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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: Clinical Trial NA study, sponsored by Fred Hutchinson Cancer Center.
NCT03785808 is a NA study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To compare the impact of consuming the three study diets for 24 weeks on the pro-inflammatory mediator IL-6, which is associated with lung cancer progression.
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 |
Why NCT03785808 stopped before completion
NCT03785808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which Special Diet Therapy (low-carb) is the first listed.
NCT03785808 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03785808's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 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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