Clinical trial NCT05548517: TRE: Microbiome, Metabolic Health and Bone
Official title: Time Restricted Eating on the Microbiome Affecting Metabolic Health and Bone in Older Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Weight Loss
Time Restricted Feeding
Bone Loss
Keywords: bone mineral density
Microbiome
obesity and overweight
metabolic health
time restricted feeding
energy restriction
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 48
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial

Enroll 48 to achieve sample size of 40 (20/group)
Primary purpose: TREATMENT

Brief summary: In the Time-Restricted Eating: Microbiome and Bone (TREMBO) study, the primary goal is to determine the effect of time-restricted eating with caloric restriction compared to caloric restriction alone on body weight, the gut microbiota, and bone health in older women who are overweight or obese.

Detailed description: Time-restricted eating (TRE) has gained increased attention due to the possibility to induce weight loss and improve cardiometabolic health as a result of the purported alignment of circadian rhythm. However, since TRE is often reported to cause a spontaneous reduction of calories, it is not well understood if these health benefits are due to weight loss, circadian rhythm alignment, or a combination of the two. Furthermore, while weight loss can improve cardiometabolic health, it can also induce bone loss, which is problematic in older women who are at a higher risk of fracture. Interestingly, both bone turnover and the gut microbiota are responsive to diurnal variations, such as meal timing, and alterations in the gut microbiota have been associated with differences in bone health. In rodent models, caloric restriction can alter the gut microbiota composition with further alterations shown due to time-restricted eating. This suggests that time-restricted eating could affect bone health, which may be partially mediated by changes in the gut microbiota. Also, lifestyle patterns affects both the microbiota and bone. This randomized controlled trial will use behavior modification to examine TRE plus caloric restriction (CR) to achieve an evening energy deficit compared to CR alone on body weight, the gut microbiota, and bone health in older women who are overweight or obese.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women (\>2 years since last menses)
* Body mass index (25-45 kg/m2)
* Agree to be randomly assigned to consume food for ≤ 9 hours/day or ≥12 hours/day
* Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)

Exclusion Criteria:

* Participants with \>5% weight loss in the past 6 months or extreme dietary/physical activity habits
* An inability to follow the experimental intervention or to perform the required specimen collections
* Antibiotic use in the past 2 months
* Current diagnosis, or history of cancer in past 3 years
* History of surgical procedure for weight loss in the past 3 years
* Current diagnosis or history of bone diseases, type I or II diabetes, gastrointestinal disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, cardiac, or renal disease
* Uncontrolled hypertension or hyperlipidemia in abnormal ranges
* Regular use of medications that affect bone metabolism, including bisphosphonates or hormone replacement.
* A colonoscopy within the past 2 months
* Alcohol or illicit drug abuse
* Current smoker or having quit smoking in the past 3 months
* Shift work
* Participation in another clinical research trial which may interfere with the results of this study.

Primary outcomes:
measure: Weight loss
timeFrame: change from baseline to an average 6 months
measure: Bone mineral density (BMD - hip)
timeFrame: change from baseline to an average 6 months
measure: Microbiota
timeFrame: change from baseline to an average 6 months
Secondary outcomes:
measure: Soft tissue (lean and fat mass)
timeFrame: change from baseline to an average 6 months
measure: Areal BMD (lumbar spine, femoral neck, radius, total body)
timeFrame: change from baseline to an average 6 months
measure: Trabecular bone (volumetric BMD, bone volume / total volume, and separation)
timeFrame: change from baseline to an average 6 months
measure: Cortical bone (volumetric BMD, thickness, and porosity) and total BMD
timeFrame: change from baseline to an average 6 months
measure: Blood pressure (systolic and diastolic)
timeFrame: change from baseline to an average 6 months
measure: Glucose - response to oral glucose tolerance test
timeFrame: change from baseline to an average 6 months
measure: Insulin - response to oral glucose tolerance test
timeFrame: change from baseline to an average 6 months
Other outcomes:
measure: 25-hydroxyvitamin D (25OHD)
timeFrame: change from baseline to an average 6 months
measure: estradiol
timeFrame: change from baseline to an average 6 months
measure: parathyroid hormone (PTH)
timeFrame: change from baseline to an average 6 months
measure: Fasting osteocalcin
timeFrame: change from baseline to an average 6 months
measure: Fasting procollagen type 1 N-terminal propeptide (PINP)
timeFrame: change from baseline to an average 6 months
measure: Fasting C-telopeptide of type I collagen (CTX)
timeFrame: change from baseline to an average 6 months
measure: Cognitive function
timeFrame: change from baseline to an average 6 months
measure: melatonin
timeFrame: change from baseline to an average 6 months
measure: cortisol
timeFrame: change from baseline to an average 6 months
measure: Quality of sleep
timeFrame: change from baseline to an average 6 months
measure: Diet quality score
timeFrame: change from baseline to an average 6 months
measure: Eating self-efficacy
timeFrame: change from baseline to an average 6 months
measure: Circumferences
timeFrame: change from baseline to an average 6 months
measure: Short physical performance battery (SPPB)
timeFrame: change from baseline to an average 6 months
measure: 6 minute walk test
timeFrame: change from baseline to an average 6 months
measure: Timed up and go
timeFrame: change from baseline to an average 6 months
measure: Hand Grip
timeFrame: change from baseline to an average 6 months
Locations:
city: New Brunswick
country: United States
facility: Rutgers University - NJ Inst Food Nutrition & Health
state: New Jersey
Study officials:
References: