TREMBO: TRE: Microbiome, Metabolic Health and Bone

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05548517

Collaborator

(none)

Enrollment

Arms

32.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss Time Restricted Feeding Bone Loss	Behavioral: Time Restricted Eating (TRE) Behavioral: Calorie Restriction	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled TrialRandomized Controlled Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Time Restricted Eating on the Microbiome Affecting Metabolic Health and Bone in Older Women

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Time restricted eating and calorie restriction Subjects will be asked to adhere to a calorie-restricted diet and will be counseled by a dietitian for diet and lifestyle behavior education. In addition, they will be asked to only consume calories during a 9-hour window (15:9).	Behavioral: Time Restricted Eating (TRE) 9-hour eating window Behavioral: Calorie Restriction daily calorie restriction
Active Comparator: Calorie restriction alone Subjects will be asked to adhere to a calorie-restricted diet and will be counseled by a dietitian for diet and lifestyle behavior education. They will be advised to continue to consume foods throughout the day and into the evening.	Behavioral: Calorie Restriction daily calorie restriction

Arm

Intervention/Treatment

Experimental: Time restricted eating and calorie restriction

Subjects will be asked to adhere to a calorie-restricted diet and will be counseled by a dietitian for diet and lifestyle behavior education. In addition, they will be asked to only consume calories during a 9-hour window (15:9).

Behavioral: Time Restricted Eating (TRE)

9-hour eating window

Behavioral: Calorie Restriction

daily calorie restriction

Active Comparator: Calorie restriction alone

Subjects will be asked to adhere to a calorie-restricted diet and will be counseled by a dietitian for diet and lifestyle behavior education. They will be advised to continue to consume foods throughout the day and into the evening.

Behavioral: Calorie Restriction

daily calorie restriction

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Soft tissue (lean and fat mass) [change from baseline to an average 6 months]
dual energy x-ray absorptiometry
BMD (lumbar spine, femoral neck, radius, total body) [change from baseline to an average 6 months]
dual energy x-ray absorptiometry
Trabecular bone (volumetric mineral density, bone volume / total volume, and separation) [change from baseline to an average 6 months]
peripheral quantitative computed tomography
Cortical bone (volumetric mineral density, thickness, and porosity) [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
Glucose - response to oral glucose tolerance test [change from baseline to an average 6 months]
fasting and response to glucose solution
Insulin - response to oral glucose tolerance test [change from baseline to an average 6 months]
fasting and response to glucose solution

Other Outcome Measures

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
Cortical and total volumetric bone mineral density [change from baseline to an average 6 months]
peripheral quantitative computed tomography
Cognitive function [change from baseline to an average 6 months]
Cambridge Neuropsychological Test Automated Battery
melatonin [change from baseline to an average 6 months]
serum
cortisol [change from baseline to an average 6 months]
serum
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)
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)
Short physical performance battery (SPPB) [change from baseline to an average 6 months]
Total score of SPPB (0-12; higher score is better)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 79 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Postmenopausal women (>2 years since last menses)
Body mass index (25-39 kg/m2)
Habitual consumption of food for at least 14 hours/day

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 6 months
Current diagnosis or history of cancer
History of surgical procedure for weight loss
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.