NCT05540678终止不适用
The FibreGum Study - Changing the Course of Obesity in Children
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Reduction in the Body Mass Index (BMI) Z-score
研究概览
简要总结
The aim of this study is thus to assess the effect of a chewing gum containing fibres on body weight, metabolism and the oral and intestinal microbiomes in a population of obese children.
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
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (ICH/GCP) regulations prior to any study specific procedures
- •Obesity as determined by a BMI ≥97th percentile using the Swiss paediatric, age- and sex-matched growth charts
- •Newly referred within the last month to a tertiary weight management clinic
- •Participant willing to use the study specific monitoring app on his/her own or legal representatives' smartphone
排除标准
- •Antibiotic administration in the last 6 months
- •Pre- or probiotic treatment in the last 6 weeks
- •Any professionally supervised treatment for weight management within the last year
- •Consumption of more than one nicotine product per month (e.g. cigarette, gum)
- •Adolescent females: any stages of known pregnancy or lactation period
- •Congenital disorder affecting the cardiovascular, hepatic or respiratory system in a relevant way (as per PI's or specialist's evaluation)
- •Malignant disease on treatment or previous tumour affecting the appetite system (e.g., suprasellar, hypothalamic tumours)
- •Systemic antibiotic or anti-inflammatory medication (e.g. systemic intake of glucocorticoids) over the last 7 days
- •Known eating disorder (medically diagnosed)
- •Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
- •Dependency from the sponsor or the clinical investigator
- •Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, etc. of the participant and/or legal representative
研究组 & 干预措施
Placebo
Placebo Comparator
Chewing gum containing maltitol powder
干预措施: Placebo (Dietary Supplement)
Investigational
Experimental
chewing gums containing fibers
干预措施: FibreGum (Dietary Supplement)
No-treatment control
No Intervention
No study chewing gum
结局指标
主要结局
Reduction in the Body Mass Index (BMI) Z-score
时间窗: 6 months
Difference in the BMI Z-scores measured at study start and study completion
次要结局
- Fasting blood glucose change(6 months)
- Fasting insulin change(6 months)
- Systolic and diastolic blood pressures changes(6 months)
- HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change(6 months)
- Hemoglobin A1c (HbA1c) change(6 months)
- Intestinal health(6 months)
- Alanine Aminotransferase (ALAT) change(6 months)
- Thyroid-Stimulating Hormone (TSH) change(6 months)
- Ferritin change(6 months)
- Proteinuria(6 months)
- Lipid-profiles change(6 months)
- Differential blood count change(6 months)
- Calprotectin and lipocalin-2 change in stool(6 months)
- Oral health(6 months)
- Descriptive analysis of treatment adherence using data from an adherence-tracking app(6 months)
- Calcifediol (25OH-Vitamin D3) change(6 months)
研究者
研究点 (2)
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