Chronic Kidney Disease Requiring Chronic DialysisNCT03347773
Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity
A study testing ReGen 18% in people with Chronic Kidney Disease Requiring Chronic Dialysis and Sarcopenic Obesity, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
Chronic kidney disease patients with sarcopenic obesity are noted to have impairment in physical performance and reducing their quality of life, and the investigators also founded these patients are at higher risk of mortality. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis, Sarcopenic Obesity, Body Composition
- What is being tested?
- ReGen 18%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2017to Apr 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 40 y/o and 90 y/o
- Regular hemodialysis treatment at least 3 months
- Hemodialysis treatment thrice a week, 3.5-4.5 hours/session
- Body composition: body mass index < 28 kg/m2 and body fat percentage >25% for males or >35% for females
- The normalized protein catabolic rate (nPCR) < 1.2 g/kg/day
Who cannot join
- Inadequate Kt/V <1.2
- Active malignancy
- Liver cirrhosis
- Active infection, including tuberculosis and AIDS
- Kidney transplant less than 6 months before study enrollment
- Patients hospitalized for more than 5 days within 3 months preceding enrollment
Show all 12Show fewer
- Patients received intradialytic parental nutrition within 2 months preceding enrollment
- Inability to perform hand grip test, including patients with NG feeding or under bed-ridden status
- Patients with a cardiac pacemaker or metallic implants
- Patients are amputees
- Pregnant woman
- History of poor adherence to dialysis or medication
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Tzu Chi Hospital
New Taipei City, 231
Ting-Yun Lin, MD, 8862-6628-9779 ext. 2350, water_h2o_6@hotmail.com
Szu-chun Hung, MD, 8862-6628-9779 ext. 2350, szuchun.hung@gmail.com
About this study
Official title: Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity: a Pilot/Feasibility Randomized Controlled Trial
Chronic kidney disease patients with sarcopenic obesity are noted to have impairment in physical performance and reducing their quality of life, and the investigators also founded these patients are at higher risk of mortality. Thus, the investigators hypothesize that oral nutrition intervention could increase lean tissue mass in these patients and improve the clinical outcomes.
Read the detailed description
In chronic kidney disease (CKD) patients, disease- and age- related changes in body composition, as well as the increased prevalence of obesity, determine a combination of excess weight and reduced muscle mass or strength, recently defined as sarcopenic obesity. The prevalence of sarcopenic obesity increase with lower eGFR, and previous studies showed that up to 18.3% stage 4 CKD patients and 56% prevalent hemodialysis patient to be with sarcopenic obesity. Sarcopenic obesity was negatively correlated with physical performance and quality of life. In the investigator's previous study, nondialysis-dependent CKD patients with normal body mass index (BMI) but excess body fat had the highest risk of death compared to those with BMI above the cutoff for obesity and excess body fat during a follow up of 5 years. These patients with excess body fat but lower lean tissue mass was what so called "sarcopenic obesity" group.
Hemodialysis therapy per se has been shown to be a catabolic process. Pupim et al. showed that in eight malnourished patients undergoing hemodialysis, highly positive whole-body net protein balance during hemodialysis and improvement of skeletal muscle protein homeostasis was achieved with an intradialytic oral nutritional supplement (ONS) compared to the control, and ONS during hemodialysis resulted in persistent anabolic benefits for muscle protein metabolism in the posthemodialysis phase. In the past, randomized trials of nutritional supplement intervention in dialysis patients were focused on populations with protein energy wasting, and most studies used change in serum albumin concentration as the surrogate marker. Studies focused on dialysis patients with sarcopenic obesity are sparse. Therefore, the investigators hypothesize that ONS could improve the nutritional status among dialysis patients with sarcopenic obesity, especially increase in lean tissue, and improve clinical outcomes. This pilot/feasibility study is aimed to conduct a randomised controlled pilot trial of the feasibility of undertaking a study to assess the effect of ONS on the nutritional status of haemodialysis patients with sarcopenic obesity and will lead to a more robust definitive trial in the future.
- Being tested
- ReGen 18%
- Keywords
- Oral nutritional supplement, Sarcopenic obesity, Body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReGen 18%Dietary supplement
ReGen 18% is a kind of oral nutritional supplement, designed for patients under regular hemodialysis. One can of ReGen 18% contains 237ml, 425 Kcal, 19.1g protein, 22.7g lipid and 37.9g carbohydrate.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The subjects will be assigned to receive nutritional supplement consisting of one can of ReGen 18% (19.1 g protein, 425 Kcal) daily and standard care. Receives: Dietary Supplement: ReGen 18% |
| Control | No intervention | The subjects will be assigned to receive standard care alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lean tissue mass in kg
Measured by bioimpedance device
Measured: Measured at baseline and end of study, 4 months apart
Secondary outcomes (6)
Change in dry weight in kg
Measured by bioimpedance device
Measured: Measured at baseline and end of study, 4 months apart
Change in body mass index in kg/m^2
Measured by bioimpedance device
Measured: Measured at baseline and end of study, 4 months apart
Change in fat tissue mass in kg
Measured by bioimpedance device
Measured: Measured at baseline and end of study, 4 months apart
Change in muscle strength in kg
Handgrip test
Measured: Measured at baseline and end of study, 4 months apart
Change in albumin in mg/dl
laboratory test
Measured: Measured at baseline and end of study, 4 months apart
Change in CRP in mg/L.
