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Completed

NCT Number: NCT02437643

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weight Loss

Behavioral

Participants will be prescribed hypo-caloric diet prescription.

Dairy protein

Dietary 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.

Low Intensity Exercise

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Dairy Research Institute

Registry information

Acronym: DDYNAMO

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 7, 2015
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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