The Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota (PREMIUM)

December 12, 2023 updated by: University of Alberta

The Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota: a 12-week Study in Individuals With Excessive Body Weight

This study will investigate the impact of a 12-week powdered meal replacement on inflammatory, metabolic, and hormonal markers of obesity-associated conditions and to correlate this response to compositional shifts within the gut microbiota. Moreover, resting energy expenditure, body composition, appetite sensations and soy metabolomics will be explored.

This study will be a randomized, parallel group, clinical trial of a 12-week nutritional intervention. A sample size of n=88 participants will be randomly allocated into one of the following groups:

  • Control group (CON): Participants will be asked to maintain their usual dietary intake over 12 weeks. Their usual dietary intake is expected to reflect the North American dietary pattern (i.e. ~15% of total energy intake coming from protein, ~50% from carbohydrate and ~35% from fat).
  • Powdered Meal Replacement group (PMR): Participants will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the meal replacement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake.

The following variables will be analyzed:

  • Interleukin (IL)-6.
  • Gut microbiota diversity and composition, specifically taxa that have been associated with health benefits, obesity, and weight loss.
  • Systemic inflammatory biomarkers (high-sensitivity C-reactive protein, IL-8, IL-10 and tumor necrosis factor-α);
  • Metabolic blood markers (glucose, insulin, lipid panel, peptide tyrosine-tyrosine, glucagon-like peptide-1, ghrelin, adiponectin, leptin, free glycerol, free fatty acids, and thyroid stimulating hormone)
  • Resting energy expenditure;
  • Body composition;
  • Appetite sensations (hunger, satiety, fullness, and prospective food consumption);
  • Soy polyphenols' metabolomics.
  • Gene expression and genetic polymorphisms. At baseline and after 6 and 12 weeks, individuals will attend our Human Nutrition Research Unit where all assessments will take place. In order to assess participants' adherence and follow-up, dietary intake, body weight and appetite sensations (only for participants assigned to the PMR group) will be assessed weekly during the 12-week intervention period. Additionally, participants will be contacted by phone weekly and reminded to maintain their journal/log.

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.

Detailed Description

Overweight and obesity increase the risk of developing several diseases having a negative effect on people's health. The prevalence of these conditions is increasing worldwide, but successful treatments are lacking. As excess body weight is a result of an imbalance between calories in and calories out, dietary intake plays an important role in maintaining a healthy body weight and overall health status. Meal replacements are nutritionally complete formula foods used to substitute a meal. They can be a drink, bar, or soup. These products have been gaining popularity because they can help individuals lose weight. In addition, depending on its ingredients, meal replacements may affect our health. For this reason, meal replacements have been studied for health benefits. However, how meal replacements affect the microbes living in our gut, inflammation, and our genes is not known. Well-designed studies using state-of-the-art equipment can help elucidate the mechanisms by meal replacements act in individuals with overweight or obesity.

The overall purpose of this research is to investigate the impact of a 12-week powdered meal replacement on inflammatory, metabolic, and hormonal markers of obesity-associated conditions and to correlate this response to compositional shifts within the gut microbiota. Moreover, resting energy expenditure, body composition, appetite sensations, soy metabolomics, gene expression, and genetic polymorphisms will be explored.

This study will be a randomized, parallel group, clinical trial of a 12-week nutritional intervention. A sample size of n=88 participants will be randomly allocated into one of the following groups:

  • Control group (CON): Participants will be asked to maintain their usual dietary intake over 12 weeks. Participants' usual dietary intake is expected to reflect the North American dietary pattern (i.e. ~15% of total energy intake coming from protein, ~50% from carbohydrate and ~35% from fat).
  • Powdered Meal Replacement group (PMR): Participants will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The amount of protein is considered higher than the North American dietary pattern (i.e. 15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).

The following variables will be analyzed:

  • Interleukin (IL)-6.
  • Gut microbiota diversity and composition, specifically taxa that have been associated with health benefits, obesity, and weight loss.
  • Systemic inflammatory biomarkers (high-sensitivity C-reactive protein [hs-CRP], IL-8, IL-10 and tumor necrosis factor-α [TNF-α]);
  • Metabolic blood markers [glucose, insulin, lipid panel (i.e. total cholesterol, LDL, HDL, and triglycerides), peptide tyrosine-tyrosine (PYY), glucagon-like peptide-1 (GLP-1), ghrelin, adiponectin, leptin, free glycerol, free fatty acids, and thyroid stimulating hormone (TSH)];
  • Resting energy expenditure;
  • Body composition;
  • Appetite sensations (hunger, satiety, fullness, and prospective food consumption);
  • Soy polyphenols' metabolomics.
  • Gene expression and genetic polymorphisms. At baseline and after 6 and 12 weeks, individuals will attend our Human Nutrition Research Unit where all assessments will take place. In order to assess participants' adherence and follow-up, dietary intake, body weight and appetite sensations will be assessed weekly during the 12-week intervention period. Additionally, participants will be contacted by phone weekly and reminded to maintain their journal/log. Dietary intake will be assessed by a 3-day dietary record (2 week days and 1 weekend day) at baseline, at mid-point and end of the study. Participants will also be asked to complete a 1-day dietary record on one weekday, each week of the study. The purpose of this regular assessment is to avoid daily fluctuations in eating patterns, also ensuring a personalized feedback for those experiencing weight fluctuations. Both of these assessments (i.e. 1-day and 3-day dietary records) will be conducted using the online Automated Self -Administered 24-hour Recall (ASA24) Canada. The ASA24 is a validated web-based program that uses the validated U.S. Department of Agriculture's Automated Multiple-Pass Method, and is modified to support the Canadian food supply.

