Weight Loss, Time Restricted Feeding, Bone Loss
Conditions
Keywords
bone mineral density, Microbiome, obesity and overweight, metabolic health, time restricted feeding, energy restriction
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.
Interventions
BEHAVIORALTime Restricted Eating (TRE)
9-hour eating window
BEHAVIORALCalorie Restriction
daily calorie restriction
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Trial Enroll 48 to achieve sample size of 40 (20/group)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | change from baseline to an average 6 months | Body weight in kg |
| Bone mineral density (BMD - hip) | change from baseline to an average 6 months | dual energy x-ray absorptiometry |
| Microbiota | change from baseline to an average 6 months | stool |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cortical bone (volumetric BMD, thickness, and porosity) and total BMD | change from baseline to an average 6 months | peripheral quantitative computed tomography |
| Blood pressure (systolic and diastolic) | change from baseline to an average 6 months | sphygmomanometer |
| Soft tissue (lean and fat mass) | change from baseline to an average 6 months | dual energy x-ray absorptiometry |
| Insulin - response to oral glucose tolerance test | change from baseline to an average 6 months | fasting and response to glucose solution |
| Glucose - response to oral glucose tolerance test | change from baseline to an average 6 months | fasting and response to glucose solution |
| Areal BMD (lumbar spine, femoral neck, radius, total body) | change from baseline to an average 6 months | dual energy x-ray absorptiometry |
| Trabecular bone (volumetric BMD, bone volume / total volume, and separation) | change from baseline to an average 6 months | peripheral quantitative computed tomography |
Other
| Measure | Time frame | Description |
|---|---|---|
| melatonin | change from baseline to an average 6 months | serum |
| Eating self-efficacy | change from baseline to an average 6 months | Weight lifestyle efficacy questionnaire short-form (0-80; higher score is better) |
| Circumferences | change from baseline to an average 6 months | tape measure (waist, hip and thigh) |
| cortisol | change from baseline to an average 6 months | serum |
| 6 minute walk test | change from baseline to an average 6 months | total distance |
| Timed up and go | change from baseline to an average 6 months | total time |
| Hand Grip | change from baseline to an average 6 months | dynanometer (isometric grip force) |
| Short physical performance battery (SPPB) | change from baseline to an average 6 months | Total score of SPPB (0-12; higher score is better) |
| Quality of sleep | change from baseline to an average 6 months | Pittsburgh sleep quality index (0-21; higher score is worse) |
| Diet quality score | change from baseline to an average 6 months | nutrient analysis software (Healthy Eating Index 0-100; higher score is better) |
| 25-hydroxyvitamin D (25OHD) | change from baseline to an average 6 months | serum |
| estradiol | change from baseline to an average 6 months | serum |
| parathyroid hormone (PTH) | change from baseline to an average 6 months | serum |
| Fasting osteocalcin | change from baseline to an average 6 months | serum bone formation and energy marker |
| Fasting procollagen type 1 N-terminal propeptide (PINP) | change from baseline to an average 6 months | serum bone formation marker |
| Fasting C-telopeptide of type I collagen (CTX) | change from baseline to an average 6 months | serum bone resorption marker |
| Cognitive function | change from baseline to an average 6 months | Cambridge Neuropsychological Test Automated Battery |
Countries
United States
Outcome results
None listed