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The safety and effect of a new sweetener (Lacritose) compared to sugar and glucose on postprandial blood sugar

The effects of a newly designed natural sweetener (Lacritose) compared to sucrose and glucose on blood glucose concentrations and possible gastrointestinal reactions in patients with type 2 diabetes: a double-blind randomized three way cross-over clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015050912571N2
Enrollment
20
Registered
2016-09-15
Start date
2016-02-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Non-insulin-dependent diabetes mellitus. non insulin dependent diabetes mellitus

Interventions

Intervention 1: 50 grams of Lacritose dissolved in 300 ml of tap water. Intervention 2: 50 grams of sucrose dissolved in 300 ml of tap water. Intervention 3: 50 grams of glucose dissolved in 300 ml of
Treatment - Drugs
Placebo
50 grams of Lacritose dissolved in 300 ml of tap water
50 grams of sucrose dissolved in 300 ml of tap water
50 grams of glucose dissolved in 300 ml of tap water

Sponsors

Vice chancellor for research, Shahid Sadoughi University of Mecical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Type 2 diabetic patients (n=20) with fasting blood sugar >125 mg/dl and lower than 200 mg/dl, aged 20 to 60. Exclusion criteria: Participants will not be included in the trial if they were pregnant or lactating, had severe infection, endocrine disorders or acute diseases at the enrollment. Participants who intend to exit with any reasons or show any adverse reaction to test sugars will also be excluded from the study. .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Postprandial blood sugar. Timepoint: Every 30 minutes up to 2 hours after ingesting the test beverages. Method of measurement: Using pars azmoon kits using automated azalyzer.

Secondary

MeasureTime frame
Gastrointestinal symptoms. Timepoint: 24 hour after ingesting the test beverages. Method of measurement: Gastrointestinal symptoms questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Amirhoushang Mehrparvar

Shahid Sadoughi University of Medical Sciences

ah.mehrparvar@gmail.com+98 35 3726 6711

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 3, 2026