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ObesityPhase 2PRIMENCT03272542

PRebiotic to IMprovE Calcium Absorption

A Phase 2 study testing Prebiotic: soluble corn fiber in people with Obesity, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Obesity
What is being tested?
Prebiotic: soluble corn fiber
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
21 Nov 2017to 31 Jan 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Serum 25(OH)vitamin D level <30 ng/mL (to remove the effect of vitamin D insufficiency/deficiency)*
  • History of >1 bariatric surgical procedure
  • Antibiotic therapy in the last 3 months
  • Regular pre- or probiotic use in the last 3 months
  • Regain of >50% of weight loss post-bypass
  • Calculated creatinine clearance <30 mL/min
Show all 11Show fewer
  • Serum calcium >10.2 mg/dL
  • Use of hormone therapy, osteoporosis pharmacotherapy, glucocorticoids, or other medications impacting calcium metabolism
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Obesity
Being tested
Prebiotic: soluble corn fiber, Placebo: maltodextrin
Keywords
gastric bypass, calcium absorption, postmenopausal women
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prebiotic: soluble corn fiberDietary supplement

    Also called PROMOTOR 85

    prebiotic

  • Placebo: maltodextrinDietary supplement

    placebo

Study groups in NCT03272542
Study groupRoleWhat they receive
Prebiotic: soluble corn fiberExperimentalSCF (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.
Receives: Dietary Supplement: Prebiotic: soluble corn fiber
PlaceboPlacebo comparatorThe 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.
Receives: Dietary Supplement: Placebo: maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in fractional intestinal calcium absorption

    Fractional calcium absorption to be determined using dual stable isotopic tracers

    Measured: 2 months

Secondary outcomes (4)

  1. Change in bone turnover markers

    Serum biochemical markers of bone turnover C-telopeptide (CTX) and procollagen type 1 N-terminal propeptide (P1NP)

    Measured: 2 months

  2. Gastrointestinal tolerability

    Self-reported flatulence, bloating, abdominal pain, stomach noises

    Measured: 2 months

  3. Acceptability

    Self-reported satisfaction, likelihood that one would be willing to consume the beverage for 12 months

    Measured: 2 months

  4. Change in gut microbiome composition

    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

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2017
  2. Study start21 Nov 2017
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, placebo-controlled pilot trial with a parallel-arm design
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03272542
Sponsor's protocol ID
17-22618
Other IDs
R21DK112126
Acronym
PRIME
Status last verified
Oct 2020
First submitted
25 Aug 2017
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wu KC, Cao S, Weaver CM, King NJ, Patel S, Kingman H, Sellmeyer DE, McCauley K, Li D, Lynch SV, Kim TY, Black DM, Shafer MM, Ozcam M, Lin DL, Rogers SJ, Stewart L, Carter JT, Posselt AM, Schafer AL. Prebiotic to Improve Calcium Absorption in Postmenopausal Women After Gastric Bypass: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2022 Mar 24;107(4):1053-1064. doi: 10.1210/clinem/dgab883.

    PubMed 34888663

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prebiotic: soluble corn fiber in people with Obesity, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fractional intestinal calcium absorption (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03272542, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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