Clinical trial · Interventional
Reducing Insulin, Growth Hormones, and Tumors
The Impact of Diet Quality on Biomarkers Associated With Lung Cancer Outcomes: Reducing Insulin, Growth Hormones, and Tumors (RIGHT Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to lack of accrual/enrollment
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diet Modification | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Special Diet Therapy (low-carb) | Behavioral | — | UNRESOLVED |
| Special Diet Therapy (low-fat) | Behavioral | — | UNRESOLVED |
| Special Diet Therapy (USDA control) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Diet A (low carbohydrate)
- description
- Dietary Intervention A will be a low-carbohydrate/high fat, ketogenic-type diet. The diet will include salads, leafy green and non-starchy vegetables, nuts and seeds, eggs, fish and shellfish, and meats in most meals. Grains and added sugars will be excluded, and starchy vegetables, fruits, berries, and legumes will be limited to below 10% of total calorie intake. In addition full fat yogurt, cheeses, and butter will be allowed in moderate amounts. Participants will be encouraged to eat freely from whole-foods rich in fats such as avocados, nuts, seeds, olives, coconut and to use coconut, medium-chain triglyceride (MCT), olive, and avocado oils for cooking and baking on that diet. Participants will aim to fulfill at least 65% of their total calorie requirements from fats.
- interventionNames
- Behavioral: Special Diet Therapy (low-carb)
- type
- EXPERIMENTAL
- label
- Diet B (low fat)
- description
- Dietary Intervention B will be low-fat, high carbohydrate whole-foods, plant-based diet. Most animal products and concentrated plant-based protein sources (such as soy isolates) will be excluded. Whole grains, particularly in their cooked form, legumes, vegetables, and fruits will be encouraged while excluding added sugars and refined grains. Added fats and oils will be discouraged on this diet as dietary fat should comprise less than 10% of total energy. Participants can eat freely from all types of fruits, vegetables, and cooked whole grains. Legumes will be emphasized as a replacement for meat and dairy products. Proteins similar to beef, pork, poultry, and dairy products, should be strictly limited, while lean proteins such as eggs, fish, and shellfish may be included occasionally.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults (18 years or older) receiving treatment at the Seattle Cancer Care Alliance (SCCA) * Stage IIIB and IV non-small cell adenocarcinoma or squamous cell carcinoma, or small cell lung cancer with advanced disease receiving therapy with systemic treatment * Body mass index (BMI) \>= 20 kg/m\^2 * Body weight within 10% of current weight within the 3 months before starting the study * Able and willing to attend bi-weekly dietary support sessions at the Seattle Cancer Care Alliance (SCCA) during the initial 12-week intervention period * Willing and able to follow the dietary regimen * Willing to maintain usual lifestyle habits (other than diet) throughout the study (e.g., physical activity habits) * Ability to understand, speak, and write in English * Ability to provide informed written consent Exclusion Criteria: * Neuroendocrine large cell carcinoma or atypical carcinoids with metastatic disease * Small cell lung cancer receiving curative therapy with radiation * Use of antidiabetic medications or insulin within the last 6 months * Presence of grade 2 weight loss, cachexia, and/or severe nausea * Current participation in therapeutic first line trial * Alcohol intake \> 2 drinks per day * Major dietary restriction, as determined by the researcher * Other significant health condition as determined by the researcher
References
Publications (0)
Data not yet available