Usefulness of Balanced High Protein Supplementation on Recovery and Clinical Outcomes After Chemotherapy
NCT ID: NCT05938504
Last Updated: 2023-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
154 participants
INTERVENTIONAL
2023-03-14
2025-02-28
Brief Summary
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Participants will intake test or placebo oral nutritional supplements. Researchers will compare test groups and placebo groups to see if test oral supplements are more useful in muscle function recovery and clinical outcomes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Control group
Subjects will receive two packs of placebo ONS (ONS\_320275) orally daily
ONS_320275
Subjects will consume two packs (165ml/pack) of placebo ONS (ONS\_320275) orally daily at any time of day.
Test group
Subjects will receive two packs of test ONS (ONS\_211567) orally daily
ONS_211567
Subjects will consume two packs (165ml/pack) of test ONS (ONS\_211567) orally daily at any time of day.
Interventions
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ONS_320275
Subjects will consume two packs (165ml/pack) of placebo ONS (ONS\_320275) orally daily at any time of day.
ONS_211567
Subjects will consume two packs (165ml/pack) of test ONS (ONS\_211567) orally daily at any time of day.
Eligibility Criteria
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Inclusion Criteria
* A person who is diagnosed with direct colorectal cancer and begins chemotherapy
* A person who voluntarily agreed to participate in this trial and signed a informed consent form
Exclusion Criteria
* A person with a BMI of 30.0 kg/m2 or more
* A person who is diabetes mellitus with whose blood sugar is not controlled even when taking medication
* More than 126mg/dL of fasting blood sugar even on diabetes medication
* A person diagnosed with hypertension whose blood pressure is not controlled even when taking medication
* Systolic blood pressure 160mmHg or diastolic blood pressure 100mmHg or higher even when taking hypertension medication
* A person with renal dysfunction (up 1.5 times the upper limit of Creatinine normal) and liver dysfunction (up 2.5 times the upper limit of AST and ALT normal)
* A person with a serious musculoskeletal problem
* A person who has been diagnosed with acute or serious diseases (e.g., liver, kidney, heart, thyroid disease, etc.) or is on medication
* A person who has continuously taken health functional foods related to the ability to perform exercise within three months before visiting (Hormones, muscle enhancers, protein supplementation and muscle function improvement)
* A person who is allergic or overreacting to the ingredients of a test product
* All ingredients of the test product shall be specified in the consent form, and all ingredients that may cause allergies, such as sodium casein, shall be checked during screening
* A person who has participated in another clinical trial or a drug clinical trial within one month of the commencement of this test
* A person who is illiterate or whose ability is limited
* A person who is pregnant or lactating
* A person judged inappropriate by a researcher to participate in this study for other reasons
19 Years
ALL
No
Sponsors
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Nutriworks
INDUSTRY
Daesang Wellife
INDUSTRY
Responsible Party
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Locations
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Seoul St. Mary's hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PROFIT
Identifier Type: -
Identifier Source: org_study_id
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