Healthy, no Evidence of DiseaseNCT02154984
Time Restricted Diet in Obese or Overweight Pre or Postmenopausal Participants
A study testing behavioral dietary intervention, telephone-based intervention and laboratory biomarker analysis in people with Healthy, no Evidence of Disease and Obesity, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to study the relationships between obesity, hormones and menopausal status, and breast cancer. The researchers would like to study whether a type of nutritional intervention, called a time-restricted diet or tRD, is easy to maintain using a smartphone application; the researchers also want… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease, Obesity
- What is being tested?
- behavioral dietary intervention, telephone-based intervention and laboratory biomarker analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 23 Feb 2017
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must have a stable weight (have not gained or lost 25 pounds in the last 6 months)
- Subjects must have had a normal mammogram within 9 months prior to registration; NOTE: subjects must also have a normal breast exam on the day of the pre-intervention random fine needle aspiration (rFNA)
- Subjects must have a body mass index (BMI) of 25-40
- Subjects must fit into ONE of the following menopausal categories:
- Premenopausal (n = 40) - defined as meeting all the following criteria:
- Have had at least 8 menstrual cycles in the past 12 months
Show all 20Show fewer
- Have had no hormonal contraception in the past 3 months prior to registration
- Have serum hormone parameters (estradiol [E2], progesterone, follicle stimulating hormone [FSH]) in premenopausal range on the day of rFNA; NOTE: subjects will self-report menopausal status at registration, and confirmation of hormonal parameters will occur after registration as part of pre-intervention procedures; if there is mis-assignment of status, the recruitment of future subjects will be adjusted accordingly
- Postmenopausal (n = 40) - defined as meeting all of the following criteria:
- Last menstrual period (LMP) > 1 year previously
- Have had no hormone use in the past 3 months prior to registration
- Serum E2, progesterone, FSH in postmenopausal range on the day of rFNA; NOTE: subjects will self-report menopausal status at registration, and confirmation of hormonal parameters will occur after registration as part of pre-intervention procedures; if there is mis-assignment of status, the recruitment of future subjects will be adjusted accordingly
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Subjects who have been diagnosed with a prior cancer at any site (other than breast cancer) may participate as long as they have been off medical therapy for at least 12 months prior to registration
- Subjects with prior breast cancer must be off all systemic therapy (including endocrine agents) for at least 2 years prior to registration
- Subjects must be willing to undergo a random fine needle aspiration (rFNA) at the beginning and end of the intervention period
- Subjects must be willing and able to abstain from the use of aspirin for at least 2 weeks prior to undergoing each rFNA procedure (pre- and post-intervention)
- Subjects must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
- Subjects must have a smart phone (newer generation Android or any Iphone) to be able to track their food intake times
- Subjects must be willing to restrict food intake to an 8 hour period every day (12 pm to 8 pm)
Who cannot join
- Subjects who have received hormonal contraception and/or hormone therapy in the past 3 months are not eligible
- Subjects who are pregnant and/or lactating are not eligible
- Subjects who are noted (upon initial online screening) to do 150 minutes or more of moderate level physical activity each week, get less than 8% of their calories from saturated fat, and eat more than 5 fruit and vegetable servings per day will not be eligible
- Subjects who are part of any structured weight loss programs (e.g. Weight Watchers, etc.) are not eligible
- Subjects who have undergone bariatric surgery are not eligible
- Subjects who work night shifts are not eligible
- Subjects who have diabetes or uncontrolled hypertension are not eligible; NOTE: for the purposes of this study, uncontrolled will be defined as diastolic pressure over 100 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Time Restricted Diet in Obese/Overweight Pre &Amp; Postmenopausal Women
The purpose of this study is to study the relationships between obesity, hormones and menopausal status, and breast cancer. The researchers would like to study whether a type of nutritional intervention, called a time-restricted diet or tRD, is easy to maintain using a smartphone application; the researchers also want to study the effect that a tRD has on weight control, hormones, and breast tissue. A tRD is a type of diet that requires people to restrict their daily eating to a specific time frame each day. The researchers think that this might be an effective and manageable way to control weight.
Read the detailed description
PRIMARY OBJECTIVES:
- Feasibility of fostering adherence to self-monitoring of dietary intake using a smartphone application (app).
