UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029873 |
|---|---|
| Receipt number | R000034122 |
| Scientific Title | A monitoring study to investigate the effects of soft meals on weight gain and grip strength in elderly volunteers |
| Date of disclosure of the study information | 2017/11/10 |
| Last modified on | 2018/04/05 17:09:24 |
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Basic information
Public title
A monitoring study to investigate the effects of soft meals on weight gain and grip strength in elderly volunteers
Acronym
Effects of soft meals on improving undernutrition in elderly volunteers
Scientific Title
A monitoring study to investigate the effects of soft meals on weight gain and grip strength in elderly volunteers
Scientific Title:Acronym
Effects of soft meals on improving undernutrition in elderly volunteers
Region
| Japan |
Condition
Condition
Elderly individuals aged 65 years old or older
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes in body weight, BMI, grip strength and clinical laboratory tests when elderly volunteers eat test diets at home for 21 days which are physically soft to reduce the need to chew
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in body weight, BMI, grip strength, serum total protein and albumin from baseline (before start of test diets) to end of test diets
Key secondary outcomes
Changes over time in body weight, BMI, grip strength, vital signs and clinical laboratory tests
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The test diets are easy to chew and swallow without effort for those who have a little difficulty in chewing hard foods or a large chunk of foods. Examples of soft meals are softly cooked rice, braised pork belly, grilled fish, thick omelet, stewed carrot, donut and jelly. The maximum hardness will be 500000 N/m2, and the approximate daily calorie will be 2100 kcal for males and 1650 kcal for females. Subjects will consume the test diets 4 times a day, i.e., breakfast, lunch, snack and dinner for 21 days.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly males and females who voluntarily give written informed consent; who are 65 years or older; whose BMI is < 21.0; who have a difficulty in chewing hard meals but have no problems in appetite or swallowing function; who are capable of undergoing specified examinations; and who are capable of recording test diet intake and answering questionnaire.
Key exclusion criteria
Diabetic patients
History of previous or present illness that interferes with ethical conduct of the research as determined by the investigator, e.g., hepatic or renal disorder; gastrointestinal, cardiovascular, respiratory, endocrine, metabolic, nervous, or psychological disease
Those with extremely lowered appetite
Those who possibly have allergy to test diets
History of previous or present drug or alcohol dependence
Those who live in a welfare facility
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisayoshi Daito |
Organization
Heishinkai Medical Group Incorporated, OCROM Clinic
Division name
Director
Zip code
Address
4-12-11, Kasuga, Suita-shi, Osaka 565-0853, Japan
TEL
06-6330-8810
hisayoshi.daito@heishinkai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisayoshi Daito |
Organization
Heishinkai Medical Group Incorporated, OCROM Clinic
Division name
Director
Zip code
Address
4-12-11, Kasuga, Suita-shi, Osaka 565-0853, Japan
TEL
06-6330-8810
Homepage URL
hisayoshi.daito@heishinkai.com
Sponsor or person
Institute
InCROM Inc
Institute
Department
Personal name
Funding Source
Organization
Partnership Support Project for Enhancement of Commercial and Service Competitiveness 2017 (New Partnership Support Program)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
InCROM Inc.
InCROM Plus Inc.
Kindai University Faculty of Agriculture, Food Science and Nutrition
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人 平心会 OCROMクリニック（大阪府）/Heishinkai Medical Group Incorporated, OCROM Clinic (Osaka, Japan)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Among 30 subjects, a total of 28 finished the trial, The change in body weight from the start of the study to the end was -0.45 +/- 0.75 kg (Mean+/-SD, the same hereinafter), 95% confidence interval (CI) on both sides was [-0.74, -0.15], P=0.0041, showing a significant decrease. Through the analysis of the individual weight change, body weight increased in only 6 subjects, equaled in 3 subjects, and decreased in 19 subjects. More than 1 kg of body weight decreased in 6 subjects, whereas that increased in none. The maximum change in body weight was 0.8 kg, and minimum -2.7 kg.
The change in BMI was -0.12 +/- 0.30, and the 95% CI on both sides was [-0.24, -0.01], P=0.0384, showing a significant decrease. No significant changes in grip strength, serum total protein, or albumin were observed. The change in grip strength was 0.1 +/- 1.6 kg, and 95% CI on both sides was [-0.5, 0.8], P=0.6458. The change in serum total protein was -0.07 +/- 0.27 g/dL, 95% CI on both sides was [-0.17, 0.04], P=0.1872. The change in albumin was -0.02 +/- 0.18 g/dL, 95% CI on both sides was [-0.09, 0.05], P=0.6131. No significant adverse events were observed.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 07 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 08 | Day |
Last modified on
| 2018 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034122
