Propionate and Energy Homeostasis
Ключові слова
Анотація
Опис
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.
Дати
| Востаннє перевірено: | 09/30/2019 |
| Перший поданий: | 08/04/2019 |
| Орієнтовна реєстрація подана: | 09/15/2019 |
| Опубліковано вперше: | 09/17/2019 |
| Останнє оновлення надіслано: | 10/10/2019 |
| Останнє оновлення опубліковано: | 10/13/2019 |
| Фактична дата початку навчання: | 02/11/2018 |
| Розрахункова дата первинного завершення: | 08/06/2019 |
| Розрахункова дата завершення дослідження: | 08/06/2019 |
Стан або захворювання
Втручання / лікування
Other: Placebo (Sodium Chloride)
Other: Exercise
Dietary Supplement: Sodium Propionate
Фаза
Групи рук
| Рука | Втручання / лікування |
|---|---|
| Placebo Comparator: Placebo + Fasting Sodium Chloride tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). | |
| Placebo Comparator: Placebo + Exercise Sodium Chloride tested in an exercise state. Participants will have the placebo then exercise will be performed at 40% of maximal aerobic capacity for one hour. | |
| Placebo Comparator: Placebo + Post-prandial Sodium Chloride tested in a post-prandial state. Participants will have the placebo then a mixed liquid meal test is given. | |
| Experimental: Propionate and Fasting Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). | |
| Experimental: Propionate and Exercise Sodium Propionate tested in an exercise state. Participants will have the sodium propionate then exercise will be performed at 40% of maximal aerobic capacity for one hour. | |
| Experimental: Propionate and Post-prandial Sodium Propionate tested in a post-prandial state. Participants will have the sodium propionate then a mixed liquid meal test is given. |
Критерії прийнятності
| Вік, придатний для навчання | 18 Years До 18 Years |
| Стать, яка підходить для вивчення | All |
| Приймає здорових добровольців | Так |
| Критерії | Inclusion Criteria: - Healthy volunteers (body mass index (BMI) of 18-35 kg/m2) - Age between 18-65 years (inclusive) Exclusion Criteria: - Weight change of ≥ 3kg in the preceding 2 months - Current smokers - Substance abuse - Excess alcohol intake - Pregnancy - Diabetes - Cardiovascular disease - Cancer - 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. |
Результат
Заходи первинного результату
1. Changes in Resting Energy Expenditure [6 hours]
2. Changes in Resting Lipid Oxidation [6 hours]
3. Changes in Energy Expenditure during Exercise [240 minutes]
4. Changes in Lipid Oxidation during Exercise [240 minutes]
5. Changes in Energy Expenditure post-prandially [300 minutes]
6. Changes in Lipid Oxidation post-prandially [300 minutes]
Заходи вторинного результату
1. Changes in GLP-1 Concentration [360, 240 and 300 minutes]
2. Changes in Insulin Concentration [360, 240 and 300 minutes]
3. Changes in glucose concentration [360, 240 and 300 minutes]
4. Changes in free fatty acid concentration [360, 240 and 300 minutes]
5. Changes in subjective nausea [360, 240 and 300 minutes]
6. Changes in subjective hunger [360, 240 and 300 minutes]
7. Changes in subjective thirst [360, 240 and 300 minutes]
