JRCT ID: jRCTs061260021
Registered date:28/05/2026
A comparative study on the effects of the rare sugar D-allulose in patients with obesity.
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Obesity disease |
| Date of first enrollment | 28/05/2026 |
| Target sample size | 30 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Outpatients diagnosed with obesity disease will undergo standard nutritional counseling and additionally ingest D-allulose with meals for a duration of 16 weeks. The dosage of D-allulose will be 5 g per meal, totaling 15 g per day. |
Outcome(s)
| Primary Outcome | Body fat percentage will be assessed and compared using the InBody body composition analyzer. |
|---|---|
| Secondary Outcome | Changes in body fat mass, body weight, body mass index (BMI), abdominal subcutaneous fat area, and blood biomarkers Changes in various clinical laboratory parameters Assessment of sleep quality Measurement of physical activity levels Assessment of the gut microbiota Evaluation of changes in oral health status |
Key inclusion & exclusion criteria
| Age minimum | >= 20age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | Participants aged 20 years or older at the time of informed consent. Patients with obesity who are receiving outpatient care at our institution and have a body mass index (BMI) of 27 kg/m2 at the time of screening. Patients who are able to provide written informed consent to participate in this study. |
| Exclude criteria | Patients who are currently receiving GLP1 receptor agonists or GLP1 GIP dual receptor agonists. Patients with a history of serious adverse reactions to D allulose. Pregnant women, postpartum women, breastfeeding women, or women who may be pregnant. Patients with severe renal impairment (estimated glomerular filtration rate eGFR 15). Patients with other serious comorbid conditions. Patients who, in the opinion of the principal investigator or sub investigators, are deemed inappropriate for participation because study participation would not be in the subject s best interest , or because participation could interfere with, restrict, or confound evaluations specific to this clinical study protocol. Employees of the principal investigator, sub investigators, or the study site who are directly involved in the conduct of this study or other clinical studies, as well as their family members. |
Related Information
| Primary Sponsor | Fukunaga Kensaku |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Kensaku Fukunaga |
| Address | 1750-1,Miki-cho, Kita-gun Kagawa Japan 761-0793 |
| Telephone | +81-878912230 |
| fukunaga.kensaku@kagawa-u.ac.jp | |
| Affiliation | Kagawa University Hospital |
| Scientific contact | |
| Name | Kensaku Fukunaga |
| Address | 1750-1,Miki-cho, Kita-gun Kagawa Japan 761-0793 |
| Telephone | +81-878912230 |
| fukunaga.kensaku@kagawa-u.ac.jp | |
| Affiliation | Kagawa University Hospital |