NCT04515277已完成不适用
Double-blind, Randomized, Controlled, Three-way Cross-over Study to Evaluate the Effect of Gum Acacia (FibregumTM) on Post-prandial Glucose and Insulin Levels and Food Intake
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nexira
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Difference in blood glucose incremental AUC 0-120 min between D1 verum group and no treatment group
研究概览
简要总结
Study to evaluate the effect of gum acacia (FibregumTM) on post-prandial glucose and insulin levels and food intake in normal-weight and overweight subjects during a 2-7 weeks intervention period. In addition, tolerability and safety of gum acacia (FibregumTM) will be assessed.
详细描述
Gum arabic is a heteropolysaccharide (molecular weight 350-850 kDa) harvested from Acacia seyal or Acacia senegal. It is highly soluble and broadly used in numerous solid and liquid food matrices.
For the assessment of non-digestible carbohydrates as dietary fiber, it is eminent to demonstrate that its consumption is related to a specific beneficial physiological effect shown in an appropriate clinical study. The aim of the present trial was to expand the clinical evidence with respect to beneficial effects of gum acacia on post-prandial blood glucose levels, post-prandial insulin levels and prospective ad libitum food intake, in normal-weight and overweight subjects.
The present double-blind, randomized, controlled, three-way cross-over study was to evaluate the effect of gum acacia versus no treatment on post-prandial glucose (PPG) levels in normal-weight and overweight subjects during a 2-7 weeks intervention period.
Additionally, post-prandial insulin (PPI) levels, prospective ad libitum food intake, as well as the safety and tolerability of gum acacia were assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women from 25 to 60 years old
- •Body mass index (BMI) 18.5 kg/m2 - 29.9 kg/m2
- •Generally in good health
- •Normal fasting blood glucose (FBG) 3.9 to <5.6 mmol/L (70 to <100 mg/dL) and HbA1c of 4 to <5.7 %
- •Regularly consuming 3 main meals/day, with breakfast and lunch as dominant meals
- •Familiar with components of the study meals, no disliking and/or extreme preferences for any of the items
- •Readiness to comply with study procedures, in particular:
- •adhere to the defined restrictions prior to / procedures on the test days
- •maintain the habitual level of physical activity and sleep habits during the study
- •fill out the study diary
- •Stable body weight in the last 3 months prior to V1 (≤3% self-reported change)
- •Stable concomitant medications (if any) for at least last 3 months prior to V1
- •Women of childbearing potential:
- •commitment to use contraception methods
- •negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- •Readiness not to participate in another clinical study during this study
排除标准
- •Known allergy or hypersensitivity to the components of the investigational product / study meals
- •History and/or presence of clinically significant self-reported disorder as per investigator's judgement:
- •untreated or non-stabilized thyroid gland disorder
- •untreated or non-stabilized hypertension (regular systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
- •digestion/absorption disorders of the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.) and/or GI surgery
- •diabetes mellitus
- •sleep disorder
- •acute or chronic psychiatric disorder
- •any other organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject
- •Subjects with difficult vein access or sensitive to blood draws
- •Nighttime eating/snacking (after 10 pm)
- •Excessive consumption of artificial sweeteners (e.g. in beverages)
- •History and/or presence of eating disorders like bulimia, anorexia nervosa, binge-eating as per investigator's judgement
- •Use of treatment/supplementation in the last 2 months prior to V1 and during the study, as per investigator's judgment, that could influence gastrointestinal functions, body weight, blood glucose levels or otherwise interfere with study conduct / evaluation
- •Deviation of safety laboratory parameter(s) at V1 (except for Hb and HbA1c) that is:
- •clinically significant or
- •>2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
- •Diet/weight loss programs within the last 3 months prior to V1 and during the study
- •Recent blood donation within the last 1 month prior to study
- •Smoking within the last 6 months prior to V1 and during the study
- •Vegetarian, vegan or other restrictive diet
- •Night shift work
- •History or current abuse of alcohol, drug and/or medication
- •Women of child-bearing potential: pregnancy or nursing
- •Inability to comply with study procedures
- •Participation in another study during the last 30 days prior to V1
- •Any other reason deemed suitable for exclusion, per investigator's judgment
结局指标
主要结局
Difference in blood glucose incremental AUC 0-120 min between D1 verum group and no treatment group
时间窗: 2 -7 weeks
Venous blood samples were drawn for the determination of glucose values, with sampling times at -15 min and immediately prior to the intake of the standardized breakfast (time "0") as well as 15, 30, 45, 60, 90 and 120 min after the "0 min" blood draw.
次要结局
- Difference in blood glucose incremental AUC 0-120 min between D2 verum group and no treatment group(2 -7 weeks)
- Food (energy) intake at ad libitum lunch, in comparison between each verum group vs no treatment group(2 -7 weeks)
- Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - VAS values at all time points 0, 15, 30, 45, 60, 90, 120, 180, 210, 240 min(2 -7 weeks)
- Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - maximal/minimal VAS values(2 -7 weeks)
- Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min(2 -7 weeks)
- Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min(2 -7 weeks)
- Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - VAS values at all time points 0, 15, 30, 45, 60, 90, 120, 180, 210, 240 min(2 -7 weeks)
- Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - maximal/minimal VAS values(2 -7 weeks)
- Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min(2 -7 weeks)
- Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min(2 -7 weeks)
- 24 hour energy intake on test days: breakfast+ad libitum lunch+diary records, in comparison between each verum group vs no treatment group(2 -7 weeks)
- PPG, in comparison between each verum group vs no treatment group - concentration at all time points 0, 15, 30, 45, 60, 90, 120, 180 min(2 -7 weeks)
- PPG, in comparison between each verum group vs no treatment group - maximal concentration(2 -7 weeks)
- PPG, in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180 min(2 -7 weeks)
- PPG, in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-180 min(2 -7 weeks)
- PPI, in comparison between each verum group vs no treatment group - concentration at all time points 0, 15, 30, 45, 60, 90, 120, 180 min(2 -7 weeks)
- PPI, in comparison between each verum group vs no treatment group - maximal concentration(2 -7 weeks)
- PPI, in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180 min(2 -7 weeks)
- PPI, in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180 min(2 -7 weeks)
- Global evaluation (by 4-point scale) of benefit by subject and the investigator, in comparison between each verum group vs no treatment group(2 -7 weeks)
研究者
研究点 (2)
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