PRebiotic to IMprovE Calcium Absorption

NCT03272542 | Completed Phase 2

• 2 other identifiers: 17-22618R21DK112126
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

gastric bypass; calcium absorption; postmenopausal women

Outcome Measures

Primary Outcomes (1)

• Change in fractional intestinal calcium absorption

  Fractional calcium absorption to be determined using dual stable isotopic tracers

  2 months

Secondary Outcomes (4)

• Change in bone turnover markers

  2 months

• Gastrointestinal tolerability

  2 months

• Acceptability

  2 months

• Change in gut microbiome composition

  2 months

Study Arms (2)

Prebiotic: soluble corn fiber

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Prebiotic: soluble corn fiber DIETARY_SUPPLEMENT

prebiotic

Also known as: PROMOTOR 85

Prebiotic: soluble corn fiber

Placebo: maltodextrin DIETARY_SUPPLEMENT

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• San Francisco Veterans Affairs Medical Center: lead
• University of California, San Francisco: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 34888663 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Schafer, MD

  UCSF & SFVAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine and of Epidemiology and Biostatistics; Staff Physician

Model Details: Randomized, placebo-controlled pilot trial with a parallel-arm design

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: September 5, 2017
• Study Start: November 21, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)