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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Madrid、スペイン、28061
- Hospital Universitario La Paz
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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;
研究計画
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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ: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
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1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
他の名前:
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プラセボコンパレーター:Maltodextrin and saccharose
The control supplement is composed of maltodextrin and saccharose .
It has no effect for obese and overweight treatment
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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 |
---|---|---|
Changes in body composition
時間枠:12 weeks
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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
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12 weeks
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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 |
---|---|---|
Life style and health status: Life style and physical activity questionnaire
時間枠:Week 0 and Week 12
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Week 0 and Week 12
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Genetic analysis
時間枠:Week 0 and Week 12
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Week 0 and Week 12
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Metabolomic analyses
時間枠:Week 0 and Week 12
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Week 0 and Week 12
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Endothelial function markers
時間枠:Week 0 y Week 12
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Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
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Week 0 y Week 12
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Satiety hormones
時間枠:Week 0 y Week 12
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Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
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Week 0 y Week 12
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Inflammatory markers
時間枠:Week 0 and Week 12
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Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
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Week 0 and Week 12
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Glucose Metabolism
時間枠:Week 0 and Week 12
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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)
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Week 0 and Week 12
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Lipid profile: Cholesterol
時間枠:Week 0 and Week 12
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Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
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Week 0 and Week 12
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Oxidative Stress Parameters
時間枠:Week 0 and Week 12
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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
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Week 0 and Week 12
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Adverse effects
時間枠:0 , 3, 6, 9 and 12 weeks
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Adverse effects: transaminases and creatinine
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0 , 3, 6, 9 and 12 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Appetite and satiety
時間枠:0 , 3, 6, 9 and 12 weeks
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0 , 3, 6, 9 and 12 weeks
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Frequent daily evacuations
時間枠:4 Weeks
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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)
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4 Weeks
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Adherence and Tolerance Parameters
時間枠:0 , 3, 6, 9 and 12 weeks
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Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed
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0 , 3, 6, 9 and 12 weeks
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協力者と研究者
捜査官
- 主任研究者:Carmen Gomez Candela, PhD、Hospital Universitario La Paz
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- ALIBIRDII
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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