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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000081 |
Receipt No. | R000000134 |
Scientific Title | Effect of barley Intake on coronary heart disease risk factor, a randomized controlled trial. |
Date of disclosure of the study information | 2005/09/01 |
Last modified on | 2005/08/27 |
Basic information | ||
Public title | Effect of barley Intake on coronary heart disease risk factor, a randomized controlled trial. | |
Acronym | Effect of barley Intake on coronary heart disease risk factor, a randomized controlled trial. | |
Scientific Title | Effect of barley Intake on coronary heart disease risk factor, a randomized controlled trial. | |
Scientific Title:Acronym | Effect of barley Intake on coronary heart disease risk factor, a randomized controlled trial. | |
Region |
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Condition | ||
Condition | Women of aged 50 to 70 years, plasma total cholesterol of 220-280mg/dL, HbA1c of 5.5-6.5%, and without medication for hypertension, hyperlipidemia, and diabetes mellitus. | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | To assess the effect of barley intake on coronary heart disease risk factor. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Outcome measures were plasma lipids, glucose, weight, and waist. End point was variable change form baseline at 12 weeks. |
Key secondary outcomes | Comparison of mean change adjusted baseline value.
Test for interaction. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment | No need to know |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Barley group was instructed about healthy foods choice, and take barley products for 12 weeks. | |
Interventions/Control_2 | Control group was instructed about healthy foods choice. | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | women
Outpatients of human dry dock aged 50 to 70 years; total cholesterol of 220 to 280 mg/dL; hemoglobin A1c of 5.5 to 6.5%; current non-smoker; no current use of oral medication to treat hypertension, diabetes mellitus or dyslipidemia. |
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Key exclusion criteria | cardiovascular disease;
psychiatric problem; alcohol consumption >300 g/week; Usually consuming barley products. |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Interdisciplinary Graduate School of medicine and Engineering,
University of Ymanashi |
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Division name | Department of Health Sciences | ||||||
Zip code | |||||||
Address | 1110, Shimokato, Tamaho-cho, Nakakoma-gun, Yamanashi-ken Postal code 409-3898 | ||||||
TEL | 055-273-9566 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Interdisciplinary Graduate School of medicine and Engineering, University of Ymanashi | ||||||
Division name | Department of Health Sciences | ||||||
Zip code | |||||||
Address | 1110, Shimokato, Tamaho-cho, Nakakoma-gun, | ||||||
TEL | 055-273-9566 | ||||||
Homepage URL | |||||||
zenymgt@yamanashi.ac.jp |
Sponsor | |
Institute | Department of Health Sciences
Interdisciplinary Graduate School of medicine and Engineering, University of Ymanashi |
Institute | |
Department |
Funding Source | |
Organization | Hakubaku |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Yamanashi Koseiren Health Care Center.
Third Department of Internal Medicine, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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 |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000134 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |