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Exercise and Nutrition for Healthy AgeiNg (ENHANce)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649698
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : March 26, 2020
Sponsor:
Collaborators:
KU Leuven
VISTA-Life
Nestlé Health Science Belgium
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
The aim of this randomized placebo-controlled 5-arm clinical trial is to evaluate the effect of combined anabolic interventions compared to single or placebo interventions on physical performance in community-dwelling (pre)sarcopenic elderly (≥ 65 years) and to determine the underlying mechanisms of action. Important secondary outcome measures are muscle mass, muscle strength, compliance to the interventions (exercise program, protein and omega-3 supplementation) and functional, cognitive and nutritional status.

Condition or disease Intervention/treatment Phase
Sarcopenia Behavioral: Home-based training program Dietary Supplement: High-quality protein supplement Dietary Supplement: Omega-3 fatty acid Drug: Placebo protein powder Drug: Placebo omega-3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
  • Participant: Yes blinded for protein and omega-3
  • Investigator: Yes blinded for protein and omega-3
  • Outcomes Assessor: Yes blinded for protein and omega-3
  • No blinding for exercise intervention.
  • Statisticus is blinded for protein, omega-3 and exercise intervention.
Primary Purpose: Treatment
Official Title: Exercise and Nutrition for Healthy AgeiNg: Anabolic Interventions for Older People With (Pre)Sarcopenia to Improve Physical Functioning, Muscle Mass and Muscle Strength and to Understand the Underlying Mechanisms of Action.
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home-based training program
Home-based training program + protein placebo + omega-3 placebo
Behavioral: Home-based training program
Exercise intervention: During the intervention period, the participant will perform the optimized and personally adapted Otago Exercise Program (OEP). The participant is encouraged to perform the resistance exercises three times a week with a rest day in between. The participant is advised to perform the exercises in close temporal proximity to one of the moments of the intake of the protein supplement. The participant will also follow a walking plan in which he or she needs to walk 30 minutes twice a week. These 30 minutes can be broken down to three 10-minute walks throughout the day. During the follow-up period, participants may continue the OEP, but no personal encouragement will be given during this period.

Drug: Placebo protein powder
Isocaloric maltodextrin powder. Amount based on food diary.

Drug: Placebo omega-3
Peanut oil soft gel capsules. 1g/ capsule. 1 capsule/day

Experimental: High-quality protein supplement
High-quality protein supplement + omega-3 placebo
Dietary Supplement: High-quality protein supplement
The participant will receive an individually adapted protein supplement to achieve the recommend total (usual diet and supplements) daily intake of 1.5 g/protein/kg for frail elderly. This will be realized by adding an individualized amount (g) of protein powder during breakfast, lunch, dinner or snack between meals, or before breakfast or after dinner, based on the subjects' food intake assessed by a food diary. The participant will take the protein supplement from 5 days before the start of the intervention. The protein powder is commercially available and consists of 4.5g protein/5g powder. During the follow-up, no protein supplement is added.

Drug: Placebo omega-3
Peanut oil soft gel capsules. 1g/ capsule. 1 capsule/day

Experimental: 2 Anabolic interventions
Home-based training program and high quality protein supplement
Behavioral: Home-based training program
Exercise intervention: During the intervention period, the participant will perform the optimized and personally adapted Otago Exercise Program (OEP). The participant is encouraged to perform the resistance exercises three times a week with a rest day in between. The participant is advised to perform the exercises in close temporal proximity to one of the moments of the intake of the protein supplement. The participant will also follow a walking plan in which he or she needs to walk 30 minutes twice a week. These 30 minutes can be broken down to three 10-minute walks throughout the day. During the follow-up period, participants may continue the OEP, but no personal encouragement will be given during this period.

Dietary Supplement: High-quality protein supplement
The participant will receive an individually adapted protein supplement to achieve the recommend total (usual diet and supplements) daily intake of 1.5 g/protein/kg for frail elderly. This will be realized by adding an individualized amount (g) of protein powder during breakfast, lunch, dinner or snack between meals, or before breakfast or after dinner, based on the subjects' food intake assessed by a food diary. The participant will take the protein supplement from 5 days before the start of the intervention. The protein powder is commercially available and consists of 4.5g protein/5g powder. During the follow-up, no protein supplement is added.

Drug: Placebo omega-3
Peanut oil soft gel capsules. 1g/ capsule. 1 capsule/day

Experimental: 3 Anabolic interventions
Home-based training program, high-quality protein supplement and omega-3 fatty acids
Behavioral: Home-based training program
Exercise intervention: During the intervention period, the participant will perform the optimized and personally adapted Otago Exercise Program (OEP). The participant is encouraged to perform the resistance exercises three times a week with a rest day in between. The participant is advised to perform the exercises in close temporal proximity to one of the moments of the intake of the protein supplement. The participant will also follow a walking plan in which he or she needs to walk 30 minutes twice a week. These 30 minutes can be broken down to three 10-minute walks throughout the day. During the follow-up period, participants may continue the OEP, but no personal encouragement will be given during this period.

Dietary Supplement: High-quality protein supplement
The participant will receive an individually adapted protein supplement to achieve the recommend total (usual diet and supplements) daily intake of 1.5 g/protein/kg for frail elderly. This will be realized by adding an individualized amount (g) of protein powder during breakfast, lunch, dinner or snack between meals, or before breakfast or after dinner, based on the subjects' food intake assessed by a food diary. The participant will take the protein supplement from 5 days before the start of the intervention. The protein powder is commercially available and consists of 4.5g protein/5g powder. During the follow-up, no protein supplement is added.

Dietary Supplement: Omega-3 fatty acid
Four weeks before the start of the intervention, the participant will start the intake of 1 omega-3 capsule providing in total 500 mg EPA and 450 mg DHA until the end of the intervention. He or she has to take the supplement once daily at a chosen time. During the follow-up, no omega-3 supplement will be given.

Placebo Comparator: Placebo protein powder and omega-3
Control group: protein placebo + omega-3 placebo
Drug: Placebo protein powder
Isocaloric maltodextrin powder. Amount based on food diary.

Drug: Placebo omega-3
Peanut oil soft gel capsules. 1g/ capsule. 1 capsule/day




Primary Outcome Measures :
  1. Change in physical functioning [ Time Frame: Measured at baseline, week 12 and week 24. ]
    Change in SPPB score

  2. Percentage of participants with change in physical functioning [ Time Frame: Measured at baseline, week 12 and week 24. ]
    the percentage of participants with more than 1 or 1 point increase in SPPB score.


Secondary Outcome Measures :
  1. Change in muscle mass (after intervention-baseline) [ Time Frame: Measured at screening, week 12 and week 24 with DXA or when screening is 6 weeks prior to baseline, DXA will also be performed at baseline. At screening, baseline, week 12 and week 24 with BIA. ]
    Appendicular lean mass will be measured with a whole-body DXA scan and by BIA.

  2. Change in muscle strength (after intervention-baseline) [ Time Frame: Hand grip measured at screening, baseline, week 12 and week 24. Biodex measured at baseline, week 12 and week 24. ]
    Muscle strength of the knee-extensor, knee-flexor and hip abductors will be measured by Biodex and hand grip strength with dynamometer.

  3. Compliance to the exercise intervention, subjective [ Time Frame: baseline untill week 12 ]

    Compliance to the Otago program will be assessed by measure of:

    - The number of Otago sessions the participant performed divided by the number of Otago sessions the participants needed to perform. Likewise, this will be calculated for the walking program and for the integral exercise intervention.


  4. Compliance to the exercise intervention, objective [ Time Frame: baseline untill week 12 ]

    Compliance to the Otago program will be assessed by measure of:

    - Monitor and diary: Length of exercise session (time). Pattern recognition of exercise groups by algorithm development


  5. Compliance to the exercise intervention, subjective, detailed [ Time Frame: baseline untill week 12 ]

    Compliance to the Otago program will be assessed by measure of:

    - Diary: the reported intensity of the strength exercises


  6. Compliance to the protein supplementation, objective [ Time Frame: Urine samples at baseline, week 1, 2, 4, 6, 8, 10, 12, 24. ]

    Compliance to protein supplementation:

    - The number of nutritional intakes the participant did divided by the number of intakes of nutritional supplement the participant was prescribed.


