Gut microbiota mediated effectiveness of anthocyanins on glucose homeostasis and insulin sensitivity and potential mechanisms of the response variability to anthocyanins treatment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100041743

Enrollment

Unknown

Registered

2021-01-03

Start date

2021-07-01

Completion date

Unknown

Last updated

2021-03-22

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

Conditions

Diabetes

Interventions

high dose group (640 mg/d) :anthocyanins

low dose group (320 mg/d) :anthocyanins

placebo group:placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Men and postmenopausal women aged 45 to 70 years (menopause is defined as menopause >= 12 months, and the number of years of menopause is not more than 10 years); (2) Fasting blood glucose and postprandial blood glucose after 75g oral glucose tolerance test (OGTT) were measured according to the standard method, which met the WHO pre-diabetes diagnostic criteria: fasting blood glucose >= 5.6 but = 7.8 but < 11.0 mmol/L; (3) Body mass index (BMI) of 20~35 kg/m2 with weight change of less than 5% in the last 6 months; (4) Did not consume any drug (such as hormone or steroid, weight loss or anti-inflammatory drugs, etc.) that may affect blood sugar and intestinal flora in the last 6 months; (5) Volunteer to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Suffered from cardiovascular and cerebrovascular diseases such as stroke, coronary heart disease, myocardial infarction, endocrine diseases or severe liver and kidney diseases in the recent 5 years; (2) Had malignant tumor or cancer in the last 5 years or had abnormal vaginal bleeding after menopause; (3) Regular smokers (at least 1 or more a day) or drinkers (with daily alcohol intake exceeding 30g); (4) An acute or chronic infectious disease; (5) Mental illness or cognitive impairment.

Design outcomes

Primary

Measure	Time frame
Indicators of glycemic homeostasis and insulin resistance include glycosylated hemoglobin (HbA1c), fasting and post-OGTT blood glucose at all time points, insulin, and C-peptide levels;Detection of intestinal flora (16sRNA) and its metabolites;Targeted metabolomics of serum and fecal samples;	—

Secondary

Measure	Time frame
Oxidative stress index and inflammatory factors;	—

Countries

China

Contacts

Public ContactZhaomin Liu

Sun Yat-Sen University

liuzhm8@mail.sysu.edu.cn+86 20-87335562

Outcome results

None listed

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