Metabolic Health, Bones and Nuts During Weight Loss in Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorRutgers, The State University of New Jersey

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Peanut Snack Experimental

    Dietary supplement

    Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss

  • Nut-free Snack

    Dietary supplement

    Subjects will receive a daily peanut snack and nutrition education-behavior modification instructions for weight loss

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: PeanutExperimental treatment 1 intervention
Group B: Nut-free snackActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bone Mineral Density (BMD - hip)

dual energy x-ray absorptiometry; g/cm2

Time frame
Change from baseline to 24 weeks

Secondary outcomes

1

Soft tissue (lean and fat mass)

dual energy x-ray absorptiometry (kg)

Time frame
Change from baseline to 24 weeks
2

Serum bone turnover

Serum levels (ng/mL) of carboxyterminal crosslinking telopeptide of type I collagen (CTX), procollagen type-I aminoterminal propeptide (PINP), and osteocalcin

Time frame
Change from baseline to 24 weeks
3

Areal BMD

Dual energy x-ray absorptiometry: lumbar spine, femoral neck, radius, total body, g/cm2

Time frame
Change from baseline to 24 weeks
4

Weight loss

Body weight in kg

Time frame
Change from baseline to 24 weeks

Other outcomes

1

Short Physical Performance Battery (SPPB)

Modified SPPB includes chair stand, balance test on1 leg and walk test (0-12; higher score is better)

Time frame
Change from baseline to 24 weeks
2

Arm Curl

Dumbbell weight (More arm curls are better. Score interpretation is age and sex dependent)

Time frame
Change from baseline to 24 weeks
3

Hand Grip

Dynamometer (kilograms, higher is better)

Time frame
Change from baseline to 24 weeks
4

Circumferences

tape measure (waist and hip)

Time frame
Change from baseline to 24 weeks

Sponsors and contacts

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