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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

2 de febrero de 2021 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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]).

Tipo de estudio

Intervencionista

Inscripción (Actual)

70

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Illinois
      • Addison, Illinois, Estados Unidos, 60101
        • Biofortis Innovation Services

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años a 60 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Microcystalline Cellulose
celulosa microcristalina
Experimental: Treatment
Whole Cell Algae Fermentate
Contains at minimum 50% Beta Glucan

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gastrointestinal symptom
Periodo de tiempo: After 4 weeks of each test period
Gastrointestinal Tolerability Questionnaire
After 4 weeks of each test period
Gastrointestinal ease and consistency
Periodo de tiempo: After 4 weeks of each test period
Bristol Stool Scale
After 4 weeks of each test period
Cold/Flu Symptoms
Periodo de tiempo: After 4 weeks of each test period
Wisconsin Upper Respiratory Symptom Survey
After 4 weeks of each test period

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fecal Microbiome
Periodo de tiempo: After 4 weeks of each test period
Omnigene-GUT DNA Genotek
After 4 weeks of each test period
Fecal biomarker 1
Periodo de tiempo: After 4 weeks of each test period
Short Chain Fatty Acid
After 4 weeks of each test period
Fecal biomarker 2
Periodo de tiempo: After 4 weeks of each test period
Leaky Gut biomarker
After 4 weeks of each test period
Stress Questionnaire
Periodo de tiempo: After 4 weeks of each test period
Perceived Stress Questionnaire
After 4 weeks of each test period
Quality of Life Questionnaire
Periodo de tiempo: After 4 weeks of each test period
World Health Organization-Quality of Life Questionnaire
After 4 weeks of each test period

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Andrea Lawless, MD, Biofortis Innovation Services

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

21 de marzo de 2019

Finalización primaria (Actual)

20 de diciembre de 2019

Finalización del estudio (Actual)

20 de junio de 2020

Fechas de registro del estudio

Enviado por primera vez

27 de marzo de 2019

Primero enviado que cumplió con los criterios de control de calidad

2 de febrero de 2021

Publicado por primera vez (Actual)

3 de febrero de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de febrero de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

2 de febrero de 2021

Última verificación

1 de marzo de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • BIO-1901

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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