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