II. Feasibility of the goal of following a time-restricted diet.
SECONDARY OBJECTIVES:
- Identify potential molecular biomarkers and/or signatures to explore its efficacy for the normalization of metabolism.
II. Assess the systemic endocrine effects of a time restricted diet (tRD) intervention in overweight and obese pre and postmenopausal women.
III. Assess weight change following a tRD intervention. IV. Evaluate the effects of a tRD intervention, and identify a specific and reproducible genomic signature, in breast samples obtained by random fine needle aspiration in the tRD study population.
- Assess the volume of parenchymal enhancement on magnetic resonance imaging (MRI).
OUTLINE:
Participants follow a time restricted diet, which restricts daily eating to an 8 hour time window between 12:00-8:00 pm. Participants are allowed to consume non-caloric beverages (water, black tea, black coffee, diet soda, etc.) during the fasting hours and required to record daily food consumption in the smartphone app for 6 months. Participants are also coached by telephone over approximately 10-15 minutes weekly for 1 month and then biweekly for 5 months.
After completion, participants are followed up for 3 months.
- Conditions
- Healthy, no Evidence of Disease, Obesity
- Being tested
- behavioral dietary intervention, telephone-based intervention, laboratory biomarker analysis
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral dietary interventionBehavioural
Follow tRD
telephone-based interventionBehavioural
Receive coaching calls
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Behavioral (time restricted diet) | Experimental | Participants follow a time restricted diet, which restricts daily eating to an 8 hour time window between 12:00-8:00 pm. Participants are allowed to consume non-caloric beverages (water, black tea, black coffee, diet soda, etc.) during the fasting hours and required to record daily food consumption in the smartphone app for 6 months. Participants are also coached by telephone over approximately 10-15 minutes weekly for 1 month and then biweekly for 5 months. Receives: Behavioral: behavioral dietary intervention; Behavioral: telephone-based intervention; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to self-monitoring
Assessed by demonstrating that at least 65% of participants record dietary intake on at least 80% of study intervention days. Adherence will be assessed via a one-sample chi-squared test for proportions.
Measured: Up to 3 months after completion of study
Attaining the goal of dietary time restriction
Assessed by demonstrating that at least 65% of participants recorded appropriate time restriction on at least 80% of study days.
Measured: Up to 3 months after completion of study
Secondary outcomes (9)
Changes in steroid hormones (estradiol, progesterone, testosterone) levels
Blood samples will be taken and representative values (mean, standard deviation, median, and range) of hormones and adipokine measurements will be used to calculate changes following intervention, which will then be used for univariate analysis using menopausal status and change in BMI as the main predictors of interest. These analyses are exploratory and descriptive of the systemic endocrine/adipokine environment; they will be related to gene expression changes. Correlations between changes in BMI and changes in biomarker levels will be assessed via the Spearman correlation.
Measured: Baseline to up to 3 months after completion of study
Changes in gonadotropins (FSH) levels
Blood samples will be taken and representative values (mean, standard deviation, median, and range) of hormones and adipokine measurements will be used to calculate changes following intervention, which will then be used for univariate analysis using menopausal status and change in BMI as the main predictors of interest. These analyses are exploratory and descriptive of the systemic endocrine/adipokine environment; they will be related to gene expression changes. Correlations between changes in BMI and changes in biomarker levels will be assessed via the Spearman correlation.
Measured: Baseline to up to 3 months after completion of study
Changes in insulin axis (insulin, insulin-like growth factor 1, IGF binding protein 3, homeostatic model assessment, homocystein) levels
Blood samples will be taken and representative values (mean, standard deviation, median, and range) of hormones and adipokine measurements will be used to calculate changes following intervention, which will then be used for univariate analysis using menopausal status and change in BMI as the main predictors of interest. These analyses are exploratory and descriptive of the systemic endocrine/adipokine environment; they will be related to gene expression changes. Correlations between changes in BMI and changes in biomarker levels will be assessed via the Spearman correlation.
