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Functional Bioactive Supplement Effect in Lost Weight Treatment (ALIBIRDII)

A Randomized, Double-blind Trial to Evaluate the Effect of a Functional Bioactive Supplement Associated With a Hypocaloric Equilibrated Diet to Treatment of Obese and Overweight Individuals

The purpose this study is to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treat obese and overweight individuals. The functional bioactive supplement, containing antioxidant extracted from rosemary, oligosaccharides derived from lactulose and bioactive peptides, was developed to satiety control, improves of anti-inflammatory response and antioxidant defense mechanisms as well as to weight loss.

研究概览

详细说明

A randomized, parallel, double-blind, controlled was performed to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treatment of obesity and overweight.

Women aged between 18 and 65 years with obesity and overweight diagnosis (IMC >25<35 kg/m2) were included in the study. The clinical trial will be performed in the Clinical Nutrition Department of La Paz University Hospital, in Madrid. All of the volunteers will receive a dietetic treatment with 1500 Kcal/day and physical activity recommendations during the study.

研究类型

介入性

注册 (实际的)

109

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Madrid、西班牙、28061
        • Hospital Universitario La Paz

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Women from 45 to 75 years old;
  • Overweight (IMC ≥25<30 Kg/m2) or obese (IMC ≥30<35 Kg/m2) volunteers
  • Signed informed consent.

Exclusion Criteria:

  • Subjects with drug consumption (lipid-lowering, oral hypoglycemic agents and / or hypertensive) in less than one month period;
  • Subjects with Diabetes Mellitus insulin dependent;
  • Individuals that stop smoking in the next 12 weeks (during the study);
  • Subjects with increased alcohol consumption (> 1 glass of vine);
  • Subjects that consume drugs, vitamins, minerals, prebiotics or/and probiotics that interfere with the body's response to the extracts in the 2 weeks before to baseline;
  • Subjects with drugs consumption special diet due to disease as celiac disease, chronic renal failure, etc;
  • Subjects with disorders associated with eating behaviour;
  • Subjects with drugs or supplements consumption to weight lost;
  • Subjects with physical problems complying with the recommendations of physical activity and diet indicated;
  • Subjects who refuse to perform the indicated dietary changes throughout the study;
  • Subjects with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.);
  • Subjects with mental disease or low cognitive function;
  • Subjects with severe diseases (hepatic, kidney, cancer…);
  • Pregnant women or lactating;
  • Subjects with physical problems complying with the recommendations of physical activity.
  • Subjects with intensive physical activity;

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Functional bioactive supplement
The functional bioactive supplement is composed of antioxidant extracted from rosemary, oligosaccharides derived from lactulose and bioactive peptides. It will be used for obese and overweight treatment
1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
其他名称:
  • antioxidant, oligosaccharides and bioactive peptides
安慰剂比较:Maltodextrin and saccharose
The control supplement is composed of maltodextrin and saccharose . It has no effect for obese and overweight treatment

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Changes in body composition
大体时间:12 weeks
Clinical response - changes in body composition: weight, waist circumference and Absorptiometry, Dual X-Ray.The primary outcome result measurement was the lost weight, changes in body composition
12 weeks

次要结果测量

结果测量
措施说明
大体时间
Life style and health status: Life style and physical activity questionnaire
大体时间:Week 0 and Week 12
Week 0 and Week 12
Genetic analysis
大体时间:Week 0 and Week 12
Week 0 and Week 12
Metabolomic analyses
大体时间:Week 0 and Week 12
Week 0 and Week 12
Endothelial function markers
大体时间:Week 0 y Week 12
Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
Week 0 y Week 12
Satiety hormones
大体时间:Week 0 y Week 12
Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
Week 0 y Week 12
Inflammatory markers
大体时间:Week 0 and Week 12
Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
Week 0 and Week 12
Glucose Metabolism
大体时间:Week 0 and Week 12
Glucose Metabolism: glucose, basal insulin, HbA1c (in diabetic patients), HOMA index (glycemic insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5)
Week 0 and Week 12
Lipid profile: Cholesterol
大体时间:Week 0 and Week 12
Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
Week 0 and Week 12
Oxidative Stress Parameters
大体时间:Week 0 and Week 12
Oxidative Stress Parameters: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power) and lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay), oxidized LDL, PON1, F2-isoprostanes
Week 0 and Week 12
Adverse effects
大体时间:0 , 3, 6, 9 and 12 weeks
Adverse effects: transaminases and creatinine
0 , 3, 6, 9 and 12 weeks

其他结果措施

结果测量
措施说明
大体时间
Appetite and satiety
大体时间:0 , 3, 6, 9 and 12 weeks
0 , 3, 6, 9 and 12 weeks
Frequent daily evacuations
大体时间:4 Weeks
Frequent daily evacuations, format and consistency of the feces, total and segmental transit time. The format and consistency of the feces was evaluated in accordance with the Bristol Stool Form Scale (stool are rated based on water content of the feces, with 1 meaning hard stools to 7 meaning liquid stools)
4 Weeks
Adherence and Tolerance Parameters
大体时间:0 , 3, 6, 9 and 12 weeks
Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed
0 , 3, 6, 9 and 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Carmen Gomez Candela, PhD、Hospital Universitario La Paz

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年9月1日

初级完成 (实际的)

2013年12月1日

研究完成 (实际的)

2014年1月1日

研究注册日期

首次提交

2013年12月27日

首先提交符合 QC 标准的

2013年12月27日

首次发布 (估计)

2013年12月31日

研究记录更新

最后更新发布 (估计)

2015年11月20日

上次提交的符合 QC 标准的更新

2015年11月18日

最后验证

2015年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Functional bioactive supplement的临床试验

3
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