NCT02437643

Brief Summary

The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from dairy and other animal source proteins) with calorie restriction and low-intensity exercise on muscle quality and muscle adipose infiltration (along with bone mineral density \[BMD\] and a number of secondary outcomes) in frail, obese, older adults participating in a 6 month intervention. The investigators will compare these effects to those of a traditional control regimen of calorie restriction and low-intensity exercise over the same duration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 17, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

3.2 years

First QC Date

May 5, 2015

Last Update Submit

November 6, 2018

Conditions

DynapeniaObesity

Outcome Measures

Primary Outcomes (2)

  • Change in muscle quality

    composite score of time to perform ten chair rises, height of the chair, leg length, body mass, and acceleration of gravity in relation to muscle mass

    baseline, 3 months, 6 months

  • Change in muscle adipose infiltration

    CT-scan

    baseline, 3 months, 6 months

Secondary Outcomes (18)

  • Change in Physical Function

    baseline, 3 months, 6 months

  • Change in Body weight

    baseline, 3 months, 6 months

  • Change in lean Body Mass

    baseline, 3 months, 6 months

  • Change in lean Body Mass

    baseline, 3 months, 6 months

  • Change in fat mass

    baseline, 3 months, 6 months

  • +13 more secondary outcomes

Study Arms (2)

WL-LoEX

PLACEBO COMPARATOR

10% Weight loss diet plus low intensity exercise (protein \~0.8g/kg). Participants will be provided one serving of dairy protein daily.

Behavioral: Weight LossDietary Supplement: Dairy ProteinBehavioral: Low intensity exercise

Pro-WL-LoEX

ACTIVE COMPARATOR

Protein-enhanced 10% Weight loss diet plus low intensity exercise (protein \~1.2 g/kg with \> 30g per meal and \>60% as dairy). Participants will be provided at least 8 servings of dairy protein daily.

Behavioral: Weight LossDietary Supplement: Dairy ProteinBehavioral: Low intensity exercise

Interventions

Weight LossBEHAVIORAL

Participants will be prescribed hypo-caloric diet prescription.

Pro-WL-LoEXWL-LoEX
Dairy ProteinDIETARY_SUPPLEMENT

Participants will be provided dairy products: WL-LoEx will be provided 1 dairy serving per day and Pro-WL-LoEx will be provided 8 dairy servings per day.

Pro-WL-LoEXWL-LoEX
Low intensity exerciseBEHAVIORAL

Participants in both groups will participate in chair exercises 3 times a week.

Pro-WL-LoEXWL-LoEX

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>30;
  • SPPB score of ≥4 to \<10;
  • GFR \<45 mL/min

You may not qualify if:

  • Body weight \>495 lbs. (BodPod limits);
  • estimated glomerular filtration rates (eGFR) less than 45 mL/min;
  • symptomatic cardiac disease;
  • receiving chemotherapy;
  • hemophilia;
  • presence of unstable or symptomatic life-threatening illness;
  • neurological disease or disorder causing functional impairments;
  • inability to walk,
  • dementia;
  • prescription weight loss medications;
  • use of monamine oxidase inhibitors (MAOIs); or
  • primary medical provider advises against participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Miller MG, Porter Starr KN, Rincker J, Orenduff MC, McDonald SR, Pieper CF, Fruik AR, Lyles KW, Bales CW. Rationale and Design for a Higher (Dairy) Protein Weight Loss Intervention That Promotes Muscle Quality and Bone Health in Older Adults with Obesity: A Randomized, Controlled Pilot Study. J Nutr Gerontol Geriatr. 2021 Apr-Jun;40(2-3):150-170. doi: 10.1080/21551197.2021.1896615. Epub 2021 Mar 13.

    PMID: 33719918DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Connie Bales, PhD, RD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 7, 2015

Study Start

August 17, 2015

Primary Completion

October 15, 2018

Study Completion

October 15, 2018

Last Updated

November 7, 2018

Record last verified: 2018-11

Locations

US(1)