Utilizing Protein During Weight Loss to Impact Physical Function and Bone

NCT03819478 | Completed Results DMC

• 3 other identifiers: IRB00038668-AIRB00038668K25AG058804
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Weight Loss; Diet Modification; Aging; Weight Change, Body; Dietary Habits; Osteopenia, Osteoporosis; Bone Loss; Fractures, Bone

Outcome Measures

Primary Outcomes (1)

• 18-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3

  To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in total hip trabecular volumetric bone mineral density (vBMD). Total hip trabecular vBMD (in mg/cm\^3) was measured from the baseline and 18-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vBMD measures. The 18-month change in total hip trabecular vBMD from baseline is reported for this outcome measure.

  Change from Baseline to Month 18

Secondary Outcomes (9)

• 6-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm

  Change from Baseline to Month 6

• 18-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm

  Change from Baseline to Month 18

• 6-month Change From Baseline in Femoral Bone Strength in kN

  Change from Baseline to Month 6

• 18-month Change From Baseline in Femoral Bone Strength in kN

  Change from Baseline to Month 18

• 18-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm

  Change from Baseline to Month 18

Study Arms (3)

RecProt

ACTIVE COMPARATOR

Subjects receiving the following interventions in the parent trial (UPLIFT; NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.

Behavioral: Weight loss intervention months 0-6; Behavioral: Exercise intervention months 0-6; Dietary Supplement: NutraBio™ CarboMax Supplement

6-mo HiProt

ACTIVE COMPARATOR

Subjects receiving the following interventions in the parent trial (UPLIFT; NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.

Behavioral: Weight loss intervention months 0-6; Behavioral: Exercise intervention months 0-6; Dietary Supplement: 6-month NutraBio™ 100% Whey Protein Isolate Supplement

18-mo HiProt

ACTIVE COMPARATOR

Subjects receiving the following interventions in the parent trial (UPLIFT; NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18.

Behavioral: Weight loss intervention months 0-6; Behavioral: Exercise intervention months 0-6; Dietary Supplement: 18-month NutraBio™ 100% Whey Protein Isolate Supplement

Interventions

Weight loss intervention months 0-6 BEHAVIORAL

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).

18-mo HiProt; 6-mo HiProt; RecProt

Exercise intervention months 0-6 BEHAVIORAL

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.

18-mo HiProt; 6-mo HiProt; RecProt

NutraBio™ CarboMax Supplement DIETARY_SUPPLEMENT

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.

RecProt

6-month NutraBio™ 100% Whey Protein Isolate Supplement DIETARY_SUPPLEMENT

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.

6-mo HiProt

18-month NutraBio™ 100% Whey Protein Isolate Supplement DIETARY_SUPPLEMENT

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.

18-mo HiProt

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• years
• BMI: 30-45 kg/m2 or BMI 27.0 - \<30.0 AND at least one of the following risk factors:
• elevated waist circumference (\>35 inches in women, \>40 inches in men)
• diabetes,
• hypertension,
• dyslipidemia,
• or other obesity-related comorbidities: clinically manifest coronary artery disease \[e.g., history of myocardial infarction, angina pectoris, coronary artery surgery, coronary artery procedures (e.g., angioplasty) if not within the past year\], other atherosclerotic disease \[e.g., peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease if not within the past year\], sleep apnea, or osteoarthritis of the knee or hip.
• No regular resistance training and/or aerobic exercise (\>20 mins/d) for past 6 months
• SPPB ≥3 to ≤10
• No contraindications for safe and optimal participation in exercise training
• Approved for participation by Medical Director (Dr. Lyles)
• Willing to provide informed consent
• Agree to all study procedures and assessments
• Willing to consume protein/CHO supplements for up to 18 months
• Able to provide own transportation to study visits and intervention sessions

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Geriatric Research Center at Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Body Weight Changes; Feeding Behavior; Bone Diseases, Metabolic; Fractures, Bone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Wounds and Injuries

Limitations and Caveats

We initially planned to end recruitment in August of 2020. However, our institution paused all in-person research from March 13, 2020 through May 31, 2020 due to the COVID19 pandemic. We extended our recruitment window through September 2020 but did not reach our target enrollment. The COVID19 pandemic also affected participant follow-up (a large number of out of window visits and a few who refused to return for in-person visits). The 6-month intervention also had to go remote for \~4 months.

Results Point of Contact

• Title: Ashley Weaver, PhD
• Organization: Wake Forest University Health Sciences

asweaver@wakehealth.edu

336-716-0944

Study Officials

• Ashley Weaver, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 28, 2019
• Study Start: May 3, 2017
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: January 19, 2024
• Results First Posted: January 19, 2024

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)