DyslipidemiasNCT06188598
Time-restricted Eating in Peri- and Postmenopausal Women
A study testing Time-restricted eating in people with Dyslipidemias and Obesity, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The overall objective of the study is to examine the effect of an 8-hour time-restricted eating intervention on lipid levels and body composition in peri- and recently postmenopausal women with untreated dyslipidemia. Read more about this study
- Who is it for?
- Ages 40 to 58 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Obesity, Menopause
- What is being tested?
- Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2022to 21 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 58 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women aged 40-58 years
- Perimenopausal or recently postmenopausal, >1 year and <5 years
- BMI > 30 kg/m2
- Dyslipidemic, defined as the presence of one or more lipid-based cardiovascular disease risk-enhancing factors per American College of Cardiology/American Heart Association guidelines
- Normal renal and hepatic function
- Perimenopausal women, a negative pregnancy test
Who cannot join
- Dietary factors:
- Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder
- Concurrent dietary intervention or modification unrelated to study procedures
- Psychiatric factors:
- Current major depressive episode
- Suicidal ideation
Show all 37Show fewer
- Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
- Current alcohol/substance use disorder
- Medical factors:
- Use of lipid-lowering or lipid-enhancing medications
- Use of systemic hormonal (estrogens and/or progestin) therapies
- Use of weight loss medications or supplements
- Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months
- Previous weight loss surgery
- Abnormal vital signs at screening visit
- Body weight > 350 pounds, per DXA scan limits
- Malignancy within past 2 years
- Major surgery within past 3 months
- Medical instability considered to interfere with study procedures
- Contraindications to DXA scanning
- Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas)
- Undergoing treatment for cancer
- Use of medications for which time-restricted eating would interfere with recommended timing of medication ingestion with food intake.
- Lifestyle and other factors:
- Irregular sleep/wake schedule
- Shiftwork
- Recent travel across 2 or more time zones
- Recent change in exercise habits
- Work or social schedules that would impede ability to adhere to study protocol
- Adherence factors:
- -Inability to adhere to study procedures completed between screening and randomization visits
- Off-Study Criteria:
- Initiation of new medications for lipid management, weight loss, hormonal medications, or other medications that may cause changes in weight or lipid levels
- Development of any significant medical problem
- Enrollment in another clinical trial involving study procedures or medications that might interfere with study procedures.
- Significant deviation from study protocol or protocol violation
- Inability to adhere to time-restricted eating window
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Leilah K Grant, PhD, 617-525-7118, lgrant@bwh.harvard.edu
About this study
Official title: Time-restricted Eating as a Dietary Intervention for Dyslipidemia in Peri- and Postmenopausal Women
The overall objective of the study is to examine the effect of an 8-hour time-restricted eating intervention on lipid levels and body composition in peri- and recently postmenopausal women with untreated dyslipidemia.
Read the detailed description
This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to ad libitum eating (control) on metabolic health and body composition in recently postmenopausal women with untreated dyslipidemia. Following a 1-week baseline assessment, participants will be randomized to either a TRE or unrestricted control diet schedule (1-to-1 ratio) for 8 weeks. At baseline and weeks 4 and 8 of the intervention, daily eating and sleep patterns will be assessed for one week, followed by collection of fasting lipids and metabolic labs, body weight and vital signs; questionnaires assessing sleep and mood health, actigraphy and body composition via whole-body dual-energy x-ray absorptiometry will be assessed at baseline and week 8.
- Conditions
- Dyslipidemias, Obesity, Menopause
- Being tested
- Time-restricted eating
- Medical subject headings
- Dyslipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
Eating is restricted to an 8-hour window that is the same each day (e.g., 10am - 6pm)
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating (TRE) | Experimental | Participants in the TRE group are instructed to restrict eating to an 8-hr window but were not asked to change the type or amount of food typically consumed. The 8-hour window (e.g., 10am - 6pm) has to be the same each day starting at least 2 hours after wake and ending at least 2 hours before bed. Receives: Behavioral: Time-restricted eating |
| Unrestricted eating | No intervention | Participants are instructed to continue their diet as normal without changing the type, amount or timing of food typically consumed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting triglyceride levels
Pre- to post-intervention change in fasting triglyceride levels (mg/dL)
Measured: Baseline (week 0) and post-intervention (week 8)
Change in visceral adiposity
Pre- to post-intervention change in visceral adiposity (mass) as measured by dual energy x-ray absorptiometry scan
Measured: Baseline (week 0) and post-intervention (week 8)
Secondary outcomes (9)
Change in body weight
Pre- to post-intervention change in body weight (kg)
Measured: Baseline (week 0) and post-intervention (week 8)
Change in high-density lipoprotein cholesterol (HDL-C)
Pre- to post-intervention change in HDL-C (mg/dL)
Measured: Baseline (week 0) and post-intervention (week 8)
Change in low-density lipoprotein cholesterol (LDL-C)
Pre- to post-intervention change in LDL-C (mg/dL)
Measured: Baseline (week 0) and post-intervention (week 8)
Change in systolic blood pressure
Pre- to post-intervention change in systolic blood pressure (mmHg)
Measured: Baseline (week 0) and post-intervention (week 8)
Change in sleep quality
Change in sleep quality as measure by the Pittsburgh Sleep Quality Index (PSQI) global score. PSQI global score range is 0-21 with higher scores indicating more sleep disturbance.
