To observe the gastrointestinal tolerance of D-allulose.
Conditions
Interventions
low-dose Group(Part I Gastrointestinal Tolerance study of D-allulose in human population):Oral ingestion of D-allulose(24g/person/day)
Metabolic syndrome population group(Part II Study on the efficacy and safety of D-allulose consumption in human population):Oral ingestion of D-allulose(24g/person/day)
High-dose Group(Part I Gastrointestinal Tolerance study of D-allulose in human population):Oral ingestion of D-allulose(36g/person/day)
Healty people Group(Part II Study on the efficacy and safety of D-allulose consumption in human population):Oral ingestion of D-allulose(24g/person/day)
Sponsors
Beijing Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Part I Gastrointestinal Tolerance study of D-allulose in human population: Inclusion criteria: (1) Adult men and women aged 18-65 years with a body mass index within the normal range (18.5 =7mmol/L or the blood glucose level is >=11.1mmol/L or the A1c is >=6.5%. c Body mass index > 24; Voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1.Part I Gastrointestinal Tolerance study of D-allulose in human population: Exclusion criteria: (1) pregnant and lactating women;(2) Patients diagnosed with diabetes who take oral hypoglycemic drugs or inject insulin; (3) Diagnosed with hyperlipidemia; (4) Patients diagnosed with hypertension taking diuretics; (5) Patients with serious systemic diseases such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system; (6) Severe gastrointestinal disease, gout or porphyria; (7) Have mental problems, such as depression, schizophrenia, alcoholism, drug poisoning.;(8) History of surgery within 6 months;(9) Functional foods that may have influenced the results of this study are being used; (10) Have been diagnosed with cancer or are receiving related treatment; (11) Asthma or other allergies; (12) Frequent drinking or smoking; (13) Those who have other concomitant diseases under treatment;(14) Participants considered unsuitable for clinical trials. 2.Part II Study on the efficacy and safety of D-allulose consumption in human population: Exclusion criteria:(1) Pregnant and lactating women; (2) Patients diagnosed with hypertension taking diuretics;(3) Patients with serious systemic diseases such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system;(4) Severe gastrointestinal disease, gout or porphyria;(5) Have mental problems, such as depression, schizophrenia, alcoholism, drug poisoning;(6) Surgical history within 6 months;(7) Functional foods that may have influenced the results of this study are being used; (8) Have been diagnosed with cancer or are receiving related treatment;(9) Asthma or other allergies;(10) Frequent drinking or smoking;(11) Those who have other concomitant diseases under treatment;(12) Participants considered unsuitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Chemistry Test (including liver and kidney function index, blood glucose, blood lipid), K, Na, CL;;Haematology Test;Routine urine test;Routine clinical stool test;General physical examination (height, weight, BMI index; Blood pressure, heart rate, waist circumference, skinfold thickness; Body fat percentage, muscle mass, body composition analysis; Bone mineral density);Fasting blood glucose; 2-hour postprandial blood glucose; Glycated hemoglobin A1c(Part II Study); | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiogram test;X-ray Examination of the Chest;HCG Blood Pregnancy Test (restricted to women);B ultrasound of the upper abdomen test; | — |
Countries
China
Contacts
Public ContactShan Gao
Beijing Center for Disease Prevention and Control
Outcome results
None listed