A Double-Blind, Randomized Placebo-Controlled Study to Evaluate a Postbiotic Supplement in Supporting Weight Loss and Metabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- To determine the effect of resM™ on blood metabolic markers
研究概览
简要总结
This study aims to evaluate the impact of a specific oral postbiotic supplement on metabolic health in overweight adults.
详细描述
Obesity poses substantial health challenges contributing significantly to chronic metabolic disorders such as type 2 diabetes mellitus, cardiovascular disease, and diminished quality of life for people worldwide. Central to obesity-related metabolic dysfunction is dysregulation of appetite control, glucose homeostasis, insulin sensitivity, and systemic inflammation. Evidence indicates a strong connection between these metabolic disturbances and alterations in the gut microbiome, implicating microbiota dysbiosis as a potential target for intervention. Microbiome-based interventions underscore a promising approach in weight management and metabolic health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide voluntary signed and dated informed consent.
- •Be in good health as determined by medical history.
- •Age between 18 and 65 yr (inclusive).
- •Body Mass Index of 25.0 - 40.0 (inclusive).
- •Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
- •Agree to refrain from other probiotic and postbiotic supplement products throughout the duration of the trial.
- •Subject is willing and able to comply with the study protocol.
- •Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
排除标准
- •History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
- •Alcohol abuse (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
- •Previous bariatric surgery.
- •Current smokers or smoking within the past month.
- •History of hyperparathyroidism or an untreated thyroid condition.
- •History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- •Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, irritable bowel syndrome (IBS), diarrheal illnesses, history of colon resection, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
- •Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, ulcerative colitis, Lupus, HIV/AIDS, etc.).
- •Previous medical diagnosis of gout or fibromyalgia.
- •Pregnant women, women trying to become pregnant, women less than 120 days postpartum or nursing women. Any woman that is sexually active will have to take report their pregnancy status prior to enrolling and during the trial if they become pregnant.
- •Known sensitivity to any ingredient in the test formulations as listed in the product label.
- •Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
研究组 & 干预措施
Placebo
1 capsule of placebo, taken once daily
干预措施: Placebo (Dietary Supplement)
Postbiotic Supplement
1 capsule of 40 mg postbiotic, 450 mg herbal blend, and 810 mcg vitamins taken once daily
干预措施: Postbiotic (Dietary Supplement)
结局指标
主要结局
To determine the effect of resM™ on blood metabolic markers
时间窗: 8 weeks
Change from baseline in serum fasting glucose
To determine the effect of resM™ on weight
时间窗: 8 weeks
Change from baseline in weight (lb)
To determine the effect of resM™ on BMI
时间窗: 8 weeks
Change from baseline in BMI. Weight and height will be combined to report BMI in kg/m\^2)
To determine the effect of resM™ on food cravings
时间窗: 8 weeks
Change in reported food cravings from baseline based on Food Craving Questionnaire Trait-reduced (FCQ-T-r) scores. The total score reflects the severity of food cravings where 90 indicates the most severe and 15 indicates the least severe.
次要结局
- To determine the effect of resM™ on GLP-1(8 weeks)
- To determine the effect of resM™ on DPP-4(8 weeks)
- To determine the effect of resM™ on gut microbiome(8 weeks)
- To determine the effect of resM™ on depression(8 weeks)
- Change in Albumin after taking resM™(8 weeks)
- Change in Albumin/Globulin ratio after taking resM™(8 weeks)
- Change in Alkaline Phosphatase after taking resM™(8 weeks)
- Change in Alanine Aminotransferase (ALT) after taking resM™(8 weeks)
- Change in Aspartate Aminotransferase (AST) after taking resM™(8 weeks)
- Change in BUN/Creatinine ratio after taking resM™(8 weeks)
- Change in Calcium after taking resM™(8 weeks)
- Change in Chloride after taking resM™(8 weeks)
- Change in Glucose after taking resM™(8 weeks)
- Change in Sodium after taking resM™(8 weeks)
- Change in Total Bilirubin after taking resM™(8 weeks)
- Change in Total Protein after taking resM™(8 weeks)
- Change in Urea Nitrogen after taking resM™(8 weeks)
- Change in White Blood Cell (WBC) count after taking resM™(8 weeks)
- Change in Red Blood Cell (RBC) count after taking resM™(8 weeks)
- Change in Hemoglobin (Hb) after taking resM™(8 weeks)
- Change in Hematocrit (Hct) after taking resM™(8 weeks)
- Change in Mean Corpuscular Volume (MCV) after taking resM™(8 weeks)
- Change in Mean Corpuscular Hemoglobin (MCH) after taking resM™(8 weeks)
- Change in Mean Platelet Volume (MPV) after taking resM™(8 weeks)
- Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resM™(8 weeks)
- Change in Red Cell Distribution Width (RDW) after taking resM™(8 weeks)
- Change in Platelet Count after taking resM™(8 weeks)
- Change in Neutrophils after taking resM™(8 weeks)
- Change in Lymphocytes after taking resM™(8 weeks)
- Change in Monocytes after taking resM™(8 weeks)
- Change in Eosinophils after taking resM™(8 weeks)
- Change in Basophils after taking resM™(8 weeks)
- Safety - participants experiencing adverse events(8 weeks)
- Safety - total adverse events(8 weeks)