An Enhanced Protein (Dairy) Weight Loss Intervention for Dynapenic Obesity: Impact on Muscle Quality and Composition (DDYNAMO)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Dynapenia
• Intervention / Treatment: Behavioral: Weight Loss; Dietary supplement: Dairy Protein; Behavioral: Low intensity exercise

Detailed Description

Obese older adults (≥60 yrs) with moderate functional impairment will be randomized to 1 of 2 study arms. Outcomes to be measured at 0, 3 and 6 months are as follows: Primary outcomes- (1) Muscle Quality (MQ): muscle power (time to perform ten chair rises, height of the chair, leg length, body mass, and acceleration of gravity) in relation to muscle mass (CT-scan) and (2) Muscle adipose infiltration (MAI) (CT-scan). Secondary outcomes- Bone Mineral Density (BMD; DXA scan) physical function (Short Physical Performance Battery (SPPB); 6 minute walk; 8-foot up and go; and 30 second chair stands; handgrip strength; body weight; fat mass; waist circumference; activity (accelerometers); mental health (sleep, depression, quality of life); and feasibility factors (adherence, protein intake, nutrition adequacy). BMD will only be accessed at 0 and 6 months.

Study Arms:

• Weight loss plus low-intensity exercise intervention (WL-LoEX; n = 35): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein~0.8g/g/d. Subjects will also participate in three 30-minute low-intensity exercise sessions weekly. One serving of dairy protein/day will be provided to WL-LoEX participants.
• High protein weight loss plus low-intensity exercise intervention (PRO-WL-LoEX; n = 35): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal sources (high quality) and 60-70% of animal protein from dairy foods that will be provided. Subjects will also participate in three 30-minute low-intensity exercise sessions weekly.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: WL-LoEX; 10% Weight loss diet plus low intensity exercise (protein ~0.8g/kg). Participants will be provided one serving of dairy protein daily.	Behavioral: Weight Loss; Participants will be prescribed hypo-caloric diet prescription.; Dietary supplement: Dairy Protein; 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.; Behavioral: Low intensity exercise; Participants in both groups will participate in chair exercises 3 times a week.
Active Comparator: Pro-WL-LoEX; 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 Loss; Participants will be prescribed hypo-caloric diet prescription.; Dietary supplement: Dairy Protein; 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.; Behavioral: Low intensity exercise; Participants in both groups will participate in chair exercises 3 times a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Function	short physical performance battery score	baseline, 3 months, 6 months
Change in Body weight	change in weight	baseline, 3 months, 6 months
Change in lean Body Mass	BodPod	baseline, 3 months, 6 months
Change in lean Body Mass	DEXA	baseline, 3 months, 6 months
Change in fat mass	BodPod	baseline, 3 months, 6 months
Change in fat mass	DEXA	baseline, 3 months, 6 months
Change in 6-minute walk time	6-minute walk	baseline, 3 months, 6 months
Change in 8-foot up and go time	time it takes to complete 8-foot up and go	baseline, 3 months, 6 months
Change in 30 second chair stands	number of chair stands done in 30 seconds	baseline, 3 months, 6 months
Change in dietary protein intake	3-day food record	baseline, 3 months, 6 months
Change in calorie intake	3-day food record	baseline, 3 months, 6 months
Change in Bone Mineral Density	DEXA	Baseline and 6-months
Change in sleep	Pittsburgh sleep quality index	baseline, 3 months, 6 months
Change in depression	Center for Epidemiologic Studies Depression Scale	baseline, 3 months, 6 months
Change in hand grip strength	Jamar Hand Dynamometer	baseline, 3 months, 6 months
Change in physical activity	Community Health Activities Model Program for Seniors (CHAMPS)	baseline, 3 months, 6 months
Change in physical activity	Actigraph - accelerometer	Baseline, 3 months, 6 months
Change in quality of life	SF-36	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Dairy Research Institute
• Investigators: Principal Investigator: Connie Bales, PhD, RD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2015
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): October 15, 2018

Study Registration Dates

• First Submitted: May 5, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimate): May 7, 2015

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: Pro00057509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided