Status:
COMPLETED
PRebiotic to IMprovE Calcium Absorption
Lead Sponsor:
San Francisco Veterans Affairs Medical Center
Collaborating Sponsors:
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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 ...
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 t...
Eligibility Criteria
Inclusion
- Postmenopausal women (no menses for ≥4 yrs)
- ≤ 75 yrs old,
- Underwent Roux-en-Y gastric bypass surgery for weight loss 2-6 years prior
Exclusion
- 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.
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03272542
Start Date
November 21 2017
End Date
January 31 2020
Last Update
October 22 2020
Active Locations (1)
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1
UCSF
San Francisco, California, United States, 94143