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Food Supplement Effect on Overweight or Moderate Obesity (PHYTOENIX)

2022年12月13日 更新者:Jean-Michel Lecerf、Institut Pasteur de Lille

Effect of Carrot Seed and Rose Hip Extracts on Weight Management in Subjects With Overweight or Moderate Obesity. A Controlled, Randomized and Double-blind Study.

The aim of this study is to assess the effect of a food supplement containing extracts of carrot and rose hip seeds on the weight of volunteers with overweight or moderate obesity.

研究概览

研究类型

介入性

注册 (实际的)

129

阶段

  • 不适用

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

      • Paris、法国、75013
        • Institute of Cardiometabolism And Nutrition
    • Nord
      • Lille、Nord、法国、59019
        • NutrInvest - Institut Pasteur de Lille

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

20年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • BMI between 25 and 35 kg / m² (limits excluded),
  • Having a fat mass (measured by impedance balance in kg) according to the following table:

Men 18-29 years : ≥ 21.2 kg; Men 30-49 years : ≥ 21.6 kg; Men 50-65 years : ≥ 23.8 kg; Women 18-29 years : ≥ 31.4 kg; Women30-49 years : ≥ 31.8 kg; Women 50-65 years : ≥ 33.9 kg.

  • Willing to observe dietetic plan in accordance with dietitian evaluation,
  • Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
  • Affiliated with a social security scheme.

Exclusion Criteria:

  • Dyslipidemia or hyperlipidemia:

    • Fasting total cholesterol ≥ 3.0 g / L
    • Fasting triglycerides> 2.5 g / L
    • with heterozygous familial hypercholesterolemia,
  • Diabetes treated or not with medication,
  • With severe hepatic and / or renal impairment, liver enzyme level (ALT and / or AST) greater than 2.5 times the upper normal limit,
  • TSH abnormal or not stable for at least 3 months,
  • History of cardiac disease (heart attack, stroke, coronary artery disease) or chronic inflammatory disease in the previous 6 months,
  • With cancer or having had cancer in the 3 years preceding the study, with the exception of basal cell cancers of the skin,
  • Taking drugs known to have an impact on weight management (corticosteroids, neuroleptics, anti-HIV triple therapy, etc.) in the month preceding inclusion and / or likely to consume them during the test,
  • Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study,
  • Taking anti-depressant treatment or treatment related to anxiety Subject in a state of depression,
  • Weight loss treatment in the previous 6 months or having followed a specific treatment promoting weight loss,
  • Non stable weight during the last 6 months (>5% change in total weight),
  • With metal implant (to allow DEXA measurement),
  • Blood donation in the month before the start of the study and during the study,
  • Consuming food supplements or functional foods known to have an influence on weight management in the month preceding the inclusion and / or likely to take during the test,
  • Following or having followed a hypocaloric diet (energy intake <1,500 kCal / day) in the month preceding inclusion and / or likely to undertake this diet during the test,
  • Following a particular diet (vegan),
  • Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting),
  • Intense sport exercise practice (physical activity more than 4 hours per week) or not willing to maintain their exercise practises stable during the test,
  • Smoking more than 5 cigarettes per day, unstable cigarettes consumption, or smoking cessation during 6 months preceding the inclusion or during the test,
  • Bariatric surgery or who has a gastroplasty ring,
  • Consuming more than 2 (women) or 3 (men) standard drinks of alcoholic beverage daily,
  • Consuming illicit drugs,
  • Using topical anti-cellulite treatments,
  • For woman: Pregnant or planned to become, breastfeeding, with non-effective contraception,
  • Known allergy to one of the component of the supplement (carrot and rose hip),
  • Suffering from serious illnesses such as cancer, recent myocardial infarction, serious digestive pathologies or others diseases found to be inconsistent with the conduct of the study by the investigator,
  • Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
  • Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
  • Presenting a psychological or linguistic incapability to sign the informed consent,
  • Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.

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:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:High dose
4 capsules with 1.6g of active product per day: 2 at breakfast and 2 at dinner
Food supplements are consumed during 3 months by healthy volunteers.
有源比较器:Low dose
4 capsules with 0.8g of active product per day: 2 at breakfast and 2 at dinner
Food supplements are consumed during 3 months by healthy volunteers.
安慰剂比较:Maltodextrin
4 placebo capsules (maltodextrin) per day: 2 at breakfast and 2 at dinner
Food supplements are consumed during 3 months by healthy volunteers.

