Effect of Nutrition Ingredients on Microbiota Modulation (VitaGut)

March 27, 2020 updated by: DSM Nutritional Products, Inc.

A Randomized, Double-blinded, Parallel, Placebo-controlled Pilot Study to Investigate the Effect of Nutrition Ingredients on Microbiota Composition in Healthy Adults

The objective of this study is to evaluate in healthy volunteers the time-dependent effect of daily consumption for four weeks of six different nutrition ingredients on relative abundance of microbial taxa in fecal samples. Second, the study looks at the time-dependent effect of six different nutrition ingredients on alpha and beta diversity of microbiota in fecal samples. Moreover, the time-dependent effect of six different nutrition ingredients on gastrointestinal symptoms and quality of life will be measured.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Blackpool Cork
      • Cork, Blackpool Cork, Ireland, T12HH60
        • Atlantia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects willing and able to give written informed consent and to understand, to participate and to comply with the clinical study requirements;
  2. Be between 20 and 50 years of age;
  3. Has a BMI of between 18.5 - 30 Kg/m2;
  4. Has a stable body weight (< 5% change) over the past 3-months;
  5. Is in general good health, as determined by the investigator;
  6. Willing to avoid consuming dietary supplements, prebiotic, probiotic, dietary or fibre rich supplements within 4 weeks prior to baseline visit, until the end of the study;
  7. Willing to avoid liver consumption during the intervention
  8. Maintain current level of physical activity;
  9. Women of child-bearing potential using a non-hormonal contraceptive (e.g. IUD);
  10. Willing to consume the investigational product daily for the duration of the study.

Exclusion Criteria:

  1. Females are pregnant, lactating or wish to become pregnant during the study.
  2. Are hypersensitive to any of the components of the test product;
  3. Has taken antibiotics within the previous 3 months;
  4. Has a history of drug and/or alcohol abuse at the time of enrolment;
  5. Consumes greater than 2 servings/day of alcohol (e.g. >28 g ethanol/day);
  6. Is a smoker;
  7. Has made any major dietary changes in the past 3 months;
  8. Subject is planning a sun or ski holiday over the duration of the study;
  9. Planned major changes in life style (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
  10. Has an eating disorder;
  11. Is vegetarian/vegan diet or has food allergies or other issues with foods that would preclude intake of the study products;
  12. Is using fibre supplements or enemas;
  13. Has a high fiber diet (i.e. >30 g) based on FFQ;
  14. Has an active gastrointestinal disorder or previous gastrointestinal surgery,
  15. If taking chronic medications (e.g., anti-hypertensive medications), they must have been taking the product for at least two months prior to screening and agree to maintain the same dosage throughout the study;
  16. Has a metabolic, psychiatric, or gastrointestinal disease (i.e., diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, diabetes, hepatitis, HIV, cancer, etc.), with a history of such diseases;
  17. Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year);
  18. Experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (<3 months) or abdominal pain;
  19. Have a malignant disease or any concomitant end-stage organ disease;
  20. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
  21. Subjects may not be receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Vitamin B2
Daily dose of 75 mg Vitamin B2
Dietary supplement: Vitamin B2
One capsule of 75 mg Vitamin B2 once a day for 4 weeks
Other Names:
  • Riboflavin
EXPERIMENTAL: Vitamin C
Daily dose of 500 mg Vitamin C
Dietary supplement: Vitamin C
One capsule of 500 mg Vitamin C once a day for 4 weeks
EXPERIMENTAL: Vitamin B2 + C
Daily dose of 75 mg Vitamin B2 and 500 mg Vitamin C
Dietary supplement: Vitamin B2 + C
One capsule of of 75 mg Vitamin B2 plus 500 mg Vitamin C once a day for 4 weeks
EXPERIMENTAL: Vitamin A
Daily dose of 250 µg Vitamin A
Dietary supplement: Vitamin A
One capsule of 250 µg Vitamin A once a day for 4 weeks
EXPERIMENTAL: Vitamin D3
Daily dose of 60 µg Vitamin D3
Dietary supplement: Vitamin D3
One capsule of 60 µg Vitamin D3 once a day for 4 weeks
Other Names:
  • Cholecalciferol
EXPERIMENTAL: Vitamin E
Daily dose of 100 mg Vitamin E
Dietary supplement: Vitamin E
One capsule of 100 mg Vitamin E once a day for 4 weeks
Other Names:
  • alpha-tocopherol
PLACEBO_COMPARATOR: Placebo
Daily dose of 575 mg microcrystalline cellulose
Dietary supplement: Placebo
One capsule of 575 mg microcrystalline cellulose once a day for 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Time Frame: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of relative abundance of microbial taxa (operational taxonomic units)
from baseline to 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Alpha diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Time Frame: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of alpha diversity assessed with shotgun sequencing (Shannon diversity, Estimated ChaoI index)
from baseline to 4 weeks
Beta diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing
Time Frame: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of beta diversity assessed with shotgun sequencing (bray-curtis distance metrics)
from baseline to 4 weeks
Short-chain fatty acids concentrations in fecal samples
Time Frame: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of short-chain fatty acids using GC-MS (mM)
from baseline to 4 weeks
Ammonia concentrations in fecal samples
Time Frame: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of ammonia concentrations assessed with phenol-hypochlorite method (mg/L)
from baseline to 4 weeks
Cytokines and chemokines in blood
Time Frame: from baseline to 4 weeks
Changes from baseline in the treatment group as compared to placebo of cytokines and chemokines using immune assays (pg/mL)
from baseline to 4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Electronic Gastrointestinal Symptom Rating Scale (GSRS) questionnaire
Time Frame: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of the GSRS. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms
from baseline to 4 weeks
Short Form 36 (SF-36) questionnaire
Time Frame: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of the quality of life questionnaire Short Form 36 (SF-36) questionnaire. The Short Form (SF)-36 generates a profile of health-related quality of life outcomes by measuring health across eight different dimensions: physical functioning, role limitation because of physical health, social functioning, vitality, bodily pain, mental health, role limitation because of emotional problems and general health. Responses to each question within a dimension are combined to generate a score from 0 to 100; where 100 indicates "good health".
from baseline to 4 weeks
Volatile organic compound levels in fecal samples
Time Frame: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of volatile organic compounds (intensity)
from baseline to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DSM Nutritional Products, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Atlantia Food Clinical Trials

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timothy Dinan, Prof, Cork University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-12-19-VIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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