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Efficacy of a Whole Cell Algae Fermentate on Gut Health and Overall Immune Function in Healthy Adults With Mild Gastrointestinal Issues

2021年2月2日 更新者:Kemin Foods LC

A Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Efficacy of a Patented Whole Cell Algae Fermentate on Gut Health in Healthy Adults With Mild Gastrointestinal Issues

The objective of the current study is to evaluate the effect of whole cell fermentate on gut health, including GI system function, such as supporting consistency and regularity of bowel habits, as well as changes in microbiota. The role of the GI system can also be extended to immune regulation because approximately 70% of the entire immune system in the body is located around the gut. Thus, the health and wellbeing of the gut can have a great impact on whole-body health. Therefore, this study will assess the effect on overall immune function.

調査の概要

詳細な説明

This study is a randomized, placebo-controlled, crossover trial with a screening visit and two test periods separated by a three-week washout period.

At Visit 1, after subjects have provided informed consent, medical history will be reviewed and clinic visit procedures will be performed, including assessments of prior/current medication/supplement use, and evaluations of inclusion/exclusion criteria.Subjects will be dispensed a diet record, gastrointestinal questionnaire, bowel habits diary, upper respiratory symptom questionnaire, and a stool collection kit to complete prior to Visit 2 (week 0).

At Visit 2 (week 0), eligible subjects will return to the clinic. The stool samples will be collected, and the diet record, gastrointestinal questionnaire, and bowel habits diary will be collected. Subjects will also be administered a stress questionnaire and quality of life questionnaire. Eligible subjects will then be randomized to one of two test groups (placebo or active). Subjects will track study product intake using a daily study product log and track daily cold symptoms. Subjects will also be given a gastrointestinal questionnaire, bowel habits diary, upper respiratory symptom questionnaire, and a stool collection kit to complete prior to Visit 3 (week 4).

At Visit 3 (week 4), the stool samples will be collected, and the diet record, gastrointestinal questionnaire, and bowel habits diary will be collected. Subjects will also be administered a stress and quality of life questionnaire. Unused study product will be collected and compliance assessed via unused study product.Subjects will also be given a gastrointestinal questionnaire, bowel habits diary, and a stool collection kit to complete prior to Visit 4 (week 7)

Subjects will then enter the 3-week washout period, during which time no surveys/questionnaires will be kept and will then crossover to the other study product in their test sequence and repeat the Test Period I procedures (at Visit 2 and 3) during Test Period II (Visits 4 [week 7] and 5 [week 11]).

研究の種類

介入

入学 (実際)

70

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

    • Illinois
      • Addison、Illinois、アメリカ、60101
        • Biofortis Innovation Services

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

21年~60年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Subject is a male or female, 21-60 years of age
  2. Subject has a BMI of 18.5-34.9 kg/m2
  3. Subject reports having mild GI issues
  4. Subject is willing and able to comply with the collection and storage requirements of the stool samples
  5. Subject has internet access via computer, phone or other device and is able to maintain internet access throughout the trial in order to complete online daily questionnaires
  6. Subject is a non-user of all tobacco, smoking products and nicotine products
  7. Subject is willing to maintain physical activity patterns, body weight, supplements/medications, sleep patterns, and habitual diet throughout the trial.
  8. Subject has no health conditions that would prevent him from fulfilling the study requirements 9 Subject understands the study procedures and signs forms providing informed consent to participate in the study

Exclusion Criteria:

  1. Subject has an abnormal laboratory test result(s) of clinical importance at Visit 1
  2. Subject has a clinically important GI condition that would potentially interfere with the evaluation of the study product
  3. Subject has a history or presence of uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including type 1 and type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including unstable depression and/or unstable anxiety disorders) or biliary disorders
  4. Subject has a known allergy, intolerance, or sensitivity to any of the ingredients in the study products
  5. Subject has extreme dietary habits (e.g., Atkins diet, very high protein, very high fiber)
  6. Subject has uncontrolled hypertension
  7. Subject has a recent (within 6 weeks of Visit 1) diarrhea (defined as ≥3 loose or liquid stools/d)
  8. Subject has participated in colonoscopy or colonoscopy preparation within 3 months prior to Visit 1
  9. Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer
  10. Subject has a history of bariatric surgery for weight reducing purposes
  11. Subject has had a weight gain or loss of ≥5% body weight within 6 months of Visit 1
  12. Subject has experienced any major trauma or any other surgical event within three months of Visit 1
  13. Subject has any signs or symptoms of an active infection (including diarrhea) of clinical relevance within 5 days of Visit 1
  14. Subject has used antibiotics within 3 months of Visit 1 or throughout study period
  15. Subject has used medications (over-the-counter or prescription) or dietary supplements known to influence GI function
  16. Subject has used medications or supplements known to influence immune responses
  17. Subject is a regular user (>3 times/week) of prescribed anti-inflammatory medications within 30 d of Visit 1
  18. Subject is a regular user (i.e., >1 time per month) of allergy medications
  19. Subject has used weight-loss medications
  20. Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period
  21. Subject has a recent history of (within 12 months of screening; Visit 1; week -1) or strong potential for alcohol or substance abuse
  22. Individual has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk

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:ヘルスサービス研究
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター:Placebo
Microcystalline Cellulose
微結晶性セルロース
実験的:Treatment
Whole Cell Algae Fermentate
Contains at minimum 50% Beta Glucan

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
Gastrointestinal symptom
時間枠:After 4 weeks of each test period
Gastrointestinal Tolerability Questionnaire
After 4 weeks of each test period
Gastrointestinal ease and consistency
時間枠:After 4 weeks of each test period
Bristol Stool Scale
After 4 weeks of each test period
Cold/Flu Symptoms
時間枠:After 4 weeks of each test period
Wisconsin Upper Respiratory Symptom Survey
After 4 weeks of each test period

二次結果の測定

結果測定
メジャーの説明
時間枠
Fecal Microbiome
時間枠:After 4 weeks of each test period
Omnigene-GUT DNA Genotek
After 4 weeks of each test period
Fecal biomarker 1
時間枠:After 4 weeks of each test period
Short Chain Fatty Acid
After 4 weeks of each test period
Fecal biomarker 2
時間枠:After 4 weeks of each test period
Leaky Gut biomarker
After 4 weeks of each test period
Stress Questionnaire
時間枠:After 4 weeks of each test period
Perceived Stress Questionnaire
After 4 weeks of each test period
Quality of Life Questionnaire
時間枠:After 4 weeks of each test period
World Health Organization-Quality of Life Questionnaire
After 4 weeks of each test period

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。

スポンサー

捜査官

  • 主任研究者:Andrea Lawless, MD、Biofortis Innovation Services

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)

2019年3月21日

一次修了 (実際)

2019年12月20日

研究の完了 (実際)

2020年6月20日

試験登録日

最初に提出

2019年3月27日

QC基準を満たした最初の提出物

2021年2月2日

最初の投稿 (実際)

2021年2月3日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月3日

QC基準を満たした最後の更新が送信されました

2021年2月2日

最終確認日

2019年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • BIO-1901

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

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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