Randomized, Double-blind, Parallel, Placebo-controlled Study to Evaluate the Efficacy of Single Strain Probiotic, Delivered in a Chewing Gum, on the Reduction of Anthropometric Adiposity Biomarkers and the Improvement of Glucose Homeostasis in Abdominally Obese Individuals.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change in waist circumference
研究概览
简要总结
Probiotics have been recognized as functional foods with beneficial effects against obesity and cardiometabolic diseases, such as dyslipidemia, type 2 diabetes and the reduction of visceral fat mass, body weight and waist circumference.
In previous studies, it was shown that capsule/powder probiotic or postbiotic supplementation containing a single strain probiotic, could reduce anthropometric parameters, including the visceral fat area, and contribute to type 2 diabetes management in subjects with abdominal obesity. Similar findings were found when this single strain probiotic was delivered through enriched seafood sticks. Results showed that enriched seafood sticks significantly reduced insulin concentrations and HOMA-IR, pulse pressure, waist circumference, body weight and triglycerides.
These findings suggest that this specific single strain probiotic as a probiotic or postbiotic, could be a complementary strategy in the management of cardiometabolic disease risk factors.
Probiotics have mostly been studied incorporated in dairy food matrix. Other food matrices, such as chewing gum, have scarcely been exploited by the food industry. Chewing gum as a novel vehicle for probiotics presents the ability to release active ingredients into the oral cavity with a steady and rapid action. Furthermore, it has a high acceptance amongst adults and children and present few side effects.
No previous randomized controlled trials have examined the effect of a probiotic chewing gum on anthropometric adiposity biomarkers and glucose homeostasis in abdominally obese individuals.
The main objective of the present study is to evaluate the efficacy of single strain probiotic in the reduction of waist circumference in abdominally obese individuals.
The specific objectives:
- To evaluate the efficacy of single strain probiotic in the improvement of other anthropometric biomarkers (waist-hip-ratio, body weight, BMI, total fat mass, visceral fat index, free fat mass, lean body mass, conicity index, visceral adipose tissue and subcutaneous fat).
- To evaluate the efficacy of single strain probiotic in the management of glucose homeostasis.
- To evaluate the efficacy of single strain probiotic in the management of serum lipid levels.
- To evaluate the efficacy of single strain probiotic in the reduction of blood pressure and pulse pressure.
- To asses Quality of life after single strain probiotic supplementation.
- To identify changes in caloric intake and subjective satiety after single strain probiotic supplementation.
- To identify changes in gastrointestinal health after single strain probiotic supplementation.
- To identify changes in the oral microbiome after single strain probiotic supplementation.
- To identify changes in the gastrointestinal microbiome after single strain probiotic supplementation.
详细描述
A total of 120 adult volunteers will be included in the intervention (60 in each arm of the intervention).
During the CHOICE study, there will be 6 visits in total. Of these visits, 3 will be face-to-face and 3 by telephone. The study visits will be the following: screening visit (V0, face-to-face): to check inclusion/exclusion criteria and, in case of satisfying the inclusion criteria; basal visit (V1, face-to- face); visits during the intervention (V2, V3 and V4 via telephone); final study visit (V5, face-to-face).
In visits V0, V1 and V5 volunteers must present themselves in fasting conditions of 8 hours to obtain blood samples. In visits V1 and V5 volunteers must bring saliva and faeces samples.
In order to measure the changes in visceral adipose tissue, up to five days prior to the visit V1 and approximately up to 3 days prior after the V5, volunteers must have a Nuclear Magnetic Resonance (NMR) for measuring visceral fat.
CHOICE Study
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects ≥ 18 years old.
- •Established diagnosis of abdominal obesity: waist circumference (WC) ≥ 102 cm for men and ≥ 88 cm for women.
- •Voluntary, written, signed, informed consent to participate in the study.
- •Agreement to comply with the protocol and study restrictions.
- •Females of child-bearing potential require to provide a negative urine pregnancy test.
排除标准
- •WC < 102 cm for men, <88 cm for women, and >150 cm.
- •BMI ≥ 40 kg/m
- •Diagnosed and pharmacologically-treated type 1 or type 2 diabetes (fasting blood glucose ≥ 7 mmol/l).
- •Subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease, dementia, pancreatic disease, history of cancer within past 5 years, anemia, or any other disease or condition which, in the Investigator's opinion, could interfere with the results of the study or the safety of the subject.
- •Immunosuppression or ongoing therapy causing immunosuppression.
- •Pharmacologically-treated (medication/supplements) dyslipidemia.
- •Subjects consuming antibiotics in the previous 1 month.
- •Subjects consuming probiotics and prebiotics at least 1 month prior to inclusion in the study or during the intervention period.
- •Use of drugs or supplements to manage body weight or body fat in the last 3 months.
- •Use of laxatives or fiber supplements in the past 4 weeks.
- •History of chronic active inflammatory disorders.
- •History of bariatric surgery.
- •History of any chronic gastrointestinal disease (e.g. IBD).
- •Regular use of systemic or inhaled corticosteroids, or systemic immunomodulatory drugs.
- •Significant change in tobacco, snuff, nicotine and e-cigarette use habits in the past 3 months or planned cessation of the use of these products during the trial.
- •Active or recent (last 3 months) participation in a weight loss program (diet and/or exercise).
- •Weight change (increase or loss) of 3 kg during the past 3 months.
- •Pregnant or planning pregnancy during the study or breastfeeding.
- •Participation in a clinical trial with an investigational product or drug within 60 days prior to screening.
- •Illicit drug users.
- •Alcohol abusers.
- •Known hypersensitivity to any ingredients in the active or placebo products.
结局指标
主要结局
Change in waist circumference
时间窗: From week 0 to Week 12
Difference in waist circumference (cm) measured by an MRI transverse body scan in one axial slice 5 cm over L5 from week 0 to week 12
Changes in intra-abdominal area
时间窗: Week 0 to week 12
Differences in intra-abdominal area (cm2) measured by MRI (transverse body scan in one axial slice 5cm over L5) from week 0 to week 12
次要结局
- Change in Body mass index(From week 0 to Week 12)
- Changes in dietary intake(From week 0 to week 12)
- Change in hip circumference(From week 0 to Week 12)
- Change in waist-hip-ratio(From week 0 to Week 12)
- Change in Body weight(From week 0 to Week 12)
- Changes in gut microbiota(From week 0 to week 12)
- Change in Free fat mass(From week 0 to Week 12)
- Change in Lean body mass(From week 0 to Week 12)
- Change in Conicity index(From week 0 to Week 12)
- Change in Visceral adipose tissue(From week 0 to week 12)
- Changes in HOMA index(From week 0 to Week 12)
- Changes in Three Factor Eating Questionnaire (TFEQ; Spanish edition)(From week 0 to Week 12)
- Change in Visceral fat index(From week 0 to Week 12)
- Change in Subcutaneous fat(From week 0 to Week 12)
- Changes in reflux(From week 0 to week 3, week 6, week 9 and week 12)
- Change in Total fat mass(From week 0 to Week 12)
- Changes in Bing Eating Scale (BES; Spanish edition)(From week 0 to Week 12)
- Changes in abdominal distension(From week 0 to week 3, week 6, week 9 and week 12)
- Changes in Fasting blood glucose(From week 0 to Week 12)
- Changes in glycosylated hemoglobin (HbA1c)(From week 0 to Week 12)
- Changes in Total cholesterol(From week 0 to Week 12)
- Changes in HDLc(From week 0 to Week 12)
- Changes in LDLc(From week 0 to Week 12)
- Changes in Total Triglycerides(From week 0 to Week 12)
- Changes in oral microbiota(From week 0 to week 12)
- Changes in Fasting insulin(From week 0 to Week 12)
- Changes in Diastolic blood pressure(From week 0 to Week 12)
- Changes in Satiety(From week 0 to week 3, week 6, week 9 and week 12)
- Changes in flatulences(From week 0 to week 3, week 6, week 9 and week 12)
- Changes in nausea(From week 0 to week 3, week 6, week 9 and week 12)
- Changes in Systolic blood pressure(From week 0 to Week 12)
- Changes in Pulse Pressure(From week 0 to Week 12)
- Changes in diarrhea(From week 0 to week 3, week 6, week 9 and week 12)
- Changes in bowel habit(From week 0 to week 3, week 6, week 9 and week 12)
- Change in Visceral adipose tissue(From week 0 to Week 12)
- Change in Waist Circumference(Week 0 to week 12)
- Changes in Subcutaneous adipose tissue measured by Ultrasound(Week 0 to week 12)
研究者
Rosa Sola
Doctor, full professor
University Rovira i Virgili