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临床试验/NCT03322514
NCT03322514已完成不适用

Effect of Increased Colonic Propionate on Weight Loss During a Hypo-caloric Diet.

Imperial College London2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Change in Weight Loss Compared to Baseline

研究概览

简要总结

The current protocol aims to investigate the impact of the propionate ester in conjugation with restricted diet on appetite and weight loss.

详细描述

DIET AND OBESITY:

Obesity has reached epidemic proportions worldwide. In the United Kingdom, 58% of adult women and 65% of adult men are either overweight or obese (Health and Social Care Information Centre 2014), with the expectation that rates will increase (Ng et al. 2014). Obesity, mainly caused by a chronic positive energy balance, is a known risk factor that contributes to the development of type 2 diabetes and cardiovascular diseases, and the subsequent morbidities and mortalities (Kopelman 2007). A positive energy balance is inevitable with the composition of current western diet that contain refined (fibre-depleted) carbohydrates that are consumed quickly, and have minimal effects on long-term satiety (Cleave 1974; Heaton 1973).

NONDIGESTIBLE CARBOHYDRATES:

The quality and quantity of diet has changed dramatically over the last fifty years. Of which, carbohydrates have the most significant changes; from unprocessed fruits and vegetables based carbohydrates to more processed cereal based ones (Cordain et al. 2005). Epidemiological studies have shown that, as a result, ancestral diets had greater amounts of Non-Digestible Carbohydrates (NDC) than modern diets (>100g/day compared to <15g/day) with the inclusion of more indigestible intact cell wall plant material, such as tubers, grasses and sedges (Eaton 2006). A strong association has been established between increased weight gain with decreased NDC intake (Liu et al. 2003). Furthermore, increasing intake of NDC have shown to induce satiety and improve body composition in animals (So et al. 2007) and humans (Bouché et al. 2002).

LOW CALORIC HIGH NDC DIET IN LOSING WEIGHT Applying energy-restricted diets is one of the first steps to treat obesity. However, weight regain in weight maintenance period could happen due to resting energy expenditure reduction and lean mass loss. The inclusion of specific foods to the nutritional intervention is being investigated in order to produce persistent weight losses (Abete et al. 2008). It was suggested earlier that the addition of high fibre NDC foods to a hypocaloric diet would help reducing the incidence of metabolic syndrome and increasing the dietary compliance (Hermana et al, 2011). The high fibre content in combination with a low glycemic index diet, can both result in higher satiety effects with an increased mitochondrial oxidation, all favour weight loss.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • overweight or obese ((BMI) of 25-35 kg/m2)
  • aged between 18 and 65 years

排除标准

  • Weight change of ≥ 3kg in the preceding 2 months
  • Undergone any weight loss surgery or gastric procedures to promote weight loss
  • 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
  • Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
  • Any participants with the above conditions would already have an altered pattern of hormones and inflammatory molecules because of their disease process and would therefore give us confounding or misleading results.

结局指标

主要结局

Change in Weight Loss Compared to Baseline

时间窗: Baseline and 12 weeks

The weight assessed by a body scale

次要结局

  • Glucose Blood Level Baseline to 12 Weeks(Baseline, 12 weeks)
  • Insulin Level in Serum(Baseline, 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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