Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03785808 · ClinicalTrials.gov registry record · NA
Reducing Insulin, Growth Hormones, and Tumors
A NA study, sponsored by Fred Hutchinson Cancer Center.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT03785808 is a NA study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 3 participants.
The verdict
NCT03785808, a NA study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
The objective of this project is to compare the effect of two widely implemented cancer diets, differing drastically in macronutrient content, on biomarkers of inflammation, compared to a control diet. Diet A will be a low-carbohydrate, high-fat ketogenic-type diet with an emphasis on whole foods. By limiting carbohydrate, the diet will have an extremely low glycemic load, thereby minimizing diurnal glucose and insulin excursions. Diet B will be a low-fat, high-carbohydrate whole foods plant-based diet. It will include only fiber-rich, low-glycemic index sources of carbohydrates and largely eliminate animal protein, which will minimize rapid spikes in blood glucose and insulin and the production of IGF-1. This diet is also hypothesized to improve glucose tolerance and insulin sensitivity, which should further help minimize diurnal glycemic and insulinemic excursions. Both diets will be compared to a control diet based on the 2015 USDA Dietary Guidelines for Americans (Diet C) in patients suffering from advanced lung cancer as they are completing medical therapy. The overarching hypothesis motivating this work is that a nutrient dense diet that minimizes known factors involved in tumor growth and progression may improve the effectiveness of therapy. Our specific hypothesis is that participants following either of the experimental diets, A or B, will experience a reduction in biomarkers of insulin resistance and chronic inflammation, both of which are known risk factors for progression in lung cancer, and a greater median time to progression compared to those on the control diet (Diet C).
Interventions
- BEHAVIORAL Special Diet Therapy (low-carb)
- BEHAVIORAL Special Diet Therapy (low-fat)
- BEHAVIORAL Special Diet Therapy (USDA control)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2019-08-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03785808
The ClinicalTrials.gov registry entry for NCT03785808 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Special Diet Therapy (low-carb) is the first listed.
NCT03785808 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03785808 about?
NCT03785808 is a clinical study titled "Reducing Insulin, Growth Hormones, and Tumors". The objective of this project is to compare the effect of two widely implemented cancer diets, differing drastically in macronutrient content, on biomarkers of inflammation, compared to a control diet. Diet A will be a low-carbohydrate, high-fat ketogenic-type diet with an emphasis on whole foods. ...
What is the current status of trial NCT03785808?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2018-12-21. Estimated completion is 2019-08-05.
What interventions are being tested in trial NCT03785808?
The interventions under investigation include: Special Diet Therapy (low-carb) (BEHAVIORAL), Special Diet Therapy (low-fat) (BEHAVIORAL), Special Diet Therapy (USDA control) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03785808?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.