Clinical Study on Induction of Beige Adipocytes by the Rare Sugar D-Allulose

JRCT ID: jRCTs061240080

Registered date:08/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Adults
• Date of first enrollment: 08/11/2024
• Target sample size: 5
• Study type: Interventional
• Intervention(s): D-Allulose 5 g with each meal (15 g/day) for 8 weeks

Outcome(s)

• Primary Outcome: FDG-PET will be taken before and after feeding 5 g (15 g/day) of the rare sugar D-allulose per meal for 8 weeks to compare changes in the accumulation of areas showing brown adipose tissue (standardized uptake value (SUV) max).

Secondary Outcome

Changes in body composition including body weight, muscle mass, subcutaneous fat mass, and SMI
Ratio of AUC, TIR, TAR, and TBR on continuous blood glucose meter with and without D-allulose intake
AUC (Area Under Curve)
TIR (Time In Range)
TAR (Time Above Range)
TBR (Time Below Range)
Changes in blood test indices such as blood glucose, HbAc, IRI, GLP-1, lipid metabolism, and liver and kidney function
Changes in oral status with and without D-allulose intake

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. adults who are at least 20 years of age at the time of consent
2. adults who can provide written consent to participate in this study
3. adults who have a body mass index (BMI) of at least 18.5 kg/m2 and less than 35 kg/m2 at the time of screening

Exclude criteria

1. severely obese or obese with a BMI of 35 kg/m2 or higher
2. adeults who have experienced serious adverse reactions to D-alulose in the past.
3. Pregnant, parturient, lactating women or women who may become pregnant
4. adeults with severe renal dysfunction (serum eGFR less than 15 ml/min/1.73m2)
5. adeults with other serious complications
6. who are currently participating in another study
7. whose participation in the study, in the opinion of the Principal Investigator or others, would not be in the best interest of the research subjects (e.g., would be detrimental to the welfare of the research subjects) or would interfere with, limit, or confuse the evaluation specific to the clinical research protocol

Related Information

• Primary Sponsor: Fukunaga Kensaku
• Source(s) of Monetary Support: Project for Strengthening the Environment for Innovation Creation at Core Regional Universities