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PRebiotic to IMprovE Calcium Absorption (PRIME)

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ClinicalTrials.gov Identifier: NCT03272542
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : February 14, 2018
Sponsor:
Collaborators:
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Anne Schafer, San Francisco Veterans Affairs Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Prebiotic: soluble corn fiber Dietary Supplement: Placebo: maltodextrin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo-controlled pilot trial with a parallel-arm design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Prebiotic Intervention to Improve Calcium Absorption After Gastric Bypass Surgery
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
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 Name: 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




Primary Outcome Measures :
  1. Change in fractional intestinal calcium absorption [ Time Frame: 2 months ]
    Fractional calcium absorption to be determined using dual stable isotopic tracers


Secondary Outcome Measures :
  1. 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. Gastrointestinal tolerability [ Time Frame: 2 months ]
    Self-reported flatulence, bloating, abdominal pain, stomach noises

  3. Acceptability [ Time Frame: 2 months ]
    Self-reported satisfaction, likelihood that one would be willing to consume the beverage for 12 months

  4. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272542


Contacts
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Contact: Anne Schafer, MD 415-221-4810 ext 24895 anne.schafer@ucsf.edu
Contact: Heather Freasier, MS, RD 415-379-5518 heather.freasier@ucsf.edu

Locations
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United States, California
UCSF Recruiting
San Francisco, California, United States, 94143
Contact: Nicole King    415-221-4810 ext 10580    nicole.king@ucsf.edu   
Contact: Anne Schafer, MD    415-221-4810 ext 24895    anne.schafer@ucsf.edu   
Sponsors and Collaborators
San Francisco Veterans Affairs Medical Center
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Anne Schafer, MD UCSF & SFVAMC

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Responsible Party: Anne Schafer, Assistant Professor of Medicine and of Epidemiology and Biostatistics; Staff Physician, San Francisco Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03272542     History of Changes
Other Study ID Numbers: 17-22618
R21DK112126 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne Schafer, San Francisco Veterans Affairs Medical Center:
gastric bypass
calcium absorption
postmenopausal women
Additional relevant MeSH terms:
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Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents