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.
調査の概要
研究の種類
介入
入学 (実際)
129
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Paris、フランス、75013
- Institute of Cardiometabolism And Nutrition
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Nord
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Lille、Nord、フランス、59019
- NutrInvest - Institut Pasteur de Lille
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年~65年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:High dose
4 capsules with 1.6g of active product per day: 2 at breakfast and 2 at dinner
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Food supplements are consumed during 3 months by healthy volunteers.
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アクティブコンパレータ:Low dose
4 capsules with 0.8g of active product per day: 2 at breakfast and 2 at dinner
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Food supplements are consumed during 3 months by healthy volunteers.
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プラセボコンパレーター:Maltodextrin
4 placebo capsules (maltodextrin) per day: 2 at breakfast and 2 at dinner
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Food supplements are consumed during 3 months by healthy volunteers.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change from Baseline weight at 3 months
時間枠:0 month (inclusion), 3 months
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Weight (unit: kg)
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0 month (inclusion), 3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Body mass composition by DEXA (dual energy x-ray absorptiometry)
時間枠:0 month (inclusion), 3 months
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Lean body mass, total fat mass, subcutaneous fat mass, visceral fat mass (unit: g)
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0 month (inclusion), 3 months
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Anthropometric parameters
時間枠:0 month (inclusion), 1 month, 2 months, 3 months
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Hip circumference, waist circumference and thigh circumference (unit: cm)
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0 month (inclusion), 1 month, 2 months, 3 months
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Fasting glycemia
時間枠:0 month (inclusion), 3 months
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Carbohydrate metabolism: Fasting glycemia (unit: g/l)
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0 month (inclusion), 3 months
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Insulinemia
時間枠:0 month (inclusion), 3 months
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Carbohydrate metabolism: Insulinemia (unit: mU/l)
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0 month (inclusion), 3 months
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HbA1c
時間枠:0 month (inclusion), 3 months
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Carbohydrate metabolism: HbA1c (unit: percent)
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0 month (inclusion), 3 months
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HOMA index
時間枠:0 month (inclusion), 3 months
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Carbohydrate metabolism: determination of the HOMA index (calculated)
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0 month (inclusion), 3 months
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Lipid metabolism
時間枠:0 month (inclusion), 3 months
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Total cholesterol, HDL, LDL, Triglycerides (unit: g/l)
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0 month (inclusion), 3 months
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Free fatty acids
時間枠:0 month (inclusion), 3 months
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Lipid metabolism: free fatty acids (unit: micromol/l)
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0 month (inclusion), 3 months
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Hepatic metabolism
時間枠:0 month (inclusion), 3 months
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Creatinine (unit: mg/l)
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0 month (inclusion), 3 months
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Transaminases
時間枠:0 month (inclusion), 3 months
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Hepatic metabolism: ASAT/ALAT (unit: UI/l)
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0 month (inclusion), 3 months
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Sedimentation rate
時間枠:0 month (inclusion), 3 months
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Blood parameters: Sedimentation rate (unit: mm)
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0 month (inclusion), 3 months
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Blood count
時間枠:0 month (inclusion), 3 months
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Blood parameters: Blood count (unit: G/L)
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0 month (inclusion), 3 months
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Thyroid Stimulating Hormone
時間枠:0 month (inclusion), 3 months
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TSH (Thyroid Stimulating Hormone) (unit: mUI/l)
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0 month (inclusion), 3 months
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High sensible C-reactive protein
時間枠:0 month (inclusion), 3 months
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CRPhs (high sensible C-reactive protein) (unit: mg/l)
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0 month (inclusion), 3 months
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Heart rate
時間枠:0 month (inclusion), 1 month, 2 months, 3 months
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Hemodynamic parameters: Heart rate (unit: Pul/min)
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0 month (inclusion), 1 month, 2 months, 3 months
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Blood pressure
時間枠:0 month (inclusion), 1 month, 2 months, 3 months
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Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg)
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0 month (inclusion), 1 month, 2 months, 3 months
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Body mass composition by impedancemetry
時間枠:0 month (inclusion), 1 month, 2 months, 3 months
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Lean body mass and total fat mass (unit: percent)
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0 month (inclusion), 1 month, 2 months, 3 months
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Weight
時間枠:0 month (inclusion), 1 month, 2 months, 3 months
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Anthropometric parameters: weight (unit: kg)
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0 month (inclusion), 1 month, 2 months, 3 months
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Height
時間枠:0 month (inclusion), 1 month, 2 months, 3 months
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Anthropometric parameters: height (unit: cm)
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0 month (inclusion), 1 month, 2 months, 3 months
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Body Mass Index
時間枠:0 month (inclusion), 1 month, 2 months, 3 months
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Anthropometric parameters: determined Body Mass Index (unit: kg/m²)
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0 month (inclusion), 1 month, 2 months, 3 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年1月6日
一次修了 (実際)
2022年10月31日
研究の完了 (実際)
2022年10月31日
試験登録日
最初に提出
2021年12月1日
QC基準を満たした最初の提出物
2021年12月16日
最初の投稿 (実際)
2022年1月5日
学習記録の更新
投稿された最後の更新 (実際)
2022年12月16日
QC基準を満たした最後の更新が送信されました
2022年12月13日
最終確認日
2022年12月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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