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
Change from Baseline weight at 3 months
大体时间:0 month (inclusion), 3 months
Weight (unit: kg)
0 month (inclusion), 3 months

次要结果测量

结果测量
措施说明
大体时间
Body mass composition by DEXA (dual energy x-ray absorptiometry)
大体时间:0 month (inclusion), 3 months
Lean body mass, total fat mass, subcutaneous fat mass, visceral fat mass (unit: g)
0 month (inclusion), 3 months
Anthropometric parameters
大体时间:0 month (inclusion), 1 month, 2 months, 3 months
Hip circumference, waist circumference and thigh circumference (unit: cm)
0 month (inclusion), 1 month, 2 months, 3 months
Fasting glycemia
大体时间:0 month (inclusion), 3 months
Carbohydrate metabolism: Fasting glycemia (unit: g/l)
0 month (inclusion), 3 months
Insulinemia
大体时间:0 month (inclusion), 3 months
Carbohydrate metabolism: Insulinemia (unit: mU/l)
0 month (inclusion), 3 months
HbA1c
大体时间:0 month (inclusion), 3 months
Carbohydrate metabolism: HbA1c (unit: percent)
0 month (inclusion), 3 months
HOMA index
大体时间:0 month (inclusion), 3 months
Carbohydrate metabolism: determination of the HOMA index (calculated)
0 month (inclusion), 3 months
Lipid metabolism
大体时间:0 month (inclusion), 3 months
Total cholesterol, HDL, LDL, Triglycerides (unit: g/l)
0 month (inclusion), 3 months
Free fatty acids
大体时间:0 month (inclusion), 3 months
Lipid metabolism: free fatty acids (unit: micromol/l)
0 month (inclusion), 3 months
Hepatic metabolism
大体时间:0 month (inclusion), 3 months
Creatinine (unit: mg/l)
0 month (inclusion), 3 months
Transaminases
大体时间:0 month (inclusion), 3 months
Hepatic metabolism: ASAT/ALAT (unit: UI/l)
0 month (inclusion), 3 months
Sedimentation rate
大体时间:0 month (inclusion), 3 months
Blood parameters: Sedimentation rate (unit: mm)
0 month (inclusion), 3 months
Blood count
大体时间:0 month (inclusion), 3 months
Blood parameters: Blood count (unit: G/L)
0 month (inclusion), 3 months
Thyroid Stimulating Hormone
大体时间:0 month (inclusion), 3 months
TSH (Thyroid Stimulating Hormone) (unit: mUI/l)
0 month (inclusion), 3 months
High sensible C-reactive protein
大体时间:0 month (inclusion), 3 months
CRPhs (high sensible C-reactive protein) (unit: mg/l)
0 month (inclusion), 3 months
Heart rate
大体时间:0 month (inclusion), 1 month, 2 months, 3 months
Hemodynamic parameters: Heart rate (unit: Pul/min)
0 month (inclusion), 1 month, 2 months, 3 months
Blood pressure
大体时间:0 month (inclusion), 1 month, 2 months, 3 months
Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg)
0 month (inclusion), 1 month, 2 months, 3 months
Body mass composition by impedancemetry
大体时间:0 month (inclusion), 1 month, 2 months, 3 months
Lean body mass and total fat mass (unit: percent)
0 month (inclusion), 1 month, 2 months, 3 months
Weight
大体时间:0 month (inclusion), 1 month, 2 months, 3 months
Anthropometric parameters: weight (unit: kg)
0 month (inclusion), 1 month, 2 months, 3 months
Height
大体时间:0 month (inclusion), 1 month, 2 months, 3 months
Anthropometric parameters: height (unit: cm)
0 month (inclusion), 1 month, 2 months, 3 months
Body Mass Index
大体时间:0 month (inclusion), 1 month, 2 months, 3 months
Anthropometric parameters: determined Body Mass Index (unit: kg/m²)
0 month (inclusion), 1 month, 2 months, 3 months

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。

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 (实际的)

2022年1月6日

初级完成 (实际的)

2022年10月31日

研究完成 (实际的)

2022年10月31日

研究注册日期

首次提交

2021年12月1日

首先提交符合 QC 标准的

2021年12月16日

首次发布 (实际的)

2022年1月5日

研究记录更新

最后更新发布 (实际的)

2022年12月16日

上次提交的符合 QC 标准的更新

2022年12月13日

最后验证

2022年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2021-A02422-39

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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