All > Osteopenia > Microbiome

Time restricted eating and calorie restriction for Weight Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Weight Loss+2 MoreCalorie Restriction - Behavioral
Eligibility
50 - 79
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Weight Loss
  • Osteoporosis
  • Time-Restricted Feeding

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

3 Primary · 16 Secondary · Reporting Duration: change from baseline to an average 6 months

Month 6
25-hydroxyvitamin D (25OHD)
6 minute walk test
Bone structure of radius
BMD (lumbar spine, femoral neck, radius, total body)
Blood pressure
Blood pressure (systolic and diastolic)
Bone mineral density (BMD - hip)
Circumferences
Cognitive function
Cortical and total (vBMD)
Mineral oil
Cortical bone (volumetric mineral density, thickness, and porosity)
Diet quality score
Eating self-efficacy
Collagen
Osteocalcin
Fasting procollagen type 1 N-terminal propeptide (PINP)
Fat mass
Glucose
Glucose
Hand Grip
Insulin
Insulin - response to oral glucose tolerance test
Lean body mass
Microbiota
Quality of sleep
Short physical performance battery (SPPB)
Soft tissue (lean and fat mass)
Timed up and go
Trabecular bone (volumetric mineral density, bone volume / total volume, and separation)
Cancellous Bone
Trabecular separation
Mineral oil
Waist Circumference
Weight loss
cortisol
estradiol
Melatonin
parathyroid hormone (PTH)

Trial Safety

Safety Progress

1 of 3

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1
Lifestyle Intervention
3
Drospirenone
3
LF111 (drospirenone)

Trial Design

2 Treatment Groups

Calorie restriction alone
1 of 2
Time restricted eating and calorie restriction
1 of 2

Active Control

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Time restricted eating and calorie restriction · No Placebo Group · N/A

Time restricted eating and calorie restrictionExperimental Group · 2 Interventions: Calorie Restriction, Time Restricted Eating (TRE) · Intervention Types: Behavioral, Behavioral
Calorie restriction alone
Behavioral
ActiveComparator Group · 1 Intervention: Calorie Restriction · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calorie Restriction
2015
N/A
~480

Trial Logistics

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to an average 6 months

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
374 Previous Clinical Trials
58,498 Total Patients Enrolled
2 Trials studying Weight Loss
35 Patients Enrolled for Weight Loss

Eligibility Criteria

Age 50 - 79 · Female Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are postmenopausal.\n
You have a body mass index (BMI) of 25-39 kg/m2.
You consume food for at least 14 hours/day.

Who else is applying?

What state do they live in?
New York28.6%
Oregon14.3%
Minnesota14.3%
Other42.9%
How old are they?
18 - 65100.0%
What site did they apply to?
Sue A Shapses25.0%
Rutgers University - NJ Inst Food Nutrition & Health75.0%
What portion of applicants met pre-screening criteria?
Met criteria57.1%
Did not meet criteria42.9%
Why did patients apply to this trial?
  • "The help with weight loss"
  • "I have tried many methods, diets. Nothing works for me. I want to join a trial and see if that helps."
  • "I have been on all types of diets to loss weight to no avail. I am looking for something or hoping I can help find something for myself and others to lose weight."
What questions have other patients asked about this trial?
  • "How long does the study take? Is it dangerous? Does it require medication? How much does the study pay?"
How many prior treatments have patients received?
0100.0%
References

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