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NCT01315483 · ClinicalTrials.gov registry record · NA
Diet Composition, Weight Control, and Breast Carcinogenesis
A NA study, sponsored by Colorado State University.
- Completed
- Registry status
- NA
- Development phase
- 259
- Enrollment target
NCT01315483: Completed NA study, sponsored by Colorado State University.
NCT01315483 is a NA study that has completed, run by Colorado State University. The registered enrollment target is 259 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01315483, a NA study, has completed, sponsored by Colorado State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 259 participants
- Enrollment target
Study Summary
In the United States, overweight (BMI \> 25 but \< 30 Kg/m2) and obesity (BMI \> 30Kg/m2) are increasing at epidemic rates. A significant association exists between being overweight or obese and breast cancer recurrence and survival. However, evidence continues to accumulate indicating that achieving or maintaining a healthy weight for height (Body Mass Index, BMI, 18.5-25Kg/m2) is associated with a reduced risk for breast cancer and with a decrease in breast cancer associated mortality. Despite this, there is a lack of randomized controlled trials exploring this association and how the process of fat loss or being successful in actually reaching a healthy weight for height differentially affects biomarkers for cancer recurrence. Many dietary approaches for weight loss are currently available to the public, and each purports to offer advantages. However, there is little scientific evidence to indicate how these dietary approaches, some of which vary markedly in the foods that they limit or exclude, affect biomarkers for breast cancer risk. In particular, it is not know whether the critical factor in relation to weight and breast cancer is simply weight loss (negative energy balance), irrespective of the manner in which it is achieved, or if certain dietary approaches affect breast cancer risk biomarkers more favorably than others. Published data from our laboratory suggest that dietary pattern does matter, and therefore the goal of this study is to investigate the effects of two popular weight loss dietary approaches that differ in the extent to which they limit carbohydrate or fat consumption (with effects on dietary glycemic load) compared to a usual care group on prognostic markers for cancer recurrence in postmenopausal breast cancer survivors. The investigators hypothesize that in addition to the anticipated effects of fat loss on circulating levels of bioavailable sex steroid hormones, that the effects of excess fat on breast cancer prognosis can be attribute
Primary Outcome
C-reactive protein, IL-6, TNF-alpha
Interventions
- OTHER Weight Loss Dietary Pattern
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-06 |
| Phase | NA |
What the finished NCT01315483 record still lists
NCT01315483 is an interventional study that assigns participants to a tested intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Weight Loss Dietary Pattern is the first listed.
NCT01315483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01315483 about?
NCT01315483 is a clinical study titled "Diet Composition, Weight Control, and Breast Carcinogenesis". In the United States, overweight (BMI \> 25 but \< 30 Kg/m2) and obesity (BMI \> 30Kg/m2) are increasing at epidemic rates. A significant association exists between being overweight or obese and breast cancer recurrence and survival. However, evidence continues to accumulate indicating that achievin...
What is the current status of trial NCT01315483?
This trial is currently completed. It is a NA study. The enrollment target is 259 participants. The study started on 2008-09. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01315483?
The interventions under investigation include: Weight Loss Dietary Pattern (OTHER).
Who is sponsoring clinical trial NCT01315483?
This trial is sponsored by Colorado State University, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01315483's enrollment target sits among peer trials
259 400th of 2000 higher than 1,599 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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