Healthy Diets for a Healthy Weight: Exploring Physiological Mechanisms Related to Dietary Fibre
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change in gut hormones to assess appetite response to dietary fibre
研究概览
简要总结
The investigators present a diet intervention study, to be conducted as a within-subject design, with all food and beverages provided, to allow ad libitum feeding to assess impact of diet change on appetite response. The diets will vary in fibre content and type. This study will allow assessment of the physiological impact of dietary fibre on markers of appetite control for body weight, measured from plasma gut hormones. The investigators propose to recruit participants with a poor diet quality (low habitual fibre intake) to additionally examine the time-course of adaptation of the gut microbiome (measured in faecal samples), whilst assessing the impact of added fibre on body weight and subjective appetite scores. This approach is to address the impact of dietary fibre in people living with obesity and food inequalities. The investigators will assess physiological bio-markers of appetite control and their contribution to the development of a gut ecosystem that promotes health. A subsequent period of return to a low fibre feeding will allow assessment of durability of response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy but overweight/obese (BMI 28-40kg/m2) males and females (post-menopausal, using the oral contraceptive pill or some form of hormonal contraceptive)
- •low habitual fibre intake (<10g/day)
排除标准
- •Medication exclusion criteria:
- •antibiotic use (within the past 3 months due to impact on gut microbiota)
- •statins (current)
- •aspirin or other NSAIDs or anti-coagulants (current)
- •anti-depressants (current)
- •smoking or vaping
- •Medical exclusion criteria:
- •Females who are planning to be pregnant, are pregnant or are breastfeeding
- •Anyone with food allergies, self-reported food sensitivity or intolerance
- •Anyone with coeliac disease or gluten intolerance
- •Anyone taking medication which may affect their appetite
- •Anyone with an eating disorder
- •Anyone with diabetes
- •Anyone with a gastrointestinal disorder, kidney disease, liver disease or gout
- •Anyone suffering from a psychiatric disorder or any type of substance abuse
- •Anyone suffering from unregulated thyroid disease
- •Other exclusion criteria:
- •Anyone following a vegetarian or vegan diet
- •Anyone following a weight loss programme (that may be affecting lifestyle, physical activity & diet)
- •Anyone with unsuitable veins for blood sampling
- •Anyone who is unable to fluently speak, read and understand English
- •Anyone who is unable to comply to an alcohol-free diet for 6 weeks
结局指标
主要结局
Change in gut hormones to assess appetite response to dietary fibre
时间窗: At baseline and end of each arm (study days 0, 14, 28 and 42)
measured by acute and chronic changes in plasma ghrelin and peptide YY (PYY)
Change in subjective hunger to assess appetite response to dietary fibre
时间窗: At baseline and end of each arm (study days 0, 14, 28 and 42)
measured by acute and chronic changes in appetite using visual analogue scale questionnaires
次要结局
- Change in gut metabolites (from faecal samples) in response to dietary fibre(At baseline and end of each arm (study days 0, 14, 28 and 42))
- Change in gut microbiome composition (from faecal samples) in response to dietary fibre(At baseline and end of each arm (study days 0, 14, 28 and 42))
- Change in glycaemic control in response to dietary fibre(At baseline and end of each arm (study days 0, 14, 28 and 42))