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New treatment option for Metabolic Syndrome
Official title Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women
ClinicalTrials.gov ID: NCT04893226
What this study is testing
- What it's testing
- This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65, women only. Healthy volunteers may be eligible.
You may be able to join if
- postmenopausal women
- age 45-65 years
- prediabetic or have at least 2 features of metabolic syndrome
You likely can't join if
- on hormone therapy
- diabetes
- heart disease
- alcohol consumption of \>2 drinks per day
- significant circadian disruption
- having care-taking responsibilities that significantly affect sleep
See the full eligibility criteria
- postmenopausal women
- age 45-65 years
- prediabetic or have at least 2 features of metabolic syndrome
- on hormone therapy
- diabetes
- heart disease
- alcohol consumption of \>2 drinks per day
- significant circadian disruption
- having care-taking responsibilities that significantly affect sleep
- shift work or irregular lifestyle
- uncontrolled sleep apnea or other uncontrolled sleep disorder
- extreme early or late chronotypes
- significant psychiatric disorders
- taking ADHD medications
- diagnosed dysregulated eating behaviors
- smoking \>5 cigarettes/day or 30 pack-year history
- participating in formal weight loss program
- not weight stable
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.