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

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ClinicalTrials.gov Identifier: NCT02437643
Recruitment Status : Completed
First Posted : May 7, 2015
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Dairy Research Institute
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Dynapenia Obesity Behavioral: Weight Loss Dietary Supplement: Dairy Protein Behavioral: Low intensity exercise Not Applicable

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  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Enhanced Protein (Dairy) Weight Loss Intervention for Dynapenic Obesity: Impact on Muscle Quality and Composition
Actual Study Start Date : August 17, 2015
Actual Primary Completion Date : October 15, 2018
Actual Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in muscle quality [ Time Frame: baseline, 3 months, 6 months ]
    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

  2. Change in muscle adipose infiltration [ Time Frame: baseline, 3 months, 6 months ]
    CT-scan


Secondary Outcome Measures :
  1. Change in Physical Function [ Time Frame: baseline, 3 months, 6 months ]
    short physical performance battery score

  2. Change in Body weight [ Time Frame: baseline, 3 months, 6 months ]
    change in weight

  3. Change in lean Body Mass [ Time Frame: baseline, 3 months, 6 months ]
    BodPod

  4. Change in lean Body Mass [ Time Frame: baseline, 3 months, 6 months ]
    DEXA

  5. Change in fat mass [ Time Frame: baseline, 3 months, 6 months ]
    BodPod

  6. Change in fat mass [ Time Frame: baseline, 3 months, 6 months ]
    DEXA

  7. Change in 6-minute walk time [ Time Frame: baseline, 3 months, 6 months ]
    6-minute walk

  8. Change in 8-foot up and go time [ Time Frame: baseline, 3 months, 6 months ]
    time it takes to complete 8-foot up and go

  9. Change in 30 second chair stands [ Time Frame: baseline, 3 months, 6 months ]
    number of chair stands done in 30 seconds

  10. Change in dietary protein intake [ Time Frame: baseline, 3 months, 6 months ]
    3-day food record

  11. Change in calorie intake [ Time Frame: baseline, 3 months, 6 months ]
    3-day food record

  12. Change in Bone Mineral Density [ Time Frame: Baseline and 6-months ]
    DEXA

  13. Change in sleep [ Time Frame: baseline, 3 months, 6 months ]
    Pittsburgh sleep quality index

  14. Change in depression [ Time Frame: baseline, 3 months, 6 months ]
    Center for Epidemiologic Studies Depression Scale

  15. Change in hand grip strength [ Time Frame: baseline, 3 months, 6 months ]
    Jamar Hand Dynamometer

  16. Change in physical activity [ Time Frame: baseline, 3 months, 6 months ]
    Community Health Activities Model Program for Seniors (CHAMPS)

  17. Change in physical activity [ Time Frame: Baseline, 3 months, 6 months ]
    Actigraph - accelerometer

  18. Change in quality of life [ Time Frame: Baseline, 3 months, 6 months ]
    SF-36



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437643


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Dairy Research Institute
Investigators
Principal Investigator: Connie Bales, PhD, RD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02437643     History of Changes
Other Study ID Numbers: Pro00057509
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes