Determination of the Acute Glycemic and Insulinemic Response of FOSSENCE™ Alone, or When Substituted or Added to a Carbohydrate Challenge: A Three-phase, Acute, Randomized, Cross-over, Double Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- incremental area under the 2 hour (120 minutes) blood glucose curve
研究概览
简要总结
Short chain fructooligosaccharide (FOS) is known as a prebiotic fiber/nutrient and has been documented to demonstrate different health benefits including glucose control, gut health, mineral absorption, weight and immunity.
FossenceTM is a short chain fructo-oligosaccharide (scFOS), sweet tasting, soluble prebiotic dietary fibre which is produced through Tata Chemicals Limited's patented process and is currently US GRAS notified (safe for consumption). The formulation and properties of scFOS suggest that the molecule may potentially play a role in glucose and insulin metabolism.
The purpose of this study is to explore the rise of glucose and insulin in the blood after consuming FossenceTM that has been added or substituted into a sugar drink or white bread.
详细描述
BACKGROUND Short chain fructooligosaccharide (FOS) is known as a prebiotic fiber/nutrient and has been documented to demonstrate different health benefits including attenuation of postprandial glycemia, gut health, mineral absorption, satiety & weight management and immunity.
FossenceTM is short chain fructo-oligosaccharide (scFOS), a sweet tasting, soluble dietary fibre which is produced through Tata Chemicals Limited's patented process. These properties of scFOS suggest that the molecule may potentially play a role in glucose and insulin metabolism. The proposed 3 phase study will therefore explore the properties of FossenceTM with respect to its fibre like properties (not digested in the human small intestine), and its effect on postprandial glycemia when added or substituted into a simple (dextrose) or complex (white bread) carbohydrate load.
OBJECTIVES The purpose of this 3 phase study is to: 1. Demonstrate that consumption of scFOS does not increase postprandial blood glucose levels, 2. Explore the effects when scFOS is either added or substituted into a simple carbohydrate load (dextrose) or 3. Into a complex carbohydrate food (white bread).
PARTICIPANTS Twenty five healthy adult males and non-pregnant, non-lactating females, aged 18-65 years with BMI between 18 and 30 kg/m2 are required for each phase.
DESIGN The study is a double-blind, randomized, cross-over trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Blood pressure < 140/90 mmHg
- •No major illness or surgery requiring hospitalization within 3 months of the first study visit after screening
- •No history of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- •Subject may be a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit
- •Willing to maintain habitual diet, physical activity pattern, and body weight throughout the study
- •Subjects must be eligible to receive income in Canada and must demonstrate Ontario Health Insurance Program coverage
排除标准
- •Failure to meet all the inclusion criteria
- •Previous bariatric procedure
- •No chronic disease such as type-1 or type-2 diabetes mellitus (fasting blood sugar levels <100 mg/dL (or <5.6 mmol/L) as assessed at the first visit)
- •No gastro-intestinal disorder such as Crohn's disease, coeliac disease, irritable bowel syndrome
- •Medications known to affect glucose tolerance -but stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension, hyperlipidemia, anxiety/depression or osteoporosis are acceptable
- •Any known food allergies or intolerances
- •No strong dislike of or intolerance to sweetened beverages or inulin
- •Alcohol consumption of no more than 10 drinks per week for women and 15 drinks per week for men. One drink is defined as either 5oz wine, 341ml of beer/cider or 1.5 oz distilled alcohol
- •History of cancer in the prior two years, except for non-melanoma skin cancer
- •Participants who do not understand English
- •Presence of any condition, illness or drug use, which in the opinion of Dr. Wolever, increases the risk to the subject or to others or may affect the results
研究组 & 干预措施
scFOS treatment #1
Phase 1: 10g of scFOS Phase 2: 50g dextrose +15g scFOS Phase 3: 50g avCHO from white bread +15g scFOS
干预措施: scFOS (Dietary Supplement)
scFOS treatment #2
Phase 1: n/a Phase 2: 35g Dextrose +15g scFOS Phase 3: 35g avCHO from white bread +15g scFOS
干预措施: scFOS (Dietary Supplement)
Control #1
Phase 1: Water control (negative control) Phase 2: 35g Dextrose control 1 Phase 3: 35g avCHO from white bread (control 1)
干预措施: Control (Other)
Control #2
Phase 1: 10g Dextrose (positive control) Phase 2: 50g Dextrose control 2 Phase 3: 50g avCHO from white bread (control 2)
干预措施: Control (Other)
结局指标
主要结局
incremental area under the 2 hour (120 minutes) blood glucose curve
时间窗: 0-120 minutes
The mean glucose concentration in the 2 fasting blood samples will be used as the fasting concentration for the purposes of calculating incremental area under the glucose response curve (IAUC), ignoring area below fasting
次要结局
- incremental area under the 2 hour (120 minutes) blood insulin curve(0-120 minutes)
- comparison of the glucose and insulin levels at individual time points from 0-120min(0-120 minutes)