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The effect of oyster active peptide and sipunculus nudus active peptide on glucose and lipid metabolism and immune regulation in pre-diabetic population

Clinical study on the effects of oyster active peptide and sipunculus nudus active peptide on glucose and lipid metabolism and immune regulation in pre-diabetic population

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083126
Enrollment
Unknown
Registered
2024-04-16
Start date
2024-04-17
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

Prediabetes

Interventions

Placebo control group:Each patient take 4 tablets (0.6g/ tablet) of microcrystalline cellulose daily with warm water before going to bed for 12 weeks
Oyster peptide control group:Each patient take 4 tablets (0.6g/ tablet) of oyster peptide daily with warm water before going to bed for 12 weeks
Oyster peptide and sipunculus nudus peptide complex intervention group:Each patient take 4 tablets (0.6g/ tablet) of oyster peptide and sipunculus nudus peptide complex daily with warm water before go

Sponsors

Huai 'an District Center for Disease Control and Prevention, Huai 'an City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Male or female aged 18-65 years; (2) All participants were pre-diabetic and had to meet the criteria of HbA1c 5.7=HbA1c(%) < 6.5; (3) No serious liver, kidney, digestive tract diseases, diabetes and other metabolic diseases; (4) Did not use drugs related to lowering blood glucose and blood lipid within 3 months, and agreed not to use drugs during the study; (5) After listening to the introduction of the project, they voluntarily participated in the study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Under the age of 18 or over 65 years old; (2) Allergic to protein; (3) Patients with previously diagnosed diabetes; (4) Previous intervention of blood glucose through diet, physical exercise or other means; (5) Patients with other endocrine and metabolic diseases that may affect blood glucose changes, such as Cushing's syndrome, hyperthyroidism, acromegaly, etc. (6) Patients with severe organic diseases, including cardiovascular and cerebrovascular events, impaired liver function, renal insufficiency, severe chronic gastrointestinal diseases, tumors, acute and chronic infections, etc. (7) Medications affecting blood glucose metabolism within 1 month before screening included glucocorticoids, thiazide diuretics, monoamine oxidase inhibitors, non-steroidal anti-inflammatory drugs, and anabolic steroids. (8) Recently supplemented with additional protein products; (9) Women who are pregnant, lactating or planning to become pregnant or do not use contraception in daily life; (10) Smoking, drinking, or injecting drug users; (11) Those who participated in other clinical trials within the past one month; (12) Those with mental disorder or communication disorder, unable to fully understand the research process, and poor cooperation; (13) Having special dietary habits: vegetarian, weight manager, ketogenic diet (high fat, low carbohydrate), etc.; (14) Unable to follow the requirements of the trial.

Design outcomes

Primary

MeasureTime frame
Body height;Body weight;Waist circumference;Hip circumference;Body mass index;Fasting blood-glucose;Glycosylated hemoglobin;Fasting insulin;Triglyceride;Total cholesterol;High-density lipoproteincholesterol;Low-density lipoprotein cholesterol;Immunoglobulin A;Immunoglobulin E;Immunoglobulin G;Immunoglobulin M;C-reactive protein;

Secondary

MeasureTime frame
Blood pressure;Heart rate;Blood routine index;Liver function index;Renal function index;Apolipoprotein A1;Apolipoprotein B;Lipoprotein;Complement 3;Complement 4;

Countries

China

Contacts

Public ContactHan Jingya

Huai 'an District Center for Disease Control and Prevention, Huai 'an City

826944664@qq.com+86 188 6081 1519

Outcome results

None listed

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