Utilizing Protein During Weight Loss to Impact Physical Function and Bone
Condition: Obesity; Weight Loss; Diet Modification; Aging; Weight Change, Body; Dietary Habits; Osteopenia, Osteoporosis; Bone Loss; Fractures, Bone
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Body Weight; Weight Loss; Body Weight Changes; Fractures, Bone
Study type: Interventional

Summary: 
      This study is an ancillary study to the Utilizing Protein During Weight Loss to Impact
      Physical Function (UPLIFT) trial (NCT03074643) to evaluate the effects of diet composition
      (i.e., amount of protein and carbohydrate) during a 6-month weight loss intervention and
      12-months of follow-up on bone phenotypes in obese older adults. Participants will receive
      either a protein or carbohydrate supplement along with a behavioral weight loss intervention.
    

Detailed description: 
      The ancillary study to the UPLIFT trial (NCT03074643) will use a 3-group design in 225 obese
      (body mass index [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 (Short Physical Performance Battery,
      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
      weight/day) / 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.
    

Intervention name(s): Weight loss intervention months 0-6; Exercise intervention months 0-6; NutraBio™ CarboMax Supplement; 6-month NutraBio™ 100% Whey Protein Isolate Supplement; 18-month NutraBio™ 100% Whey Protein Isolate Supplement
Intervention type(s): Behavioral; Behavioral; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month).; All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults.; Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (NutraBio™ CarboMax, ~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention.; Participants in the 6-month higher protein / lower CHO diet group (6-mo HiProt) will be provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, ~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention.; Participants in the 18-month higher protein / lower CHO diet (18-mo HiProt) will be provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, ~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and the 12-month follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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