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Metabole gezondheid, botten en noten tijdens gewichtsverlies bij volwassenen (BERN)

3 november 2026 bijgewerkt door: Sue A. Shapses, Ph.D., RD, Rutgers, The State University of New Jersey

Metabole gezondheid, botten en notenbronnen van vetzuren tijdens gewichtsverlies bij volwassenen

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

44

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Peanut

Peanut products
Voedingssupplement: Peanut Snack Experimental

Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss
Actieve vergelijker: Nut-free snack

Nut-free snack
Voedingssupplement: Nut-free Snack

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Bone Mineral Density (BMD - total hip)
Tijdsspanne: Change from baseline to 24 weeks

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Soft tissue (lean and fat mass)
Tijdsspanne: Change from baseline to 24 weeks

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

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

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

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

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

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

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

peripheral quantitative computed tomography, %
change from baseline to 24 weeks
Inflammatory Markers
Tijdsspanne: 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
Tijdsspanne: Change in baseline and 24 weeks

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

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

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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Short Physical Performance Battery (SPPB)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Change from baseline to 24 weeks

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

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

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

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

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

serum (pg/mL)
Change from baseline to 24 weeks
Eating self-efficacy
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and 24 weeks

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

sphygmomanometer (mmHg)
Change from baseline to 24 weeks
Quality of Sleep
Tijdsspanne: 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
Tijdsspanne: Baseline to 24 weeks

Tissue/Blood (1 hour of MRI time)
Baseline to 24 weeks
Morningness-Eveningness Questionnaire
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Change from baseline to 24 weeks

Serum Zonulin
Change from baseline to 24 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Rutgers, The State University of New Jersey

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 oktober 2025

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

21 maart 2025

Eerst ingediend dat voldeed aan de QC-criteria

21 april 2025

Eerst geplaatst (Werkelijk)

29 april 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Pro2023001457
  • 1156048 (Ander subsidie-/financieringsnummer: TPIF)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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).

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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