Ignite Creation Date:
2024-05-06 @ 2:54 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02154984
Status:
TERMINATED
Last Update Posted:
2020-08-31
First Post:
2014-06-02
Brief Title:
Time Restricted Diet in Obese or Overweight Pre or Postmenopausal Participants
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Pilot Study of Time Restricted Diet in ObeseOverweight Pre Amp Postmenopausal Women
Status:
TERMINATED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed due to funding before accrual was met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
I 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
I Identify potential molecular biomarkers andor 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
V 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 1200-800 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
I 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
I Identify potential molecular biomarkers andor 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
V 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 1200-800 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA060553 | NIH | Northwestern University | httpsreporternihgovquickSearchP30CA060553 |
| NCI-2014-01094 | REGISTRY | None | None |
| STU00091568 | None | None | None |
| NU 13CC12 | OTHER | None | None |