Measured: Baseline (week 0) and post-intervention (week 8)
Change in depressive symptoms
Change in depressive symptoms as measure by the Patient Health Questionnaire-8 (PHQ-8). The PHQ-8 score ranges from 0-24 with higher scores indicating greater depressive symptoms.
Measured: Baseline (week 0) and post-intervention (week 8)
Change in positive and negative affect
Change in positive and negative affect as measure by the Positive and Negative Affect Schedule. The PANAS Positive and Negative scores range from 10-50 with higher scores indicating greater postive and negative affect, respectively.
Measured: Baseline (week 0) and post-intervention (week 8)
Change in sleep duration
Change in sleep duration based on the average of self-reported sleep duration over 1 week
Measured: Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8)
Change in sleep efficiency
Change in sleep efficiency based on the average of self-reported sleep efficiency over 1 week. Sleep efficiency to be calculated as total sleep time/ time in bed.
Measured: Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start21 Dec 2022
- Primary completion21 Dec 2024 (estimated)
- Study completion21 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized on 1:1 bases to time-restricted eating or unrestricted eating
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leilah Kristine Grant, Brigham and Women's Hospital
- Investigators
- Leilah K Grant, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188598
- Sponsor's protocol ID
- 2022P002288
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-restricted Eating as a Dietary Intervention for Dyslipidemia in Peri- and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06188598
- Acronym / sponsor ID
- 2022P002288
- Conditions
- Dyslipidemias, Obesity, Menopause
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 21 Dec 2024 (estimated)
- Study completion
- 21 Dec 2024 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the study is to examine the effect of an 8-hour time-restricted eating intervention on lipid levels and body composition in peri- and recently postmenopausal women with untreated dyslipidemia.
Detailed description
This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to ad libitum eating (control) on metabolic health and body composition in recently postmenopausal women with untreated dyslipidemia. Following a 1-week baseline assessment, participants will be randomized to either a TRE or unrestricted control diet schedule (1-to-1 ratio) for 8 weeks. At baseline and weeks 4 and 8 of the intervention, daily eating and sleep patterns will be assessed for one week, followed by collection of fasting lipids and metabolic labs, body weight and vital signs; questionnaires assessing sleep and mood health, actigraphy and body composition via whole-body dual-energy x-ray absorptiometry will be assessed at baseline and week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized on 1:1 bases to time-restricted eating or unrestricted eating
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating (TRE) | Experimental | Behavioral: Time-restricted eatingParticipants in the TRE group are instructed to restrict eating to an 8-hr window but were not asked to change the type or amount of food typically consumed. The 8-hour window (e.g., 10am - 6pm) has to be the same each day starting at least 2 hours after wake and ending at least 2 hours before bed. |
| Unrestricted eating | No intervention | –Participants are instructed to continue their diet as normal without changing the type, amount or timing of food typically consumed. |
Who may qualify
- Ages
- 40 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy women aged 40-58 years
- Perimenopausal or recently postmenopausal, >1 year and <5 years
- BMI > 30 kg/m2
- Dyslipidemic, defined as the presence of one or more lipid-based cardiovascular disease risk-enhancing factors per American College of Cardiology/American Heart Association guidelines
- Normal renal and hepatic function
Key exclusion criteria (37 listed)
- Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder
- Concurrent dietary intervention or modification unrelated to study procedures
- Current major depressive episode
- Suicidal ideation
- Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted eatingEating is restricted to an 8-hour window that is the same each day (e.g., 10am - 6pm) | Behavioural | Time-restricted eating (TRE) |
Primary outcome
Change in fasting triglyceride levels
Time frame: Baseline (week 0) and post-intervention (week 8)
Pre- to post-intervention change in fasting triglyceride levels (mg/dL)
Change in visceral adiposity
Time frame: Baseline (week 0) and post-intervention (week 8)
Pre- to post-intervention change in visceral adiposity (mass) as measured by dual energy x-ray absorptiometry scan
9 secondary outcomes
Change in body weight
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in high-density lipoprotein cholesterol (HDL-C)
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in systolic blood pressure
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in sleep quality
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in depressive symptoms
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in positive and negative affect
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in sleep duration
Time frame: Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8)
Change in sleep efficiency
Time frame: Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leilah K Grant, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating in people with Dyslipidemias and Obesity, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leilah K Grant, PhD (6175257118, lgrant@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting triglyceride levels (time frame: Baseline (week 0) and post-intervention (week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.