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临床试验/NCT02887950
NCT02887950终止不适用

Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Overweight Menopausal Women: a Pragmatic, Randomised Clinical Trial.

Fondazione IRCCS Policlinico San Matteo di Pavia2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

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

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

Active Comparator

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

Experimental

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

Experimental

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

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Riccardo Caccialanza

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (2)

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