Plant Stanol Esters and COVID-19 Vaccination Response
2022年2月11日 更新者：Maastricht University Medical Center
The Effect of Plant Stanol Ester Consumption on the Vaccination Response to a COVID-19 Vaccine
Plant stanols are known to lower low-density lipoprotein cholesterol (LDL-C).
However, studies have suggested that these compounds also beneficially influence the immune system, e.g.
increasing vaccine-specific antibody titers.
BMI has previously been negatively associated to vaccination responses.
If plant stanols indeed have beneficial effect on the immune system, people with overweight or obesity might benefit from consuming plant stanols prior to receiving the COVID-19 vaccination.
The primary objective of this study is to demonstrate clinical benefits of consumption of plant stanols (delivered via products enriched with plant stanol esters) on the vaccination response to a COVID-19 vaccine in overweight or obese patients.
The main study endpoint is vaccination response to a COVID-19 vaccine.
Secondary endpoints include amongst others hematological, inflammatory and immunological parameters (e.g.
hs-CRP, leukocyte differential count) and metabolic markers (e.g.
blood lipid profiles, plasma glucose, serum insulin, HOMA-IR).
調査の概要
状態
終了しました
条件
研究の種類
介入
入学 (実際)
48
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
-
-
Limburg
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Maastricht、Limburg、オランダ、6229ER
- Maastricht University Medical Center
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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
18年歳以上 (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:
- Men and women
- Aged 18 years or older
- BMI between 27 and 35 kg/m2
- Currently not using products containing plant sterols or stanols (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
- Willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)
- Willing to keep the intake of fish oil and vitamin supplements constant
Exclusion Criteria:
- Already received COVID-19 vaccination
- Already had a positive test for COVID-19 (this includes all types of tests, e.g. PCR tests or antibody tests)
- Allergy to an ingredient of the mini drinks
- Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
- Pregnant women
- Breastfeeding women
- Excessive alcohol use (>20 consumptions per week)
- Regular use of soft or hard drugs
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：Plant stanol group
This arm receives 4g of plant stanols per day (delivered as plant stanol esters) by consuming mini drinks (100 mL each).
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Oat milk based mini drinks (100 mL) containing 2g plant stanols each (delivered as plant stanol esters).
First dose of one of the COVID-19 vaccines.
Participants have to wait until they are invited to receive the vaccine by the government; this study does not interfere with national planning of the vaccines.
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プラセボコンパレーター：Placebo group
This arm receives mini drinks without added plant stanols (delivered as plant stanol esters).
|
First dose of one of the COVID-19 vaccines.
Participants have to wait until they are invited to receive the vaccine by the government; this study does not interfere with national planning of the vaccines.
Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters).
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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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Vaccine specific antibody titers
時間枠：Change T=0 and T= 4 weeks
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The response to the COVID-19 vaccine will be measured by quantifying specific antibody titers (vaccine specific IgG and IgM).
These titers will be measured in blood samples collected weekly during the month after vaccination by suitable ELISAs.
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Change T=0 and T= 4 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 |
|---|---|---|
|
Immune parameters (1)
時間枠：T=-1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination
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Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
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T=-1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination
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Immune parameters (2)
時間枠：T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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hsCRP
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Leukocyte count
時間枠：T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Number of leukocytes measured in EDTA plasma
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Leukocyte differential count
時間枠：T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Number of subgroups of leukocytes measured in EDTA plasma
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Fasted metabolism (1)
時間枠：T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Serum non-cholesterol sterols and stanols
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Fasted metabolism (2)
時間枠：T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Serum lipid and lipoprotein profile
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
|
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Fasted metabolism (3)
時間枠：T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Glucose metabolism (including e.g.
plasma glucose, serum insulin and calculated HOMA-IR)
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Anthropometry (1)
時間枠：T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Body weight
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Anthropometry (2)
時間枠：T=-1 (start study)
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Height
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T=-1 (start study)
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Anthropometry (3)
時間枠：T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Waist circumference
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Anthropometry (4)
時間枠：T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Hip circumference
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Anthropometry (5)
時間枠：T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Waist-to-hip ratio
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T=-1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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Diet
時間枠：T=-1 (start study) and T=4 weeks after vaccination (end study)
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Food frequency questionnaire is used to determine if the participants maintain their habitual diet and to determine if the participants do not consume plant stanols and/or sterols outside the intervention
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T=-1 (start study) and T=4 weeks after vaccination (end study)
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Diary outcomes (1)
時間枠：T=-1 (start study) until T=4 weeks after vaccination (end of study)
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General illness
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T=-1 (start study) until T=4 weeks after vaccination (end of study)
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Diary outcomes (2)
時間枠：T=0 (day before vaccination) until T=4 weeks after vaccination (end of study)
|
Side effects COVID-19 vaccine
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T=0 (day before vaccination) until T=4 weeks after vaccination (end of study)
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Diary outcomes (3)
時間枠：T=-1 (start study) until T=4 weeks after vaccination (end of study)
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Medication intake
|
T=-1 (start study) until T=4 weeks after vaccination (end of study)
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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)
2021年4月22日
一次修了 (実際)
2022年1月11日
研究の完了 (実際)
2022年1月11日
試験登録日
最初に提出
2021年4月13日
QC基準を満たした最初の提出物
2021年4月13日
最初の投稿 (実際)
2021年4月14日
学習記録の更新
投稿された最後の更新 (実際)
2022年3月2日
QC基準を満たした最後の更新が送信されました
2022年2月11日
最終確認日
2022年2月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- METC 21-013
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
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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