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Allulose population-based intervention study

Allulose population-based intervention study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100081
Enrollment
Unknown
Registered
2025-04-02
Start date
2025-04-02
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Healthy participants

Interventions

Sucrose group (20 g/d):20 g/d Sucrose
Low-dose allulose group (20 g/d):20 g/d allulose
High-dose allulose group (30 g/d):30 g/d allulose
Blank control group:Pure water

Sponsors

Nankai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Healthy subjects aged between 18 and 60 years, with a BMI of 20-30 kg/m^2 (inclusive), who self-reported stable weight in the past 6 months (weight loss or gain not exceeding 5 kg within 6 months prior to screening). They should voluntarily participate and commit to complying with the requirements of lifestyle management. From 4 weeks before the intervention to the end of the intervention, they should discontinue the use of any vitamins, minerals, dietary, or other supplements.

Exclusion criteria

Exclusion criteria: 1.Diagnosed diabetes or abnormal glucose metabolism detected during screening (Based on the "Expert Consensus on the Prevention and Treatment of Prediabetes in Chinese Adults (2023 Edition)": Abnormal glucose metabolism is defined as fasting blood glucose >=6.1 mmol/L and glycated hemoglobin >5.7%). 2.Diagnosed dyslipidemia or abnormal lipid metabolism detected during screening (Based on the "Chinese Guidelines for Lipid Management (2023)": Abnormal lipid metabolism is defined as total cholesterol (TC) >5.2 mmol/L, low-density lipoprotein cholesterol (LDL-C) >3.4 mmol/L, triglycerides (TG) >=1.7 mmol/L, and high-density lipoprotein cholesterol (HDL-C) =140/90 mmHg). 4.Abnormal blood routine. 5.Abnormal liver function (alanine aminotransferase, aspartate aminotransferase, direct bilirubin, indirect bilirubin, total bilirubin, alkaline phosphatase (ALP)); Abnormal renal function (serum creatinine, blood urea nitrogen, serum uric acid, urine glucose, urine ketone bodies), or presence of one or more renal injury markers: albuminuria/proteinuria, abnormal urine sediment (e.g., hematuria). 6.Any history of gastrointestinal diseases or other diseases that may affect the study results, or diagnosed with the following diseases: including but not limited to irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, gastrointestinal diseases, endocrine diseases, hematologic diseases, respiratory and cardiovascular diseases, hyperthyroidism or hypothyroidism; severe infections, severe anemia, neutropenia, and other hematologic disorders; presence of psychiatric diseases or dementia. 7.Use of any thyroid medications, lipid-lowering agents, hepatoprotective drugs, antihyperglycemic agents, antihypertensive drugs, antidepressants, or weight-loss medications within the past 3 months. 8.Presence of other infectious diseases, such as hepatitis A, hepatitis B, hepatitis C, and acquired immunodeficiency syndrome. 9.Pregnant or planning to become pregnant within 6 months, or breastfeeding. 10.Participation in another clinical trial within the past 3 months. 11.Refusal to participate or refusal to sign the informed consent form, as well as those deemed ineligible by the investigator. 12.Smoking (more than one pack per week) or habitual alcohol consumption (more than twice per week). 13.Use of probiotics, prebiotics, antioxidants, fish oil, or other nutritional supplements within the past 3 months; consumption of yogurt within 1 week before the initial visit, or use of antibiotics within the past 3 months.

Design outcomes

Primary

MeasureTime frame
GSRS;

Secondary

MeasureTime frame
Blood biomarkers;Urinary biomarkers;Gut microbiota;Body composition and measurements;Blood pressure;

Countries

China

Contacts

Public ContactShuo Wang

Nankai University

wangshuo@nankai.edu.cn+86 22 85358523

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026