PRebiotic to IMprovE Calcium Absorption (PRIME)

October 20, 2020 updated by: Anne Schafer, San Francisco Veterans Affairs Medical Center

Prebiotic Intervention to Improve Calcium Absorption After Gastric Bypass Surgery

Gastric bypass surgery is a highly effective treatment for obesity, but it has negative effects on skeletal health, due in part to a dramatic decline in intestinal calcium absorption capacity. Animal and human studies suggest that non-digestible fibers termed prebiotics, such as soluble corn fiber (SCF), augment calcium absorption in the lower intestine as they act as substrates for beneficial gut microbiota. This is a pilot randomized controlled trial of the effects of SCF vs. placebo on intestinal calcium absorption, bone turnover marker levels, and the gut microbiome in postmenopausal women who have previously undergone gastric bypass surgery.

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

The study is a pilot randomized control trial (RCT) of the effects of the prebiotic SCF vs. placebo in 20 postmenopausal women who underwent Roux-en-Y gastric bypass surgery 2-6 years previously and thus have completed the postoperative period of rapid weight loss and metabolic and dietary change. A 24 g/day dose of SCF85 (which is approximately 20 g/day fiber) will be tested, as that dose was proven effective for calcium absorption/retention in healthy postmenopausal women and adolescents. The SCF and the maltodextrin placebo will be mixed in water and consumed in divided doses twice daily for 2 months, a duration exceeding other SCF trials but remaining feasible for a pilot. The primary outcome will be change in intestinal calcium absorption, which is the efficacy outcome about which the study must collect preliminary data and from which the investigators must refine power calculations for the anticipated future trial. Because the investigators hypothesize that an increase in calcium absorption will decrease bone turnover and ultimately increase bone mineral density (BMD), the study will measure biochemical markers of bone turnover in this pilot. Secondary outcomes will be gastrointestinal tolerability and acceptability. On an exploratory basis, the study will determine effects of the prebiotic on the gut microbiome. This pilot will yield critical experience about feasibility of recruitment and adherence to the intervention and measurements.

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.
20

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.
  • Phase 2

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

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Postmenopausal women (no menses for ≥4 yrs)
  2. ≤ 75 yrs old,
  3. Underwent Roux-en-Y gastric bypass surgery for weight loss 2-6 years prior

Exclusion Criteria:

  1. Serum 25(OH)vitamin D level <30 ng/mL (to remove the effect of vitamin D insufficiency/deficiency)*
  2. History of >1 bariatric surgical procedure
  3. Antibiotic therapy in the last 3 months
  4. Regular pre- or probiotic use in the last 3 months
  5. Regain of >50% of weight loss post-bypass
  6. Calculated creatinine clearance <30 mL/min
  7. Serum calcium >10.2 mg/dL
  8. Use of hormone therapy, osteoporosis pharmacotherapy, glucocorticoids, or other medications impacting calcium metabolism
  9. Thyroid stimulating hormone (TSH) <0.01 milli-international units per liter (mIU/L)

A potential participant may be excluded if she has a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.

*Women excluded due to 25(OH)D level will be offered re-screening after vitamin D supplementation.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • 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: Prebiotic: soluble corn fiber
SCF (PromotorTM Soluble Corn Fiber 85, provided by manufacturer Tate & Lyle) will be dispensed to participants as a dry powder in sachets of 12 g SCF85 product (which is approximately 10 g fiber). Participants will mix the powder into 250 mL water and consume two such beverages daily, ≥1 hour apart. (For the first week, all participants will consume one beverage daily, and subsequently increase to one beverage twice daily.) Participants will be asked to substitute these for 500 mL of their usual daily water intake but to make no other dietary changes.
Dietary supplement: Prebiotic: soluble corn fiber
prebiotic
Other Names:
  • PROMOTOR 85
Placebo Comparator: Placebo
The placebo control will be maltodextrin powder in identical sachets. Participants will mix the powder into 250 mL water and consume two such beverages daily, ≥1 hour apart. (For the first week, all participants will consume one beverage daily, and subsequently increase to one beverage twice daily.) Participants will be requested to substitute these for 500 mL of their usual daily water intake but to make no other dietary changes.
Dietary supplement: Placebo: maltodextrin
placebo

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
Change in fractional intestinal calcium absorption
Time Frame: 2 months
Fractional calcium absorption to be determined using dual stable isotopic tracers
2 months

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
Change in bone turnover markers
Time Frame: 2 months
Serum biochemical markers of bone turnover C-telopeptide (CTX) and procollagen type 1 N-terminal propeptide (P1NP)
2 months
Gastrointestinal tolerability
Time Frame: 2 months
Self-reported flatulence, bloating, abdominal pain, stomach noises
2 months
Acceptability
Time Frame: 2 months
Self-reported satisfaction, likelihood that one would be willing to consume the beverage for 12 months
2 months
Change in gut microbiome composition
Time Frame: 2 months
Stool bacterial and fungal composition to be analyzed, including alpha diversity and beta diversity metrics as well as taxon relative abundance, with subsequent in silico metagenomic predictions of enrichment of bacterial functional gene pathways
2 months

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.
San Francisco Veterans Affairs Medical Center

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.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, San Francisco

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: Anne Schafer, MD, UCSF & SFVAMC

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.
November 21, 2017

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.
January 31, 2020

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.
January 31, 2020

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).
August 25, 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.
September 1, 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.
September 5, 2017

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.
October 22, 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.
October 20, 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.
October 1, 2020

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.
  • 17-22618
  • R21DK112126 (U.S. NIH Grant/Contract)

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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