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

Obesity Clinical Trial

— DDYNAMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437643
• Other study ID #: Pro00057509
• Status: Completed
• Phase: N/A
• Start date: August 17, 2015
• Est. completion date: October 15, 2018

Study information

• Verified date: November 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 15, 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dynapenia
• Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Dairy Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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