NCT04677738已完成不适用
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effects of a Bifidobacterium Breve Strain on Fat Loss in Healthy Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Change in Fat Loss (g)
研究概览
简要总结
Overweight has become a critical issue in North America and the market value of weight loss products is expected to rise as the population becomes more health-conscious and aware of the risks associated with excess body weight. This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterium breve supplementation with exercise intervention on fat loss.
详细描述
In early adulthood, excess body weight is a risk factor associated with several health complications later on in life and probiotics have been used for decades for maintaining intestinal health, and in recent years probiotics have been proposed for weight management. This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterium breve supplementation with exercise intervention on fat loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 20 and 65 years of age, inclusive
- •BMI from 25.0 to 29.9 kg/m2, inclusive
- •Female participants are not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening
- •Or, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- •Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- •Double-barrier method
- •Intrauterine devices
- •Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- •Vasectomy of partner at least 6 months prior to screening
- •Self-reported stable body weight for the past 3 months defined as not having gained or lost more than 5 kg of body weight throughout the 3 months prior to baseline
- •Participants with the following body fat percentages as determined by Bioelectrical Impedance Analysis (BIA):
- •Female: ≥ 30%
- •Male: ≥ 20%
- •Agrees to follow the diet and exercise guidelines for the duration of the study
- •Willingness to complete questionnaires, records, and diaries associated with the study, to complete all clinic visits, and provide stool samples
- •Provide voluntary, written, informed consent to participate in the study
- •Healthy as determined by medical history, laboratory results and physical exam as assessed by the Qualified Investigator (QI)
- •Exclusion Criteria
- •Women who are pregnant, breastfeeding or planning to become pregnant during the trial
- •Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
- •Clinically significant abnormal laboratory results at screening as assessed by the QI
- •Current or history of any significant gastrointestinal disease requiring medication (e.g. GERD, gastroenteritis)
- •Irregular sleep schedule
- •Chronic diarrhea or constipation
- •Participants with hypertension and are on antihypertensive medication
- •Type I or Type II diabetes
- •Participants with hyperlipidemia and are on medication
- •Self-reported sleep apnea
- •Self-reported current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- •Unstable metabolic disease or chronic diseases as assessed by the QI
- •History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom-free for 6 months
- •Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case by case basis
- •Major surgery in the past 3 months or individuals who have planned surgery during the trial period. Participants with minor surgery will be considered on a case-by-case basis by the QI
- •Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- •Individuals with an autoimmune disease or are immune-compromised
- •Self-reported HIV-, Hepatitis B- and/or C-positive diagnosis
- •Blood/bleeding disorders as determined by laboratory results
- •Self-reported mental or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
- •Metal implants that may affect the DXA scan results will be assessed on a case- by-case basis by the QI.
- •Current use of prescribed medications listed in Section Prescribed Medications as follows:
- •Beta-blockers and thiazide diuretics (within 4 weeks of baseline)
- •Weight loss medication (within 4 weeks of baseline)
- •Lipid-lowering medications (within 4 weeks of baseline)
- •Anticoagulants and coagulants (within 4 weeks of baseline)
- •Sleep medication
- •Selective serotonin reuptake inhibitors (SSRI)
- •Antibiotics
- •Non-steroidal anti-inflammatory drugs (NSAIDs)
- •Proton pump inhibitors (PPIs)
- •Metformin (unless on a stable dose for the last 6 months)
- 另有 20 项未显示
排除标准
- 未提供
结局指标
主要结局
Change in Fat Loss (g)
时间窗: 12 weeks from baseline
The difference in change in fat loss from baseline (g), as assessed by Dual-Energy X-Ray Absorptiometry (DXA), between B. breve and placebo after 12 weeks of supplementation. Body tissue density will be measured by a form of X-ray radiation and converted into body fat and muscle mass percentage for assessment
Change in Fat Loss (Percentage of Body Weight)
时间窗: 12 weeks from baseline
The difference in change in fat loss from baseline (percentage of body weight), as assessed by Dual-Energy X-Ray Absorptiometry (DXA), between B. breve and placebo after 12 weeks of supplementation. Body tissue density will be measured by a form of X-ray radiation and converted into body fat and muscle mass percentage for assessment
次要结局
- Body Weight(12 weeks from baseline)
- BMI(12 weeks from baseline)
- Android/Gynoid Fat Ratio(12 weeks from baseline)
- Muscle Mass (g)(12 weeks from baseline)
- Muscle Mass (Percentage of Body Weight)(12 weeks from baseline)
- Waist Circumference(Baseline, 6 weeks and 12 weeks)
- Hip Circumference(Baseline, 6 weeks and 12 weeks)
- Waist/Hip Circumference Ratio(Baseline, 6 weeks and 12 weeks)
- Microbiota Analysis: Shannon Index(12 weeks from baseline)
- Microbiota Analysis: Chao1 Index(12 weeks from baseline)
- Microbiota Analysis: Evenness Index(12 weeks from baseline)
- Microbiota Analysis: Observed ASV Index(12 weeks from baseline)
- Microbiota Analysis: Faith's PD Index(12 weeks from baseline)
- Change in Weight in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Body Mass Index in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Total Body Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Total Body Fat (% of Body Weight) in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Muscle Mass (g) in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Muscle Mass (% of Body Weight) in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Android Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Android Fat (% of Android Tissue) in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Gynoid Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Gynoid Fat (% of Gynoid Tissue) in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Android:Gynoid Fat Ratio in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Waist Circumference in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Hip Circumference in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Change in Waist:Hip Circumference Ratio in Participant Groups Classified by Microbiota Composition at Week 0(12 weeks from baseline)
- Total Cholesterol(Baseline and 12 weeks of supplementation)
- HDL-cholesterol(Baseline and 12 weeks of supplementation)
- LDL-cholesterol(Baseline and 12 weeks of supplementation)
- Triglycerides(Baseline and 12 weeks of supplementation)
- Fasting Blood Glucose(Baseline and 12 weeks of supplementation)
- HbA1c(Baseline and 12 weeks of supplementation)
- Fasting Insulin(Baseline and 12 weeks of supplementation)
- Alkaline Phosphatase (ALP)(Baseline and 12 weeks of supplementation)
- Gamma-glutamyl Transferase (GGT)(Baseline and 12 weeks of supplementation)
- Alanine Aminotransferase (ALT)(Baseline and 12 weeks of supplementation)
- Aspartate Transaminase (AST)(Baseline and 12 weeks of supplementation)
- Frequency of Bowel Movements(Baseline, 6 and 12 weeks of supplementation)
研究者
研究点 (2)
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