  7. Compliance to the protein supplementation, subjective [ Time Frame: Urine samples at baseline, week 1, 2, 4, 6, 8, 10, 12, 24. ]

    Compliance to protein supplementation:

    - Count and weight returned powder boxes


  8. Compliance to the protein supplementation objective [ Time Frame: Urine samples at baseline, week 1, 2, 4, 6, 8, 10, 12, 24. ]

    Compliance to protein supplementation:

    - N content in 8 24h urine samples by the Dumas method (28) to estimate rise in protein intake and Creatinine index to estimate the completion of the urine samples (29, 30)


  9. Compliance to the omega-3 supplementation, subjective [ Time Frame: baseline, week 12 and week 24. ]

    Compliance to omega-3 supplement

    - Count returned capsules and placebo tablets


  10. Compliance to the omega-3 supplementation, objective [ Time Frame: baseline, week 12 and week 24. ]

    Compliance to omega-3 supplement

    - Compliance to the omega- 3 supplement is assessed by counting the number of capsules during each study visit and by analysis of RBC membrane fatty acid profile


  11. Functional status: fraitly [ Time Frame: baseline, week 12 and 24 ]
    - Change in physical frailty stage defined by Fried et al (frail (3-5/5), prefrail (1-2/5), robust (0/5))

  12. Functional status: activities of daily living [ Time Frame: baseline, week 12 and 24 ]
    Change in ADL (Barthel-index)

  13. Functional status: balance [ Time Frame: baseline, week 12 and 24 ]
    Change in balance (Mini-BESTest)

  14. Functional status: change in physical activity [ Time Frame: baseline, week 12 and 24 ]
    Change in PA by the MoveMonitor+ (MM+) (method under development in our research group)

  15. Functional status: health-related quality of life [ Time Frame: baseline, week 12 and 24 ]
    - Change in health-related quality of life, according to SF-36 questionnaire

  16. Functional status: falls [ Time Frame: baseline, week 12 and 24 ]
    - Number of falls and the circumstances, identified using weekly fall calendars + FES-I

  17. Cognitive status: immediate and delayed memory, attention, language and visuospatial skills [ Time Frame: baseline, week 12 and 24 ]
    - The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): immediate and delayed memory, attention, language and visuospatial skills;

  18. Cognitive status: inhibition [ Time Frame: baseline, week 12 and 24 ]
    Stroop test (inhibition)

  19. Cognitive status [ Time Frame: baseline, week 12 and 24 ]
    - Maze test

  20. Nutritional status: malnutrition [ Time Frame: at baseline (preparation for food diary), week 6, week 12 and week 24 ]
    - Changes in numbers of participants with malnutrition, according to Mini Nutritional Assessment (MNA).

  21. Nutritional status: nutriënt intake [ Time Frame: at baseline (preparation for food diary), week 6, week 12 and week 24 ]
    - Changes in nutriënt intake, according to the four day food diary.

  22. Patient reported benefits and adverse effects [ Time Frame: week 1, 4, 8, 12, 16, 20, 22, 24. ]
    Benefits and adverse effects are asked. Participants will describe their thoughts about the study, what they like and don't like.

  23. Change in CRP [ Time Frame: baseline, week 1, 4, 12 and 24 ]
    change in hs-CRP

  24. Change in hemoglobin [ Time Frame: baseline, week 12 and week 24 ]
    Change in hemoglobin

  25. Change in creatinine [ Time Frame: baseline, week 12 and week 24 ]
    Change in creatinine

  26. Change in ureum [ Time Frame: baseline, week 12 and week 24 ]
    Change in ureum

  27. Change in serum albumin [ Time Frame: baseline, week 12 and week 24 ]
    Change in serum albumin

  28. Change in glucose [ Time Frame: baseline, week 12 and week 24 ]
    Change in glucose

  29. Change in cholesterol (HDL, LDL, total, Triglycerides) [ Time Frame: baseline, week 12 and week 24 ]
    Change in cholesterol (HDL, LDL, total, Triglycerides)

