Guar Gum Trial in Type 2 Diabetes Patients

JRCT ID: jRCT1051240099

Registered date:24/07/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 24/07/2024
• Target sample size: 108
• Study type: Interventional

Intervention(s)

Intervention Group: Dissolve one packet of guar gum hydrolysate (5.15g, containing 5.0g of guar gum hydrolysate and 0.15g of cellulose) in a drink and consume twice daily before meals.
Control Group: Dissolve one packet of dextrin (5.15g) in a drink and consume twice daily before meals.

Outcome(s)

• Primary Outcome: The gut microbiota at the , particularly the proportion of Akkermansia in the total gut bacteria.

Secondary Outcome

Gut microbiota 90 days after consuming the test food
HbA1c 90 days after consuming the test food
Short-chain fatty acids 90 days after consuming the test food

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) Patients who have provided written consent of their own free will.
2) Males and females aged 20 years or older and under 80 years at the time of consent.
3) Patients diagnosed with type 2 diabetes.
4) Patients with an HbA1c value of 6.5% or higher within 37 days prior to obtaining consent.

Exclude criteria

1) Patients with cognitive impairment who cannot fully understand the purpose or methods of this study.
2) Patients who started diabetes medications within 5 months prior to obtaining consent.
3) Patients who had a change in diabetes medications within 2 months prior to obtaining consent.
4) Patients undergoing insulin therapy.
5) Patients scheduled for surgery during the study period.
6) Patients with hypersensitivity to dietary fiber or a history of adverse reactions to dietary fiber intake.
7) Patients with severe gastrointestinal symptoms or gastrointestinal diseases.
8) Women who are breastfeeding, pregnant, or have a positive pregnancy test, and women who wish to become pregnant during the study period.
9) Other patients deemed unsuitable as study subjects by the principal or sub-investigator.

Related Information

• Primary Sponsor: Nakashima Koya
• Source(s) of Monetary Support: HEALTHY PASS Inc.,Taiyo Kagaku Co.,Ltd.