Prebiotics in Women's Health and Aging: The Gut-Bone Connection
Indiana University
Summary
Prior studies have shown that dietary supplementation with dried plums (also known as prunes) reduces bone loss in postmenopausal women. The purpose of this clinical trial is to understand how dried plums mediate their effects on bone. The main questions the study will answer are: 1. Does adding dried plums to the diet alter immune cell function? 2. Does dried plum alter gut microbes? 3. Does a person's vitamin D status influence this response? Researcher will compare the response following consumption of the normal diet to supplementing the diet with dried plums. Participant will: 1. Consume their normal diet or supplement their normal diet dried plums for four week periods over the course of 3-4 months. 2. Complete 5 study visits scheduled. 3. Perform some physical function tests and have a bone density scan at the beginning of the study. 4. Complete questionnaires, a 3-day food record, and provide stool and blood samples at 4 different timepoints during the study. 5. Record information about their bowel habits
Description
Each year in the U.S., an estimated 2 million women (\~6,000 women each day) reach the critical stage of female reproductive aging known as menopause. Menopause is characterized by the permanent cessation of menses and the loss of ovarian follicular activity brought about by the decline in 17β-estradiol (i.e., estrogen deficiency). Among American women, the median age of menopause is 51 y \[1\]. Based on a current life expectancy of 80.5 yrs, women in this country can expect to spend up to one-third of their lifetime in this postmenopausal stage. The impact of decreasing 17β-estradiol on immu…
Eligibility
- Age range
- 60–75 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * women 60-75 years of age at the start of the study; * 12 or more consecutive months without a menstrual period; * willing to include dried plums in their daily diet and collect fecal samples at four time points; * ambulatory without assistance; * capacity to give informed consent. Exclusion Criteria: * women who have been on medications known to alter bone or calcium metabolism (e.g., oral bisphosphonates, raloxifene, denosumab, intermittent parathyroid hormone, growth hormone) within 12 months of starting the study. Prior use of intravenous bisphosphonates at any time…
Interventions
- Dietary SupplementDried plums
Participants will supplement their regular diet with 50 g of dried plum (5-6 dried plums) per day.
Location
- IU Health University Hospital Clinical Research CenterIndianapolis, Indiana