Tokyo, July 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062143) titled 'A Study to Verify the Additional Weight Loss Effect of Consuming Test Foods in Specific Health Guidance' on July 6.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - NISSIN FOOD PRODUCTS CO., LTD.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study targets men who are eligible for active guidance under the Specific Health Guidance program designated by the Ministry of Health, Labour and Welfare. The objective is to verify the additional benefits of consuming the test food within the context of Specific Health Guidance by providing study participants in the test food intake group with information regarding Specific Health Guidance and the test food, and having them replace one of their daily meals (breakfast, lunch, or dinner) with the test food.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - 1) Guidance equivalent to specific health guidance
2) Information
3) Oral intake of the test food (replacing one meal-breakfast, lunch, or dinner-with the test food for 12 weeks)
Interventions/Control_2 - 1) Guidance equivalent to specific health guidance
Eligibility:
Age-lower limit - 40
years-old
Gender - Male
Key inclusion criteria - [1] Men aged 40 to 64 at the time of obtaining consent
[2] Individuals who are the subject of the Specific Health Guidance designated by the Ministry of Health Labour and Welfare (a subject of an active support).
(Criteria)
Meet the criterion 1 and at least 2 items from criterion 3, or meet the criterion 2 and at least 3 items from criterion 3.
1) Abdominal circumference: over 85 cm.
2) BMI: over 25 kg/m2.
3)Additional conditions:
- A smoker.
- Blood glucose:
fasting blood glucose: over 100 mg/dl or HbA1c: over 5.6%.
- Lipids:
Triglycerides: over 150 mg/dl or HDL-Cho: less than 40 mg/dl
- Blood pressure:
systolic blood pressure: over 130 mmHg and/or diastolic blood pressure: 85 mmHg.
[3]Individuals whose written informed consent has been obtained.
[4]Individuals who can visit an inspection facility and be inspected in designated days.
[5]Individuals judged appropriate for the study by the principal.
Key exclusion criteria - Individuals
[1] currently suffering from any medical condition and undergoing drug treatment.
[2] with a history of serious disorders or current conditions affecting the digestive system, liver, kidneys, heart, lungs, blood, or mental health.
[3] who have taken medication for the treatment of a medical condition within the past month.
[4] with symptoms of drug or food allergies.
[5] who have donated whole blood or plasma in amounts exceeding 200 mL within the past month or 400 mL within the past three months.
[6] who are currently receiving specific health guidance, or who have received such guidance within the past six months prior to the pre-intervention examination; or individuals who are likely to receive specific health guidance during the study period.
[7] with irregular eating habits and a tendency toward picky eating.
[8] whose daily alcohol consumption exceeds 60 g of pure alcohol per day.
[9] who currently, or within the past three months, regularly consume FOSHU, FFC, or other health foods claimed to improve lipid/glucose metabolism, blood pressure, visceral fat, or body fat; or who plan to consume such products during the study period.
[10] who may change their lifestyle habits during the study period.
[11] who would find it difficult to consume the test food by substituting it for one of their meals (breakfast, lunch, or dinner) during the trial period.
[12] who are unable to properly store or consume the test food due to reasons such as the inability to install a freezer or the lack of a microwave oven.
[13] currently participating in another human clinical trial, or individuals for whom less than three months have elapsed since their participation in another human clinical trial.
[14] who themselves or their families work at companies or research institutions that develop, manufacture, or sell health and functional foods.
[15] judged inappropriate for the study by the principal.
Target Size - 300
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 09 Day
Date of IRB - 2026 Year 06 Month 11 Day
Anticipated trial start date - 2026 Year 08 Month 01 Day
Last follow-up date - 2026 Year 11 Month 22 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070847
Disclaimer: Curated by HT Syndication.
