Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
225

Summary

Conditions
  • Aging
  • Bone Loss
  • Diet Modification
  • Dietary Habits
  • Fractures, Bone
  • Obesity
  • Osteopenia, Osteoporosis
  • Weight Change, Body
  • Weight Loss
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: All participants will undergo a 6-month weight loss intervention of caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt).Masking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 65 years and 85 years
Gender
Both males and females

Description

The ancillary study to the UPLIFT trial (NCT03074643) will use a 3-group design in 225 obese (BMI 30-45 kg/m2 or 27-<30 kg/m2 with an obesity-related risk factor), older (65-85 years) men and women at risk for disability (SPPB ?10) who will undergo a 6-month weight loss intervention followed by a 12...

The ancillary study to the UPLIFT trial (NCT03074643) will use a 3-group design in 225 obese (BMI 30-45 kg/m2 or 27-<30 kg/m2 with an obesity-related risk factor), older (65-85 years) men and women at risk for disability (SPPB ?10) who will undergo a 6-month weight loss intervention followed by a 12-month follow-up phase to test the overall hypothesis that a higher protein (1.2 g/kg body wt/d) / lower carbohydrate (CHO) diet during a 6-month weight loss intervention improves bone phenotypes compared with an isocaloric lower protein (the current Recommended Dietary Allowance (RDA), 0.8 g/kg body wt/d) / higher CHO diet, and whether continuing a higher protein / lower CHO diet for 12-months following weight loss will result in better maintenance of bone. All participants will undergo a 6-month weight loss intervention involving caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt). Vertebral and femoral volumetric bone mineral density and cortical thickness (Primary Aim) and bone marrow adipose tissue (Secondary Aim 1) will be assessed with computed tomography at baseline, 6-, and 18-months. Bone strength and fracture risk (Secondary Aim 2) will be assessed by finite element modeling at baseline, 6-, and 18-months.

Tracking Information

NCT #
NCT03819478
Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Ashley Weaver, PhD Wake Forest University Health Sciences
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