Participants will receive a digital scale and will be asked to weight themselves daily. Participants from the PMR group will also be asked to rate their appetite sensations on a 100-mm VAS paper sheet. Appetite sensation should be completed in the morning (after waking up and while fasting) and 30 minutes after consuming the supplement snacks in order to assess hunger, satiety, fullness, and prospective food consumption.

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.
88

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Human Nutrition Research Unit

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Non-smoker;
  • Female/Male;
  • Aged 18 to 50 years;
  • Body mass index (BMI) between 25 and 37 kg/m²;
  • Weight stable (< ± 5 kg over past 6 months);
  • Fat mass ≥20% for men and ≥25% for women;
  • Maintaining current levels of physical activity throughout the study.
  • Female participants must verify use of acceptable, effective birth control methods (total abstinence, hormonal birth control [oral, injectable, transdermal, intravaginal], intrauterine devices, confirmed successful vasectomy or partner, or condoms).

Exclusion Criteria:

  • Diagnosis of chronic diseases or acute infections;
  • Taking any medication that may alter inflammation, energy metabolism, body weight and composition, gut microbiota and hormone levels; investigators should always be informed if there are any changes in medications or Natural health product use;
  • Taking pre- and probiotics (e.g. supplements);
  • Use of antibiotics in the past two months;
  • Use of thyroid replacement therapy;
  • Use of nutritional supplements in the past four weeks (multivitamin and vitamin D3 are permitted to be used during the course of the study);
  • Allergy to any ingredient (including non-medicinal ingredients) in investigational product;
  • Lactose, gluten and/or soy allergic/intolerant;
  • Follow a vegetarian, vegan or any restrictive dietary pattern;
  • Pregnant or lactating;
  • Perform over three hours of vigorous physical activity per week;
  • A nuclear medicine scan or injection of an X-ray dye in the past week;
  • A barium test/exam in the last two weeks;
  • Suffer from claustrophobia;
  • Inability to comprehend and complete the required questionnaires.

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 Assignment
  • Masking: None (Open Label)

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.
No Intervention: Control Group
Those assigned to the Control group will be asked to maintain their usual dietary intake over 12 weeks. Participants' usual dietary intake is expected to reflect the North American dietary pattern (i.e. ~15% of total energy intake coming from protein, ~50% from carbohydrate and ~35% from fat).
Experimental: Powdered Meal Replacement Group
Those assigned to the Powdered Meal Replacement group will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The amount of protein is considered higher than the North American dietary pattern (i.e. 15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).
Dietary supplement: Soy protein, honey and yogurt.
Participants will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The amount of protein is considered higher than the North American dietary pattern (i.e. 15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).

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
Interleukin-6.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in blood interleukin-6 will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 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
Gut microbiota diversity and composition.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in gut microbiome diversity and composition (specifically taxa that have been associated with health benefits, obesity and weight loss) will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 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
High-sensitivity C-reactive protein.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in blood high-sensitivity C-reactive protein will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Interleukin 8.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in interleukin 8 will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Interleukin 10.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in interleukin 10 will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Tumor necrosis factor-α.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in tumor necrosis factor-α will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Adiponectin.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in adiponectin will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Blood glucose.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in blood glucose will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Insulin.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in insulin will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Lipid panel.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides) will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Peptide tyrosine-tyrosine.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in peptide tyrosine-tyrosine will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Glucagon-like peptide 1.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in glucagon-like peptide-1 will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Ghrelin.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in ghrelin will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Leptin.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in leptin will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Free glycerol.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes free glycerol will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Free fatty acids.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in free fatty acids will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Thyroid stimulating hormone.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in thyroid stimulating hormone will be assessed at baseline, middle and end of the 12-week dietary intervention period.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Resting energy expenditure.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in resting energy expenditure will be assessed at baseline, middle and end of the 12-week dietary intervention period using a whole body calorimetry unit.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Body composition.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Changes in fat mass, lean soft tissue and bone mineral content will be assessed at baseline, middle and end of the 12-week dietary intervention period using dual-energy X-ray absorptiometry.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Appetite sensations.
Time Frame: Once per week during the intervention period (12 weeks).
Changes in hunger, satiety, fullness, and prospective food consumption will be assessed weekly using a 100 mm visual analogue scale.
Once per week during the intervention period (12 weeks).
Soy polyphenols' metabolomics.
Time Frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Soy polyphenols' metabolomics will be assessed on participants assigned to the 12-week dietary intervention periodPowdered Meal Replacement group at baseline, middle and end of the 12-week dietary intervention period using blood and urine samples.
At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
Gene expression
Time Frame: At baseline (week 1) and end (week 12) of the intervention period (12 weeks).
Changes in gene expression will be assessed at baseline and at the end of the 12-week dietary intervention period
At baseline (week 1) and end (week 12) of the intervention period (12 weeks).
Genetic polymorphisms
Time Frame: At baseline (week 1)
Genetic polymorphisms will be identified at baseline
At baseline (week 1)

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.
University of Alberta

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.
Almased Wellness GmbH

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: Carla M Prado, PhD, University of Alberta
  • Principal Investigator: Arya Sharma, PhD, University of Alberta
  • Principal Investigator: Jens Walter, PhD, University of Alberta

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.
April 1, 2019

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.
December 8, 2023

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.
December 8, 2023

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).
July 27, 2017

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.
July 31, 2017

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.
August 1, 2017

Study Record Updates

Last Update Posted (Estimated)

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.
December 14, 2023

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.
December 12, 2023

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.
December 1, 2023

More Information

Terms related to this study

Keywords

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.
  • Pro00070712

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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