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DynapeniaDDYNAMONCT02437643

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

A study testing Weight Loss, Dairy Protein and Low intensity exercise in people with Dynapenia and Obesity, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Dynapenia, Obesity
What is being tested?
Weight Loss, Dairy Protein and Low intensity exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
1 siteUnited States
Study dates
17 Aug 2015to 15 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

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.

Read the 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.
Conditions
Dynapenia, Obesity
Being tested
Weight Loss, Dairy Protein, Low intensity exercise
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight LossBehavioural

    Participants will be prescribed hypo-caloric diet prescription.

  • 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.

  • Low intensity exerciseBehavioural

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

Study groups in NCT02437643
Study groupRoleWhat they receive
WL-LoEXPlacebo comparator10% Weight loss diet plus low intensity exercise (protein ~0.8g/kg). Participants will be provided one serving of dairy protein daily.
Receives: Behavioral: Weight Loss; Dietary Supplement: Dairy Protein; Behavioral: Low intensity exercise
Pro-WL-LoEXActive comparatorProtein-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.
Receives: Behavioral: Weight Loss; Dietary Supplement: Dairy Protein; Behavioral: Low intensity exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline, 3 months, 6 months

  2. Change in muscle adipose infiltration

    CT-scan

    Measured: baseline, 3 months, 6 months

Secondary outcomes (18)

  1. Change in Physical Function

    short physical performance battery score

    Measured: baseline, 3 months, 6 months

  2. Change in Body weight

    change in weight

    Measured: baseline, 3 months, 6 months

  3. Change in lean Body Mass

    BodPod

    Measured: baseline, 3 months, 6 months

  4. Change in lean Body Mass

    DEXA

    Measured: baseline, 3 months, 6 months

  5. Change in fat mass

    BodPod

    Measured: baseline, 3 months, 6 months

  6. Change in fat mass

    DEXA

    Measured: baseline, 3 months, 6 months

  7. Change in 6-minute walk time

    6-minute walk

    Measured: baseline, 3 months, 6 months

  8. Change in 8-foot up and go time

    time it takes to complete 8-foot up and go

    Measured: baseline, 3 months, 6 months

  9. Change in 30 second chair stands

    number of chair stands done in 30 seconds

    Measured: baseline, 3 months, 6 months

  10. Change in dietary protein intake

    3-day food record

    Measured: baseline, 3 months, 6 months

  11. Change in calorie intake

    3-day food record

    Measured: baseline, 3 months, 6 months

  12. Change in Bone Mineral Density

    DEXA

    Measured: Baseline and 6-months

  13. Change in sleep

    Pittsburgh sleep quality index

    Measured: baseline, 3 months, 6 months

  14. Change in depression

    Center for Epidemiologic Studies Depression Scale

    Measured: baseline, 3 months, 6 months

  15. Change in hand grip strength

    Jamar Hand Dynamometer

    Measured: baseline, 3 months, 6 months

  16. Change in physical activity

    Community Health Activities Model Program for Seniors (CHAMPS)

    Measured: baseline, 3 months, 6 months

  17. Change in physical activity

    Actigraph - accelerometer

    Measured: Baseline, 3 months, 6 months

  18. Change in quality of life

    SF-36

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2015 (estimated)
  2. Study start17 Aug 2015
  3. Primary completion15 Oct 2018
  4. Study completion15 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02437643
Sponsor's protocol ID
Pro00057509
Acronym
DDYNAMO
Status last verified
Nov 2018
First submitted
5 May 2015
Last updated
7 Nov 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

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.

    PubMed 33719918

Questions about this trial

What is this clinical trial studying?

A study testing Weight Loss, Dairy Protein and Low intensity exercise in people with Dynapenia and Obesity, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in muscle quality (time frame: baseline, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02437643, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.

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