Stoffwechselgesundheit, Knochen und Nüsse beim Gewichtsverlust bei Erwachsenen (BERN)
Stoffwechselgesundheit, Knochen und Nüsse Quellen für Fettsäuren während des Gewichts von Erwachsenen
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Principal Investigator
- Telefonnummer: 848-932-9403
- E-Mail: shapses@rutgers.edu
Studieren Sie die Kontaktsicherung
- Name: Research Manager
- E-Mail: ru-nextnutrition@sebs.rutgers.edu
Studienorte
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New Jersey
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New Brunswick, New Jersey, Vereinigte Staaten, 08901
- Rekrutierung
- Rutgers University - NJ Inst Food Nutrition & Health
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Kontakt:
- Principal Investigator
- Telefonnummer: 848-932-9403
- E-Mail: shapses@rutgers.edu
-
Kontakt:
- Research Manager, MS
- Telefonnummer: 732-455-2062
- E-Mail: ru-nextnutrition@sebs.rutgers.edu
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Peanut
Peanut products |
Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss |
|
Aktiver Komparator: Nut-free snack
Nut-free snack |
Subjects will receive a daily no-nut snack and nutrition education-behavior modification instructions for weight loss |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Bone Mineral Density (BMD - total hip)
Zeitfenster: Change from baseline to 24 weeks
|
dual energy x-ray absorptiometry; g/cm2 |
Change from baseline to 24 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Soft tissue (lean and fat mass)
Zeitfenster: Change from baseline to 24 weeks
|
dual energy x-ray absorptiometry (kg) |
Change from baseline to 24 weeks
|
|
Serum bone turnover
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Change from baseline to 24 weeks
|
Body weight in kg |
Change from baseline to 24 weeks
|
|
Trabecular BMD
Zeitfenster: Change from baseline to 24 weeks
|
peripheral quantified computed tomography, g/cm3 |
Change from baseline to 24 weeks
|
|
Trabecular separation
Zeitfenster: Change from baseline to 24 weeks
|
peripheral quantitative computed tomography, mm |
Change from baseline to 24 weeks
|
|
Trabecular bone volume / tissue volume
Zeitfenster: Change from baseline to 24 weeks
|
peripheral quantitative computed tomography, BV/TV (%) |
Change from baseline to 24 weeks
|
|
Cortical and total (volumetric BMD)
Zeitfenster: change from baseline to 24 weeks
|
peripheral quantitative computed tomography, g/cm3 |
change from baseline to 24 weeks
|
|
Cortical (thickness)
Zeitfenster: change from baseline to 24 weeks
|
peripheral quantitative computed tomography, mm |
change from baseline to 24 weeks
|
|
Cortical (porosity)
Zeitfenster: change from baseline to 24 weeks
|
peripheral quantitative computed tomography, % |
change from baseline to 24 weeks
|
|
Inflammatory Markers
Zeitfenster: 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
Zeitfenster: Change in baseline and 24 weeks
|
serum LDL, HDL, triglycerides (mg/dL) |
Change in baseline and 24 weeks
|
|
Cognition
Zeitfenster: Change from baseline to 24 weeks
|
Neuropsychological Test Automated Battery (CANTAB) |
Change from baseline to 24 weeks
|
|
Physical and sleep activity level
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: Change from baseline to 24 weeks
|
(Core, skin, heat flux) |
Change from baseline to 24 weeks
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Change from baseline to 24 weeks
|
Dynamometer (kilograms, higher is better) |
Change from baseline to 24 weeks
|
|
Circumferences
Zeitfenster: Change from baseline to 24 weeks
|
tape measure (waist and hip) |
Change from baseline to 24 weeks
|
|
Glucose and insulin
Zeitfenster: Change from baseline and 24 weeks
|
Serum (mg/dL) |
Change from baseline and 24 weeks
|
|
Parathyroid hormone
Zeitfenster: Change from baseline to 24 weeks
|
serum (pg/mL) |
Change from baseline to 24 weeks
|
|
25-hydroxyvitamin D (25OHD)
Zeitfenster: Change from baseline to 24 weeks
|
Serum (ng/mL) |
Change from baseline to 24 weeks
|
|
Estradiol
Zeitfenster: Change from baseline to 24 weeks
|
serum (pg/mL) |
Change from baseline to 24 weeks
|
|
Eating self-efficacy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline and 24 weeks
|
stool |
Baseline and 24 weeks
|
|
Blood pressure (systolic and diastolic)
Zeitfenster: Change from baseline to 24 weeks
|
sphygmomanometer (mmHg) |
Change from baseline to 24 weeks
|
|
Quality of Sleep
Zeitfenster: 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
Zeitfenster: Baseline to 24 weeks
|
Tissue/Blood (1 hour of MRI time) |
Baseline to 24 weeks
|
|
Morningness-Eveningness Questionnaire
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Change from baseline to 24 weeks
|
Serum Zonulin |
Change from baseline to 24 weeks
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Pro2023001457
- 1156048 (Andere Zuschuss-/Finanzierungsnummer: TPIF)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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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