Measured: Baseline to up to 3 months after completion of study
Changes in adipokines (leptin, adiponectin, low molecular weight adiponectin) levels
Blood samples will be taken and representative values (mean, standard deviation, median, and range) of hormones and adipokine measurements will be used to calculate changes following intervention, which will then be used for univariate analysis using menopausal status and change in BMI as the main predictors of interest. These analyses are exploratory and descriptive of the systemic endocrine/adipokine environment; they will be related to gene expression changes. Correlations between changes in BMI and changes in biomarker levels will be assessed via the Spearman correlation.
Measured: Baseline to up to 3 months after completion of study
Changes in inflammatory axis (interleukin-6, tumor necrosis factor alpha) levels
Blood samples will be taken and representative values (mean, standard deviation, median, and range) of hormones and adipokine measurements will be used to calculate changes following intervention, which will then be used for univariate analysis using menopausal status and change in BMI as the main predictors of interest. These analyses are exploratory and descriptive of the systemic endocrine/adipokine environment; they will be related to gene expression changes. Correlations between changes in BMI and changes in biomarker levels will be assessed via the Spearman correlation.
Measured: Baseline to up to 3 months after completion of study
Changes in weight
The pre- and post-intervention measures and within-individual changes in weight be summarized and examined for Normality and outliers; required transformations to achieve Normality will be performed.
Measured: Baseline to up to 3 months after completion of study
Changes in BMI
The pre- and post-intervention measures and within-individual changes in BMI will be summarized and examined for Normality and outliers; required transformations to achieve Normality will be performed. Pre-post comparisons of BMI will be performed using paired Wilcoxon signed-rank tests to evaluate changes over time, designating P < 0.05 as significant.
Measured: Baseline to up to 3 months after completion of study
Changes in breast epithelial gene expression
Gene expression for all 58 genes on the Taqman low density gene expression assays will be summarized to confirm normality and discern outliers. Each gene will then be analyzed using a linear model with the main effect of menopausal status and change in BMI, baseline gene expression and change in expression will be correlated to baseline steroid hormones and adipokines, and their change. If severe departure from normality is observed, these linear models will be applied to ranks of the data.
Measured: Baseline to up to 3 months after completion of study
Changes in parenchymal volume assessed by MRI
The volume of parenchymal enhancement on MRI will be assessed pre and post intervention in women who consent to this optional component.
Measured: Baseline to up to 3 months after completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startJul 2014
- Primary completion23 Feb 2017
- Study completion23 Feb 2017
Why it stopped: Study closed due to funding before accrual was met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Avon Foundation Center of Excellence, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Seema Khan, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154984
- Sponsor's protocol ID
- NU 13CC12
- Other IDs
- NCI-2014-01094, STU00091568, NU 13CC12, P30CA060553
- Status last verified
- Aug 2020
- First submitted
- 2 Jun 2014
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Time Restricted Diet in Obese/Overweight Pre &Amp; Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02154984
- Acronym / sponsor ID
- NU 13CC12
- Conditions
- Healthy, no Evidence of Disease, Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to funding before accrual was met
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Avon Foundation Center of Excellence, National Cancer Institute (NCI)
- Study start
- Jul 2014 (actual)
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 4 Jun 2014 (estimated)
- 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 purpose of this study is to study the relationships between obesity, hormones and menopausal status, and breast cancer. The researchers would like to study whether a type of nutritional intervention, called a time-restricted diet or tRD, is easy to maintain using a smartphone application; the researchers also want to study the effect that a tRD has on weight control, hormones, and breast tissue. A tRD is a type of diet that requires people to restrict their daily eating to a specific time frame each day. The researchers think that this might be an effective and manageable way to control weight.
Detailed description
PRIMARY OBJECTIVES:
- Feasibility of fostering adherence to self-monitoring of dietary intake using a smartphone application (app).
II. Feasibility of the goal of following a time-restricted diet.
SECONDARY OBJECTIVES:
- Identify potential molecular biomarkers and/or signatures to explore its efficacy for the normalization of metabolism.
II. Assess the systemic endocrine effects of a time restricted diet (tRD) intervention in overweight and obese pre and postmenopausal women.
III. Assess weight change following a tRD intervention. IV. Evaluate the effects of a tRD intervention, and identify a specific and reproducible genomic signature, in breast samples obtained by random fine needle aspiration in the tRD study population.
- Assess the volume of parenchymal enhancement on magnetic resonance imaging (MRI).
