The Acute Effect of Propionate on Energy Homeostasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Changes in Energy Expenditure During Exercise
研究概览
简要总结
The research project aims to examine the effect of a dietary supplement called propionate on how the human body in healthy adults aged (18- 65 years) responds to during fasting, exercise and following a liquid mixed meal test and how that would affect energy homeostasis and substrate oxidation.
详细描述
Dietary fibres have long been recognised for their important role in a healthy diet due to their negative association with, and even management of, chronic diseases such as obesity, diabetes, metabolic syndrome, cardiovascular disease and inflammatory-bowel disease among others.Emerging evidence has suggested that these benefits could largely be attributed to short chain fatty acids (SCFA) (acetate, propionate and butyrate), the main by-products of fibre fermentation in the gut. Previous research has demonstrated that a long-term elevation in the SCFA propionate significantly reduced body weight gain in overweight adults and reduced liver fat storage.
The current project will examine potential mechanisms for the positive effect of propionate on energy homeostasis and metabolic profile.The effects of propionate on circulating glucose, insulin, gut hormones and lipid levels at rest, following moderate-intensity exercise and mixed meal tolerance test will be examined.
To acutely increase propionate absorption from the gut the present project will use a simple nutritional supplement: sodium propionate in a hydroxypropylmethyl cellulose (HPMC) capsule. This capsule is coated with an enteric film which prevents gastric digestion until the capsule reaches the intestine. This nutritional supplement has been used in human volunteers in a previously approved ethics application (12/LO/1769: Oral propionate and glucose homeostasis). A 5g acute dose of sodium propionate had previously been tested and reported no adverse effects . The MHRA have confirmed that encapsulated sodium propionate is not classed as an investigative medicinal product.
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
- Double (Participant, Investigator)
盲法说明
Participants and investigators will be masked to the contents of the capsules (sodium propionate or sodium chloride). They will not be masked to whether it is a resting or exercise or fasting condition as this is not possible.
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
- •Healthy volunteers (body mass index (BMI) of 18-35 kg/m2)
- •Age between 18-65 years (inclusive)
排除标准
- •Weight change of ≥ 3kg in the preceding 2 months
- •Current smokers
- •Substance abuse
- •Excess alcohol intake
- •Pregnancy
- •Cardiovascular disease
- •Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- •Kidney disease
- •Liver disease
- •Pancreatitis
- •Started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
- •Involved in current research or have recently been involved in any research prior to recruitment in the past 12 weeks.
结局指标
主要结局
Changes in Energy Expenditure During Exercise
时间窗: 240 minutes
Changes in Energy Expenditure between sodium propionate and sodium chloride (control) during exercise.
Changes in Resting Energy Expenditure
时间窗: 6 hours
Changes in Resting Energy Expenditure between sodium propionate and sodium chloride (control).
Changes in Energy Expenditure Post-prandially
时间窗: 300 minutes
Changes in Energy Expenditure between sodium propionate and sodium chloride (control) post-prandially.
Changes in Glucose Concentrations During Exercise
时间窗: 240 minutes
Changes in glucose concentrations between sodium propionate and sodium chloride (control) during exercise.
Changes in Subjective Thirst Post-prandially Using a Visual Analog Scale (100 mm).
时间窗: 300 minutes
Changes in subjective thirst between sodium propionate and sodium chloride (control) post-prandially. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst.
Changes in Subjective Nausea During Exercise With Visual Analog Scales (100 mm)
时间窗: 240 minutes
Changes in subjective nausea between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective nausea. High (100 mm) mean high subjective nausea.
Changes in Subjective Hunger During Exercise With Visual Analog Scales (100 mm)
时间窗: 240 minutes
Changes in subjective hunger between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective hunger. High (100 mm) mean high subjective hunger.
Changes in Resting Lipid Oxidation
时间窗: 6 hours
Changes in Resting Lipid Oxidation between sodium propionate and sodium chloride (control).
Changes in Lipid Oxidation During Exercise
时间窗: 240 minutes
Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) during exercise.
Changes in Lipid Oxidation Post-prandially
时间窗: 300 minutes
Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) post-prandially.
Changes in Glucose Concentrations Post-prandially
时间窗: 300 minutes
Changes in glucose concentrations between sodium propionate and sodium chloride (control) post-prandially.
Changes in Subjective Thirst During Exercise With Visual Analog Scales (100 mm)
时间窗: 240 minutes
Changes in subjective thirst between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst.
次要结局
- Changes in Insulin Concentration(300 minutes)
- Changes in Glucose Concentration(360 minutes)
- Changes in GLP-1 Concentration(300 minutes)
- Changes in Free Fatty Acid Concentration(360 minutes)
- Changes in Subjective Hunger Between Sodium Propionate and Sodium Chloride Post-prandially With Visual Analog Scales (100 mm)(300 minutes)
- Changes in Subjective Nausea With Visual Analog Scales (100 mm)(360 minutes)
- Changes in Subjective Thirst Using Visual Analog Scales (100 mm)(360 minutes)
- Changes in Subjective Hunger With Visual Analog Scales (100 mm)(360 minutes)
- Changes in Subjective Nausea Between Sodium Propionate and Sodium Chloride Post-prandially(300 minutes)