TRE: Microbiome, Metabolic Health and Bone

Weight Loss Clinical Trial

— TREMBO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548517
• Other study ID #: Pro2021002434
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Prinicipal Investigator
• Phone: 848-932-9403
• Email: shapses[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss
• Time Restricted Feeding
• Weight Loss

Intervention

Behavioral:
• Time Restricted Eating (TRE)
9-hour eating window
• Calorie Restriction
daily calorie restriction

Locations

Country	Name	City	State
United States	Rutgers University - NJ Inst Food Nutrition & Health	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	25-hydroxyvitamin D (25OHD)	serum	change from baseline to an average 6 months
Other	estradiol	serum	change from baseline to an average 6 months
Other	parathyroid hormone (PTH)	serum	change from baseline to an average 6 months
Other	Fasting osteocalcin	serum bone formation and energy marker	change from baseline to an average 6 months
Other	Fasting procollagen type 1 N-terminal propeptide (PINP)	serum bone formation marker	change from baseline to an average 6 months
Other	Fasting C-telopeptide of type I collagen (CTX)	serum bone resorption marker	change from baseline to an average 6 months
Other	Cognitive function	Cambridge Neuropsychological Test Automated Battery	change from baseline to an average 6 months
Other	melatonin	serum	change from baseline to an average 6 months
Other	cortisol	serum	change from baseline to an average 6 months
Other	Quality of sleep	Pittsburgh sleep quality index (0-21; higher score is worse)	change from baseline to an average 6 months
Other	Diet quality score	nutrient analysis software (Healthy Eating Index 0-100; higher score is better)	change from baseline to an average 6 months
Other	Eating self-efficacy	Weight lifestyle efficacy questionnaire short-form (0-80; higher score is better)	change from baseline to an average 6 months
Other	Circumferences	tape measure (waist, hip and thigh)	change from baseline to an average 6 months
Other	Short physical performance battery (SPPB)	Total score of SPPB (0-12; higher score is better)	change from baseline to an average 6 months
Other	6 minute walk test	total distance	change from baseline to an average 6 months
Other	Timed up and go	total time	change from baseline to an average 6 months
Other	Hand Grip	dynanometer (isometric grip force)	change from baseline to an average 6 months
Primary	Weight loss	Body weight in kg	change from baseline to an average 6 months
Primary	Bone mineral density (BMD - hip)	dual energy x-ray absorptiometry	change from baseline to an average 6 months
Primary	Microbiota	stool	change from baseline to an average 6 months
Secondary	Soft tissue (lean and fat mass)	dual energy x-ray absorptiometry	change from baseline to an average 6 months
Secondary	Areal BMD (lumbar spine, femoral neck, radius, total body)	dual energy x-ray absorptiometry	change from baseline to an average 6 months
Secondary	Trabecular bone (volumetric BMD, bone volume / total volume, and separation)	peripheral quantitative computed tomography	change from baseline to an average 6 months
Secondary	Cortical bone (volumetric BMD, thickness, and porosity) and total BMD	peripheral quantitative computed tomography	change from baseline to an average 6 months
Secondary	Blood pressure (systolic and diastolic)	sphygmomanometer	change from baseline to an average 6 months
Secondary	Glucose - response to oral glucose tolerance test	fasting and response to glucose solution	change from baseline to an average 6 months
Secondary	Insulin - response to oral glucose tolerance test	fasting and response to glucose solution	change from baseline to an average 6 months