laboratory test
Measured: Measured at baseline and end of study, 4 months apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Nov 2017
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting-Yun Lin, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Investigators
- Ting-Yun Lin, MD, Principal investigator, Taipei Tzu Chi Hospital, Division of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347773
- Sponsor's protocol ID
- 06-M05-079
- Status last verified
- Nov 2017
- First submitted
- 12 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma D, Hawkins M, Abramowitz MK. Association of sarcopenia with eGFR and misclassification of obesity in adults with CKD in the United States. Clin J Am Soc Nephrol. 2014 Dec 5;9(12):2079-88. doi: 10.2215/CJN.02140214. Epub 2014 Nov 12.
PubMed 25392147Gracia-Iguacel C, Qureshi AR, Avesani CM, Heimburger O, Huang X, Lindholm B, Barany P, Ortiz A, Stenvinkel P, Carrero JJ. Subclinical versus overt obesity in dialysis patients: more than meets the eye. Nephrol Dial Transplant. 2013 Nov;28 Suppl 4:iv175-81. doi: 10.1093/ndt/gft024.
PubMed 24179011Martinson M, Ikizler TA, Morrell G, Wei G, Almeida N, Marcus RL, Filipowicz R, Greene TH, Beddhu S. Associations of body size and body composition with functional ability and quality of life in hemodialysis patients. Clin J Am Soc Nephrol. 2014 Jun 6;9(6):1082-90. doi: 10.2215/CJN.09200913. Epub 2014 Apr 24.
PubMed 24763868Pupim LB, Majchrzak KM, Flakoll PJ, Ikizler TA. Intradialytic oral nutrition improves protein homeostasis in chronic hemodialysis patients with deranged nutritional status. J Am Soc Nephrol. 2006 Nov;17(11):3149-57. doi: 10.1681/ASN.2006040413. Epub 2006 Oct 4.
PubMed 17021267Kalantar-Zadeh K, Cano NJ, Budde K, Chazot C, Kovesdy CP, Mak RH, Mehrotra R, Raj DS, Sehgal AR, Stenvinkel P, Ikizler TA. Diets and enteral supplements for improving outcomes in chronic kidney disease. Nat Rev Nephrol. 2011 May 31;7(7):369-84. doi: 10.1038/nrneph.2011.60.
PubMed 21629229
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity: a Pilot/Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03347773
- Acronym / sponsor ID
- 06-M05-079
- Keywords
- Oral nutritional supplement, Sarcopenic obesity, Body composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic kidney disease patients with sarcopenic obesity are noted to have impairment in physical performance and reducing their quality of life, and the investigators also founded these patients are at higher risk of mortality. Thus, the investigators hypothesize that oral nutrition intervention could increase lean tissue mass in these patients and improve the clinical outcomes.
Detailed description
In chronic kidney disease (CKD) patients, disease- and age- related changes in body composition, as well as the increased prevalence of obesity, determine a combination of excess weight and reduced muscle mass or strength, recently defined as sarcopenic obesity. The prevalence of sarcopenic obesity increase with lower eGFR, and previous studies showed that up to 18.3% stage 4 CKD patients and 56% prevalent hemodialysis patient to be with sarcopenic obesity. Sarcopenic obesity was negatively correlated with physical performance and quality of life. In the investigator's previous study, nondialysis-dependent CKD patients with normal body mass index (BMI) but excess body fat had the highest risk of death compared to those with BMI above the cutoff for obesity and excess body fat during a follow up of 5 years. These patients with excess body fat but lower lean tissue mass was what so called "sarcopenic obesity" group.
Hemodialysis therapy per se has been shown to be a catabolic process. Pupim et al. showed that in eight malnourished patients undergoing hemodialysis, highly positive whole-body net protein balance during hemodialysis and improvement of skeletal muscle protein homeostasis was achieved with an intradialytic oral nutritional supplement (ONS) compared to the control, and ONS during hemodialysis resulted in persistent anabolic benefits for muscle protein metabolism in the posthemodialysis phase. In the past, randomized trials of nutritional supplement intervention in dialysis patients were focused on populations with protein energy wasting, and most studies used change in serum albumin concentration as the surrogate marker. Studies focused on dialysis patients with sarcopenic obesity are sparse. Therefore, the investigators hypothesize that ONS could improve the nutritional status among dialysis patients with sarcopenic obesity, especially increase in lean tissue, and improve clinical outcomes. This pilot/feasibility study is aimed to conduct a randomised controlled pilot trial of the feasibility of undertaking a study to assess the effect of ONS on the nutritional status of haemodialysis patients with sarcopenic obesity and will lead to a more robust definitive trial in the future.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: ReGen 18%The subjects will be assigned to receive nutritional supplement consisting of one can of ReGen 18% (19.1 g protein, 425 Kcal) daily and standard care. |
| Control | No intervention | –The subjects will be assigned to receive standard care alone. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 40 y/o and 90 y/o
- Regular hemodialysis treatment at least 3 months
- Hemodialysis treatment thrice a week, 3.5-4.5 hours/session
- Body composition: body mass index < 28 kg/m2 and body fat percentage >25% for males or >35% for females
- The normalized protein catabolic rate (nPCR) < 1.2 g/kg/day
Key exclusion criteria (12 listed)
- Inadequate Kt/V <1.2
- Active malignancy
- Liver cirrhosis
- Active infection, including tuberculosis and AIDS
- Kidney transplant less than 6 months before study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReGen 18%ReGen 18% is a kind of oral nutritional supplement, designed for patients under regular hemodialysis. One can of ReGen 18% contains 237ml, 425 Kcal, 19.1g protein, 22.7g lipid and 37.9g carbohydrate. | Dietary supplement | Intervention |
Primary outcome
Change in lean tissue mass in kg
Time frame: Measured at baseline and end of study, 4 months apart
Measured by bioimpedance device
6 secondary outcomes
Change in dry weight in kg
Time frame: Measured at baseline and end of study, 4 months apart
Change in body mass index in kg/m^2
Time frame: Measured at baseline and end of study, 4 months apart
Change in fat tissue mass in kg
Time frame: Measured at baseline and end of study, 4 months apart
Change in muscle strength in kg
Time frame: Measured at baseline and end of study, 4 months apart
Change in albumin in mg/dl
Time frame: Measured at baseline and end of study, 4 months apart
Change in CRP in mg/L.
Time frame: Measured at baseline and end of study, 4 months apart
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Background: PubMed 25392147Sharma D, Hawkins M, Abramowitz MK. Association of sarcopenia with eGFR and misclassification of obesity in adults with CKD in the United States. Clin J Am Soc Nephrol. 2014 Dec 5;9(12):2079-88. doi: 10.2215/CJN.02140214. Epub 2014 Nov 12.
- Background: PubMed 24179011Gracia-Iguacel C, Qureshi AR, Avesani CM, Heimburger O, Huang X, Lindholm B, Barany P, Ortiz A, Stenvinkel P, Carrero JJ. Subclinical versus overt obesity in dialysis patients: more than meets the eye. Nephrol Dial Transplant. 2013 Nov;28 Suppl 4:iv175-81. doi: 10.1093/ndt/gft024.
- Background: PubMed 24763868Martinson M, Ikizler TA, Morrell G, Wei G, Almeida N, Marcus RL, Filipowicz R, Greene TH, Beddhu S. Associations of body size and body composition with functional ability and quality of life in hemodialysis patients. Clin J Am Soc Nephrol. 2014 Jun 6;9(6):1082-90. doi: 10.2215/CJN.09200913. Epub 2014 Apr 24.
- Background: PubMed 17021267Pupim LB, Majchrzak KM, Flakoll PJ, Ikizler TA. Intradialytic oral nutrition improves protein homeostasis in chronic hemodialysis patients with deranged nutritional status. J Am Soc Nephrol. 2006 Nov;17(11):3149-57. doi: 10.1681/ASN.2006040413. Epub 2006 Oct 4.
- Background: PubMed 21629229Kalantar-Zadeh K, Cano NJ, Budde K, Chazot C, Kovesdy CP, Mak RH, Mehrotra R, Raj DS, Sehgal AR, Stenvinkel P, Ikizler TA. Diets and enteral supplements for improving outcomes in chronic kidney disease. Nat Rev Nephrol. 2011 May 31;7(7):369-84. doi: 10.1038/nrneph.2011.60.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting-Yun Lin, MD principal investigator
Taipei Tzu Chi Hospital, Division of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReGen 18% in people with Chronic Kidney Disease Requiring Chronic Dialysis and Sarcopenic Obesity, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
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 5 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: status not confirmed, as of the sponsor's last update on 20 Nov 2017. 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 Taiwan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting-Yun Lin, MD (8862-6628-9779 ext. 2350, water_h2o_6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lean tissue mass in kg (time frame: Measured at baseline and end of study, 4 months apart). 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 NCT03347773, which also lists 5 linked publications.
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 20 Nov 2017.