PRebiotic to IMprovE Calcium Absorption
Completed · Phase 2 · Has a placebo group
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT03272542
- Run by
- San Francisco Veterans Affairs Medical Center
- People needed
- 20
- Starts
- 2017-11-21
- Expected to finish
- 2020-01-31
- Last updated by the study team
- 2020-10-22
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- UCSF — San Francisco, California, United States
Full record on ClinicalTrials.gov
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