UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A monitoring study to investigate the effects of soft meals on weight gain and grip strength in elderly volunteers
Title of the study (Brief title)	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	Hisayoshi Daito
Organization	Heishinkai Medical Group Incorporated, OCROM Clinic
Division name	Director
Address	4-12-11, Kasuga, Suita-shi, Osaka 565-0853, Japan
TEL	06-6330-8810
Email	hisayoshi.daito@heishinkai.com

Public contact
Name of contact person	Hisayoshi Daito
Organization	Heishinkai Medical Group Incorporated, OCROM Clinic
Division name	Director
Address	4-12-11, Kasuga, Suita-shi, Osaka 565-0853, Japan
TEL	06-6330-8810
Homepage URL
Email	hisayoshi.daito@heishinkai.com

Sponsor
Institute	InCROM Inc
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034122