Salute metabolica, ossa e noci durante la perdita di peso negli adulti (BERN)
Salute metabolica, ossa e noci fonti di acidi grassi durante la perdita di peso negli adulti
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Principal Investigator
- Numero di telefono: 848-932-9403
- Email: shapses@rutgers.edu
Backup dei contatti dello studio
- Nome: Research Manager
- Email: ru-nextnutrition@sebs.rutgers.edu
Luoghi di studio
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New Jersey
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New Brunswick, New Jersey, Stati Uniti, 08901
- Reclutamento
- Rutgers University - NJ Inst Food Nutrition & Health
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Contatto:
- Principal Investigator
- Numero di telefono: 848-932-9403
- Email: shapses@rutgers.edu
-
Contatto:
- Research Manager, MS
- Numero di telefono: 732-455-2062
- Email: ru-nextnutrition@sebs.rutgers.edu
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Peanut
Peanut products |
Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss |
|
Comparatore attivo: Nut-free snack
Nut-free snack |
Subjects will receive a daily no-nut snack and nutrition education-behavior modification instructions for weight loss |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Bone Mineral Density (BMD - total hip)
Lasso di tempo: Change from baseline to 24 weeks
|
dual energy x-ray absorptiometry; g/cm2 |
Change from baseline to 24 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Soft tissue (lean and fat mass)
Lasso di tempo: Change from baseline to 24 weeks
|
dual energy x-ray absorptiometry (kg) |
Change from baseline to 24 weeks
|
|
Serum bone turnover
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Change from baseline to 24 weeks
|
Body weight in kg |
Change from baseline to 24 weeks
|
|
Trabecular BMD
Lasso di tempo: Change from baseline to 24 weeks
|
peripheral quantified computed tomography, g/cm3 |
Change from baseline to 24 weeks
|
|
Trabecular separation
Lasso di tempo: Change from baseline to 24 weeks
|
peripheral quantitative computed tomography, mm |
Change from baseline to 24 weeks
|
|
Trabecular bone volume / tissue volume
Lasso di tempo: Change from baseline to 24 weeks
|
peripheral quantitative computed tomography, BV/TV (%) |
Change from baseline to 24 weeks
|
|
Cortical and total (volumetric BMD)
Lasso di tempo: change from baseline to 24 weeks
|
peripheral quantitative computed tomography, g/cm3 |
change from baseline to 24 weeks
|
|
Cortical (thickness)
Lasso di tempo: change from baseline to 24 weeks
|
peripheral quantitative computed tomography, mm |
change from baseline to 24 weeks
|
|
Cortical (porosity)
Lasso di tempo: change from baseline to 24 weeks
|
peripheral quantitative computed tomography, % |
change from baseline to 24 weeks
|
|
Inflammatory Markers
Lasso di tempo: 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
Lasso di tempo: Change in baseline and 24 weeks
|
serum LDL, HDL, triglycerides (mg/dL) |
Change in baseline and 24 weeks
|
|
Cognition
Lasso di tempo: Change from baseline to 24 weeks
|
Neuropsychological Test Automated Battery (CANTAB) |
Change from baseline to 24 weeks
|
|
Physical and sleep activity level
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Change from baseline to 24 weeks
|
(Core, skin, heat flux) |
Change from baseline to 24 weeks
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Lasso di tempo: 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
Lasso di tempo: 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
|
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Hand Grip
Lasso di tempo: Change from baseline to 24 weeks
|
Dynamometer (kilograms, higher is better) |
Change from baseline to 24 weeks
|
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Circumferences
Lasso di tempo: Change from baseline to 24 weeks
|
tape measure (waist and hip) |
Change from baseline to 24 weeks
|
|
Glucose and insulin
Lasso di tempo: Change from baseline and 24 weeks
|
Serum (mg/dL) |
Change from baseline and 24 weeks
|
|
Parathyroid hormone
Lasso di tempo: Change from baseline to 24 weeks
|
serum (pg/mL) |
Change from baseline to 24 weeks
|
|
25-hydroxyvitamin D (25OHD)
Lasso di tempo: Change from baseline to 24 weeks
|
Serum (ng/mL) |
Change from baseline to 24 weeks
|
|
Estradiol
Lasso di tempo: Change from baseline to 24 weeks
|
serum (pg/mL) |
Change from baseline to 24 weeks
|
|
Eating self-efficacy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline and 24 weeks
|
stool |
Baseline and 24 weeks
|
|
Blood pressure (systolic and diastolic)
Lasso di tempo: Change from baseline to 24 weeks
|
sphygmomanometer (mmHg) |
Change from baseline to 24 weeks
|
|
Quality of Sleep
Lasso di tempo: 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
Lasso di tempo: Baseline to 24 weeks
|
Tissue/Blood (1 hour of MRI time) |
Baseline to 24 weeks
|
|
Morningness-Eveningness Questionnaire
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Change from baseline to 24 weeks
|
Serum Zonulin |
Change from baseline to 24 weeks
|
Collaboratori e investigatori
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pro2023001457
- 1156048 (Altro numero di sovvenzione/finanziamento: TPIF)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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).
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