  30. Change in insulin [ Time Frame: baseline, week 12 and week 24 ]
    Change in insulin

  31. Change in IGF-1 [ Time Frame: baseline, week 12 and week 24 ]
    Change in IGF-1

  32. Change in 25-hydroxy-vitamin D [ Time Frame: baseline, week 12 and week 24 ]
    Change in 25-hydroxy-vitamin D

  33. Change in creatinine kinase [ Time Frame: baseline, week 12 and week 24 ]
    Change in creatinine kinase

  34. Change in indoxyl sulfate [ Time Frame: baseline, week 12 and week 24 ]
    Change in indoxyl sulfate

  35. Change in IL-6 [ Time Frame: baseline, week 12 and week 24 ]
    Change in IL-6

  36. Change in IL-1b [ Time Frame: baseline, week 12 and week 24 ]
    Change in IL-1b

  37. Change in TNF-alpha [ Time Frame: baseline, week 12 and week 24 ]
    Change in TNF-alpha

  38. Change in myostatin [ Time Frame: baseline, week 12 and week 24 ]
    Change in myostatin

  39. Change in activin A [ Time Frame: baseline, week 12 and week 24 ]
    Change in activin A



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female persons with (pre)sarcopenia according to the European Working Group on Sarcopenia in Older People (EWGSOP): reduced muscle mass without (presarcopenia) or with (sarcopenia) reduced walking speed (≤ 0.8m/s) or muscle strength OR probable, confirmed or severe sarcopenia according to EWGSOP2.
  2. 65 years or older;
  3. Community-dwelling elderly or assisted living;
  4. In case of one or more positive answer(s) on the health screen for exercise, subjects need approval of their general practitioner to participate in this RCT.

    • Uncontrolled or unstable health problems
    • Uncontrolled pain or feeling unwell the day of the exercise
    • Recently diagnosed cardiovascular events
    • SBP ≥ 180mmHg and/or DBP ≥ 100 mmHg
    • Resting tachycardia > 100 bpm
    • Uncontrolled atrial or ventricular arrhythmias
    • Unstable or acute heart failure
    • Lasting, increased pain following a previous session
    • Suspected acute injury
    • Recent injurious fall without medical assessment
    • Severe breathlessness or dizziness
    • Uncontrolled pulmonary problems
    • Rheumatoid arthritis flare up or acute systemic illness/infection
    • Unexplained lethargy

Exclusion Criteria:

  1. Impairments/diseases that impose problems to participation in the study;
  2. Allergy to milk or soy or peanut;
  3. MMSE < 21;
  4. Terminal illness (prognosis < 6 months);
  5. Persons who followed a physical training program in the last 6 months (twice or more/week);
  6. Persons with a daily intake of > 1.5 g protein/kg BW/day;
  7. Diagnosis of severe kidney disease (GFR < 30 ml/min) or diabetes mellitus;
  8. Unable to communicate in Dutch, English or French.

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): NCT03649698


Contacts
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Contact: Lenore Dedeyne, MSc +32 16 34 01 35 lenore.dedeyne@kuleuven.be
Contact: Jolan Dupont jolan.dupont@uzleuven.be

Locations
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Belgium
Gerontology and Geriatrics, Department of chronic diseases, metabolism and ageing (CHROMETA) KU Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Lenore Dedeyne, MSc    +32 16 34 01 35    Lenore.dedeyne@kuleuven.be   
Principal Investigator: Evelien Gielen, Prof MD PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
VISTA-Life
Nestlé Health Science Belgium
Investigators
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Principal Investigator: Evelien Gielen, Prof MD PhD Gerontology and Geriatrics, Department of Public Health and primary care KU Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03649698    
Other Study ID Numbers: S60763
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Sarcopenia
Nutrition
Protein
Vitamin D
Exercise
Older people
Frailty
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms