Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Overweight Menopausal Women: a Pragmatic, Randomised Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
For women aged between 55 and 65 years weight gain is a major health concern. Obesity is an important risk factor for multiple diseases (e.g. metabolic syndrome, diabetes mellitus, hypertension and cardiovascular disease), and several studies have shown that the transition to menopause is associated with adverse changes in body composition. In particular, it is common to observe the accumulation of adipose tissue in the abdominal region which is believed to be an important determinant of the increase in cardiovascular risk.
The first-line strategy for weight management in overweight / obese subjects is the modification of dietary habits and lifestyle in terms of physical activity. However, nowadays, there is also a growing interest in complementary therapies (i.e. herbal supplements, acupuncture, etc ...) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as resistant starch, epigallocatechin gallate and chlorogenic acid as adjuvants of dietary therapy for overweight.
These nutrients may be an important therapeutic aid for overweight subjects. However, in support of their use, the evidence from good quality trials is limited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •menopause of recent onset
- •overweight (body mass index ≥ 25) or weight gain ≥ 10% after menopause
- •written informed consent
排除标准
- •use of Orlistat
- •cancer diagnosis
- •unavailability to planned measurements
研究组 & 干预措施
Nutritional counseling
Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.
干预措施: Nutritional counseling (Other)
Equikilon-3 months
The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 3 months and nutritional counseling.
Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.
干预措施: Equikilon-3 months (Dietary Supplement)
Equikilon-6 months
The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 6 months and nutritional counseling.
Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.
干预措施: Equikilon-6 months (Dietary Supplement)
结局指标
主要结局
Body weight
时间窗: 3 months
Difference in change in body weight between patients receiving the experimental product and those not assigned to its use
次要结局
- Quality of life(6 months)
- Visceral adiposity(6 months)
- Fat free mass(6 months)
- Menopausal symptoms(6 months)
- Insulin resistance(6 months)
- Body weight(6 months)
- LDL cholesterol(6 months)
- Triglycerides(6 months)
研究者
Riccardo Caccialanza
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