OUTLINE:
Participants follow a time restricted diet, which restricts daily eating to an 8 hour time window between 12:00-8:00 pm. Participants are allowed to consume non-caloric beverages (water, black tea, black coffee, diet soda, etc.) during the fasting hours and required to record daily food consumption in the smartphone app for 6 months. Participants are also coached by telephone over approximately 10-15 minutes weekly for 1 month and then biweekly for 5 months.
After completion, participants are followed up for 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral (time restricted diet) | Experimental | Behavioral: behavioral dietary intervention, Behavioral: telephone-based intervention, Other: laboratory biomarker analysisParticipants follow a time restricted diet, which restricts daily eating to an 8 hour time window between 12:00-8:00 pm. Participants are allowed to consume non-caloric beverages (water, black tea, black coffee, diet soda, etc.) during the fasting hours and required to record daily food consumption in the smartphone app for 6 months. Participants are also coached by telephone over approximately 10-15 minutes weekly for 1 month and then biweekly for 5 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subjects must have a stable weight (have not gained or lost 25 pounds in the last 6 months)
- Subjects must have had a normal mammogram within 9 months prior to registration; NOTE: subjects must also have a normal breast exam on the day of the pre-intervention random fine needle aspiration (rFNA)
- Subjects must have a body mass index (BMI) of 25-40
- Subjects must fit into ONE of the following menopausal categories:
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (7 listed)
- Subjects who have received hormonal contraception and/or hormone therapy in the past 3 months are not eligible
- Subjects who are pregnant and/or lactating are not eligible
- Subjects who are noted (upon initial online screening) to do 150 minutes or more of moderate level physical activity each week, get less than 8% of their calories from saturated fat, and eat more than 5 fruit and vegetable servings per day will not be eligible
- Subjects who are part of any structured weight loss programs (e.g. Weight Watchers, etc.) are not eligible
- Subjects who have undergone bariatric surgery are not eligible
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 |
|---|---|---|
| behavioral dietary interventionFollow tRD | Behavioural | Behavioral (time restricted diet) |
| telephone-based interventionReceive coaching calls | Behavioural | Behavioral (time restricted diet) |
| laboratory biomarker analysisCorrelative studies | Other | Behavioral (time restricted diet) |
Primary outcome
Adherence to self-monitoring
Time frame: Up to 3 months after completion of study
Assessed by demonstrating that at least 65% of participants record dietary intake on at least 80% of study intervention days. Adherence will be assessed via a one-sample chi-squared test for proportions.
Attaining the goal of dietary time restriction
Time frame: Up to 3 months after completion of study
Assessed by demonstrating that at least 65% of participants recorded appropriate time restriction on at least 80% of study days.
9 secondary outcomes
Changes in steroid hormones (estradiol, progesterone, testosterone) levels
Time frame: Baseline to up to 3 months after completion of study
Changes in gonadotropins (FSH) levels
Time frame: Baseline to up to 3 months after completion of study
Changes in insulin axis (insulin, insulin-like growth factor 1, IGF binding protein 3, homeostatic model assessment, homocystein) levels
Time frame: Baseline to up to 3 months after completion of study
Changes in adipokines (leptin, adiponectin, low molecular weight adiponectin) levels
Time frame: Baseline to up to 3 months after completion of study
Changes in inflammatory axis (interleukin-6, tumor necrosis factor alpha) levels
Time frame: Baseline to up to 3 months after completion of study
Changes in weight
Time frame: Baseline to up to 3 months after completion of study
Changes in BMI
Time frame: Baseline to up to 3 months after completion of study
Changes in breast epithelial gene expression
Time frame: Baseline to up to 3 months after completion of study
Changes in parenchymal volume assessed by MRI
Time frame: Baseline to up to 3 months after completion of study
Results and safety
The study was stopped early (reason given: Study closed due to funding before accrual was met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
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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.
Seema Khan principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral dietary intervention, telephone-based intervention and laboratory biomarker analysis in people with Healthy, no Evidence of Disease and Obesity, run by Northwestern University 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 20 inclusion and 7 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: stopped early, as of the sponsor's last update on 31 Aug 2020. 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?
The study was stopped early (reason given: Study closed due to funding before accrual was met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to self-monitoring (time frame: Up to 3 months after completion of study). 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 31 Aug 2020.