Probiotics' Effects on Hormones, Body and Mood in Obese Women

Wecare Probiotics

Status: Enrolling

Conditions: Obesity, Women

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT07013409

WK20250603

Details and patient eligibility

About

To evaluate the regulatory effect of probiotics formula on visceral fat metabolism and sex hormone balance in obese women.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Age: 18 to 40 years old, female, BMI ≥ 25 kg/m2. Be willing to receive follow-up during the intervention period. Be willing to provide two blood, urine and fecal samples during the intervention period.

Be willing to take the compound probiotics by oneself every day during the intervention period.

Have good hearing and be able to hear and understand all instructions during the intervention period.

Exclusion criteria

Suffering from digestive system diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease).

Suffering from severe neurological disorders (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, long-term coma - excluding general anesthesia).

Have received/are currently receiving treatment for the following mental illnesses: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder.

Take medication for depression or low mood. Suffering from internal organ failure (such as heart, liver or kidney failure, etc.).

Have received radiotherapy or chemotherapy in the past. Have received general anesthesia surgery/procedures within the past three years, or plan to receive general anesthesia procedures/surgeries within the next three months during this trial.

Have suffered from hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Probiotic Group

Experimental group

Description:

Take 30 billion CFU of complex probiotics every day (Lacticaseibacillus rhamnosus LRa05: Limosilactobacillus reuteri LR08= 1:1).

Treatment:

Dietary Supplement: Probiotic

Placebo Group

Placebo Comparator group

Description:

Taking maltodextrin 3 g/day.

Treatment:

Dietary Supplement: Maltodextrin