and after deidentification will be shared upon request for researchers who provide a methodologically sound proposal (and IRB approved).

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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