Influence on physical condition by "healthy meal" intake on males with high blood glucose

Influence on physical condition by "healthy meal" intake on males with high blood glucose - Influence on physical condition by "healthy meal" intake on males with high blood glucose

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000043836

Enrollment

100

Registered

2021-04-04

Start date

2021-04-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intake &quot

healthy meal&quot

for 20 days Eat usual meal

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Males aged between 30 and 64 2) Subjects who equal to or more than 5.6 % of HbA1c 3) Among the subjects who met the inclusion criteria 1) and 2), select from the subjects with high fasting blood glucose

Exclusion criteria

Exclusion criteria: 1) Subjects who are unable to continuously intake "healthy meal" during intake period 2) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and the results of preliminary examination 3) Subjects who are judged as unsuitable for the study based on the medical history 4) Subjects with food allergies 5) Subjects who have difficulty in treatment by participating in the study 6) Subjects who are receiving treatment or use equipment that affects the examination 7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 8) Subjects who have participated in other clinical study prior to the current study 9) Subjects who routinely take health foods that may affect the results 10) Subjects who regularly consume large amount of alcohol 11) Subjects who smoke excessively (more than 21 cigarettes a day) 12) Subjects with extremely irregular diet 13) Subjects with irregular life rhythms 14) Subjects who undergoes a medical examination from 2 weeks before the preliminary examination and the end of the study 15) Subjects who plan to donate blood during the study period 16) Subjects who judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

Measure	Time frame
HbA1c, fasting blood glucose at 4 week test	—

Secondary

Measure	Time frame
Blood glucose / insulin level after 75 g OGTT, each change amount, area under the concentration time curve (blood glucose / insulin AUC), blood glucose peak value (blood glucose / insulin Cmax), insulin, HOMA-IR, adiponectin, insulin, HOMA-beta at 4 week test	—

Countries

Japan

Contacts

Public ContactTakashi Nakagawa

EP Mediate Co., Ltd. Development Business Headquarters, TTC Center, Trial Planning Department

nakagawa768@eps.co.jp03-5657-4983

Outcome results