過体重または肥満の人における次世代シンバイオティクス
過体重または肥満の人への次世代シンバイオティクスの補給: 三重盲検ランダム化対照臨床試験
This study plans to evaluate the effect of consuming a symbiotic (probiotic + prebiotic) for 3 months on body weight, body composition, glucose sensitivity, and psychological parameters, as well as on gut and blood microbial composition. Synbiotic consumption is preceded by a 3-day antibiotic course to help ensure the opening of new niches (houses) for the upcoming beneficial bacteria.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
This is a triple-blinded, randomized clinical trial in which participants will be allocated to one of two groups: 1) 3-day antibiotic followed by synbiotic consumption for 3 months or 2) 3-day antibiotic followed by placebo consumption for 3 months.
Blood and stool samples will be collected before the antibiotic, and before and after the symbiotic intervention in both groups.
Gut microbial composition will be analyzed through whole genome sequencing and blood microbial composition through 16S rRNA.
Glucose sensitivity will be measured through fasting glucose, fasting insulin, and HbA1c.
Body composition through DXA and BodPod will be measured before and after the symbiotic intervention.
Psychological questionnaires such as the Beck Anxiety and the Beck Depression Inventories, as well as the RED-9 questionnaire to respectively measure anxiety, depression, and food cravings, will be applied before and after the symbiotic intervention.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Fort Worth、Texas、アメリカ、76129
- Texas Christian University, Rickel Building
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参加基準
適格基準
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:
- be between 18-50 years of age
- have a BMI between 25.0-40.0
Exclusion Criteria:
- are following a vegetarian, vegan, carnivore, or keto diet
- currently taking metformin, GLP-1 agonists, insulin, or fiber
- have taken antiacids, laxatives, probiotics, or medication that affects your immune system in the past month
- pregnant, planning pregnancy during the study period, or lactating
- have a history of inflammatory bowel disease, colon cancer, or chronic polyps
- have been diagnosed with type 1 or type 2 diabetes
- have active cancer
- are currently participating in a weight loss intervention (dietetic or medication)
- have used antibiotics, antifungals, or antivirals in the past 3 months
- have had a history of recent (within 30 days) diarrhea illness
- have a known allergy to any component of the study product
- have had an acute inflammatory infection or inflammatory condition in the past 4 weeks
- have had >10% weight variation in the past 6 months
- have had any bariatric surgery
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：4倍
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
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実験的：Synbiotic Group
They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month symbiotic. The synbiotic that will be used in this trial contains the oligosaccharide-degrading probiotics, Akkermansia muciniphila and Bifidobacterium infantis; butyrate producers such as Clostridium beijerinckii, Anaerobutyricum hallii, and Clostridium butyricum; and chicory-derived inulin, a prebiotic dietary fiber. |
WBF-038: Noninfectious and nonhazardous lyophilized commensal bacteria (probiotics). Contains no genetically modified organisms (GMOs) and contains no animal ingredients or by-products, and were originally isolated from human sources. The (probiotic) strains are grown in a FDA registered food facility, adhering to Good Manufacturing Practice (GMP) conditions. Probiotic Ingredients: Clostridium butyricum WBSTR-0006, Clostridium beijerinckii WB-STR-0005, Anaerobutyricum hallii WB-STR-0008, Akkermansia muciniphila WBSTR-0001, and Bifidobacterium infantis The product also contains: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit & vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation)
他の名前：
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プラセボコンパレーター：Placebo Group
They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month placebo. |
Ingredients: Chicory inulin and oligofructose (prebiotic fiber, hypromellose (vegetarian capsule), fruit & vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation).
他の名前：
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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
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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Total Body Fat Mass through DXA (percentage)
時間枠：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body fat mass by using DXA analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Total Body Fat Mass through BodPod (percentage)
時間枠：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body fat mass by using BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fat Mass to Height (kg/m2)
時間枠：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body fat mass by using DXA analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fat Mass (kg)
時間枠：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body fat mass by using BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Body Lean Mass to Height (kg/m2)
時間枠：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body lean mass by using DXA analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fat Free Mass (%)
時間枠：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body lean mass by using BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fat Free Mass (Kg)
時間枠：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body lean mass by using BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Visceral Fat Volume (cm3)
時間枠：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body visceral mass by using DXA and BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Visceral Fat Mass (grams)
時間枠：These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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We will measure body visceral mass by using DXA and BodPod analysis. |
These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
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Fasting Glucose (mg/dL)
時間枠：Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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We will measure fasting glucose after a 12h fast. |
Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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Fasting Insulin (mIU/L)
時間枠：Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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We will measure fasting insulin after a 12h fast. |
Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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HbA1c (%)
時間枠：Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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We will measure HbA1c after a 12h fast. |
Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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Anxiety (number in 0-63 scale)
時間枠：These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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We will measure anxiety by using the Beck Anxiety inventory. The higher the number, the higher the anxiety levels. |
These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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Depression (number in 0-63 scale)
時間枠：These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
|
We will measure depression by using the Beck Depression inventory. The higher the number, the higher the depression. |
These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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Food cravings (number in 0-52 scale)
時間枠：These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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We will measure food cravings by using the Reward-based Eating Drive questionnaire (RED-9). The higher the number, the higher the cravings. |
These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
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Gut Microbial Composition (depending on funding availability at the time of analysis)
時間枠：Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
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We plan to measure gut microbial composition by performing whole metagenome sequencing previously stored in Zymo stool collection tubes. |
Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
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Blood Microbial Composition (depending on funding availability at the time of analysis)
時間枠：Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
|
We plan to measure blood microbial composition by performing 16S rRNA in blood samples previously stored in Zymo blood collection tubes. |
Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
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Body Weight (kg)
時間枠：Measurements will take place at each of the 3 visits: right before the antibiotic, right before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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Body weight will be measured with a calibrated scale. |
Measurements will take place at each of the 3 visits: right before the antibiotic, right before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
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Body Height (meters)
時間枠：Measurement will take place at the first visit.
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Body height will be measured with a stadiometer. |
Measurement will take place at the first visit.
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協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Elisa Marroquin, Ph.D.、Texas Christian University
出版物と役立つリンク
一般刊行物
- Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019 Jul;25(7):1096-1103. doi: 10.1038/s41591-019-0495-2. Epub 2019 Jul 1.
- Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- 2023-345
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
De-identified participant-level data can be shared only after authors and co-authors have published the material of their interest.
IPD 共有時間枠
Data will be available only after authors and co-authors have published the material of their interest.
IPD 共有アクセス基準
Not available at this point. Recruitment has not started.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。