The Effect of Meal Viscosity on Postprandial Metabolic, Gut Hormone and Satiety Responses to Low and High Glycemic Index Preload Meals in Overweight Pre- and Post-menopausal Women.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To investigate the effects of viscous polysaccharide fibers on postprandial meal-associated metabolic response patterns.
研究概览
简要总结
In this research study, investigators are interested in how certain dietary fibers in the diet affect certain hormones released from your intestine after eating and how these influence your appetite. The study hypothesis is that certain fibers will slow digestion and absorption of nutrients thereby optimizing fullness,reducing food intake and limiting insulin response in pre- and post-menopausal women.
详细描述
This study is designed to gain a better understanding of meal viscosity and the utility of dietary sources of viscous polysaccharide fibers to modulate postprandial metabolic and satiety mechanisms in pre- and post- menopausal overweight women in order to optimize acute metabolic responses to meals as well as most favorably affect appetite, food intake and overall body weight control.
Objectives of this study include:
- To investigate the effects of viscous polysaccharide type fibers in a meal on postprandial intestinal-phase mechanisms of satiety [eg., cholecystokinin (CCK)] and meal-associated metabolic (eg., glucose, insulin, triglyceride) response patterns to low glycemic index (GI), fiber-controlled preload meals compared to a low fiber, high GI meal in overweight pre- and post- menopausal women.
- To characterize the subjective and behavioral satiety responses to study-specific preload meals varying in viscous fiber content as well as determine the relationship of these satiety responses to the preload-associated physiological responses in overweight pre- and post- menopausal women.
- To examine the influence of menopausal status of overweight women on the physiological, subjective and behavioral responses to study preloads.
The study is a randomized, 3-arm, 6-sequence, within-subjects, crossover, treatment-controlled study utilizing a repeated measures, multiple sampling paradigm to evaluate the metabolic and satiety response pattern to low glycemic index (GI) fiber-controlled preload treatments differing in viscous fiber content compared to a high GI preload meal.
The study will test 3 isocaloric treatment preloads in relatively healthy overweight, mildly obese, pre- and post- menopausal women. Preload meals will be prepared as breakfast meals using muffins and yogurt beverage / shake as the base for which glycemic index (GI) of the meal, including fiber / viscous fiber content, will be manipulated. All preloads have been matched as close as possible on sensory qualities as well as macronutrient composition, fiber and energy content and volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Unrestrained [score ≤ 10] on the Eating Inventory (EI) questionnaire
- •Pre-menopausal with spontaneous cycle
- •Post-menopausal ≥ 12 month without menstruation
- •Body mass index (BMI) of either 25 to 33 kg/m2, inclusive
排除标准
- •Pregnant and lactating
- •Allergies or intolerances to foods consumed in the study
- •Fasting glucose > 110 mg/dL
- •Active modification to diet or exercise patterns to gain or lose weight in previous 60 days
- •Unstable body weight (fluctuations of ≥ 5 kg in 60 day period)
- •Excessive exercisers or trained athletes
- •Taking any medications that would affect appetite or have a current or past (previous 1 year) medical condition that may interfere with any of the outcomes of this study.
- •Hormonal therapy (ie., estrogen, progesterone)
研究组 & 干预措施
Low GI high fiber non-viscous meal
20:80 ratio of viscous polysaccharide fiber source to insoluble non-viscous producing fiber
干预措施: Low GI high fiber non-viscous (Dietary Supplement)
High GI low fiber meal
No fiber control meal
干预措施: No fiber (Dietary Supplement)
Low GI high fiber viscous meal
80:20 ratio of viscous polysaccharide fiber to insoluble non-viscous producing fiber
干预措施: Low GI high fiber viscous meal (Dietary Supplement)
结局指标
主要结局
To investigate the effects of viscous polysaccharide fibers on postprandial meal-associated metabolic response patterns.
时间窗: 0, 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes
Plasma glucose, insulin, and triglyceride concentrations measured by Randox Clinical analyzer
To investigate the effects of viscous polysaccharide fibers on postprandial satiety.
时间窗: 0, 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes
Effect of Different Treatments on Cholecystokinin (CCK) Concentration
次要结局
- To characterize the subjective and behavioral satiety responses to study-specific preload meals varying in viscous fiber content as well as determine the relationship of these satiety responses to the preload-associated physiological responses.(0, 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes)