UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of protein supplementation at breakfast or supper for 12 weeks beyond habitual intakes on lean body mass and bone mineral density.
Title of the study (Brief title)	The effect of protein supplementation at breakfast or supper for 12 weeks beyond habitual intakes on lean body mass and bone mineral density.
Region	Japan

Condition
Condition	sarcopenia, osteoporosis
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to determine the effect of protein supplementation at breakfast and supper for 12 weeks beyond habitual intakes on lean body mass and bone mineral density in older adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The following measures would be conducted before and after 12 weeks of intervention. 1) Lean body mass and bone mineral density
Key secondary outcomes	1) bone metabolism markers 2) myokine 3) clock-gene 4) Physical functional parameter 5) physical activity(accelerometer) 6) morningness-eveningness type, the center for epidemiologic studies depression scale, pittsburgh sleep quality index (questionaire)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Breakfast (0600 - 1000): intake of milk protein 10 g/day for 12 weeks
Interventions/Control_2	Supper (1800 - 2200): intake of milk protein 10 g/day for 12 weeks
Interventions/Control_3	Breakfast placebo (0600 - 1000)
Interventions/Control_4	Supper placebo (1800 - 2200)
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	1) Above 65 years older adults 2) Gives informed consent, agrees to be randomly assigned
Key exclusion criteria	1) Impaired cardiac (e.g., with cardiac pacemaker implants), kidney functions. 2) Physically active lifestyle 3) Intake of lipid and/or glucose lowering medication 4) Intake of Antipsychotics, Hypnotic, Steroids 5) Smoking habit 6) milk allergy 7) Phenylketonuria 8) Xylocaine allergy 9) Judged ineligible by a medical doctor. 10) History or presence of osteoporosis and compression fracture 11) Individuals with acute orthopedic pain and neurological symptom 12) Obesity (BMI>35kg/m2) and sleep apnea syndrome 13) High blood pressure (SBP:above140mmHg, and DBP:above 90mmHg)
Target sample size	100

Research contact person
Name of lead principal investigator	Shigenobu Shibata
Organization	Waseda University
Division name	Faculty of Science and Engineering
Address	2-2 Wakamatsu, Shinjuku, Tokyo
TEL	03-5369-7318
Email	shibatas@waseda.jp

Public contact
Name of contact person	Hyeon-Ki Kim
Organization	Waseda University
Division name	Organization for University Research Initiatives
Address	2-2 Wakamatsu, Shinjuku, Tokyo
TEL	03-5369-7318
Homepage URL
Email	hk.kim@aoni.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Meiji Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Meiji Co., Ltd, Tokyo Women's Medical University
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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 27 Day
Anticipated trial start date	2017 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 09 Day
Last modified on	2019 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032737