The experimental arm (N=15) will be given a CRHF diet for 2 weeks neoadjuvantly (during radiotherapy preparation) and adjuvantly during primary oncology treatment for ~6.5 weeks. The CRHF diet will be composed of 45% unsaturated fats, 25% proteins, and 30% carbohydrates.

The control arm (N=15) will receive standard of care including a well-balanced diet, prescribed with enough calories/proteins to maintain body weight for approximately 2 weeks (during radiotherapy preparation) followed by standard treatment for ~6.5 weeks.

Head and Neck Squamous Cell Carcinoma

Calorie needs will be calculated as 25 - 35 kcals/kg ABW to maintain body weight before and during treatment.
Fluid needs will be calculated as 25-35 ml/kg ABW.
Sources of macronutrients:
Carbohydrates: from whole grains, dairy products, legumes, fruits, and vegetables.
Fats: from mono- and polyunsaturated fatty acids, including medium- and long-chain fatty acids.
Proteins: plant-based proteins and lean animal-based proteins. All meals will be provided to the participants throughout the study period and the diet will be provided orally unless the patient is on a feeding tube or a feeding tube is ordered by a physician during the study period. Diet texture will be according to patients chewing and swallowing abilities. If the patient is on a feeding tube or intake is insufficient, a formula with similar macronutrient composition + a protein supplement used at the AVH will be provided.

Carbohydrate-restricted, high-fat diet

The usual diet will contain approximately 50% carbohydrates, 17% proteins, and 33% fats

Usual Dietary Care

Augusta Victoria Hospital

Feasibility of a Carbohydrate-restricted, High-fat Diet on Head and Neck Squamous Cell Carcinoma Outcomes

Feasibility of a Carbohydrate-restricted, High-fat Diet to Improve Outcomes in Head and Neck Squamous Cell Carcinoma: A Pilot Randomized Controlled Feeding Trial

Recruitment will be measured by recording the number of patients screened, included, excluded, dropped-out, and completed the study throughout the study period.

Adherence will be measured by collecting daily food surveys that ask about daily food intake (checking the food items that have been consumed and providing information about any other additional foods that were consumed) as well as completing all study activities which are listed on a checklist.

Retention will be measured by recording the number of patients included or agreed to participate and completed all study protocol.

We will be recording whether blood glucose is normal or abnormal.

We will be recording whether CBCs are normal or abnormal.

We will assess whether liver function will remain normal after consuming the diet or not. That will be done by measuring the levels of GOT, GPT, and alkaline phosphatase in the blood and recording whether they are normal or not.

We will assess whether kidney function will remain normal after consuming the diet or not. That will be done by measuring the levels of BUN, creatinine, and uric acid in the blood and recording whether they are normal or not.

We will be recording whether serum electrolytes are normal or abnormal

We will be recording whether albumin in the blood is normal or abnormal

We will be recording whether CRP level in blood is normal or not. High level indicates inflammation.

We will be assessing the level of total proteins in the blood and recording whether it is normal or not.

We will be assessing the level of insulin in the blood and recording whether it is normal or changed after consuming the diet.

We will be recording whether level of triglycerides in the blood is normal or not.

We will be recording whether level of total cholesterol in the blood is normal or not.

We will be recording whether level of LDL-cholesterol in the blood is normal or not.

We will be recording whether level of HDL-cholesterol in the blood is normal or not.

Tumor progression will be assessed using RECIST and WHO criteria as well as diagnostic CTScan/ PETScan imaging.

Nutritional status will be assessed using the "Patient generated subjective global assessment" (PG-SGA) tool.

Using a Bioelectric Impedance Analysis (BIA) device to study the effect of the intervention on body composition. Lean Body Mass%, Body Water %, Average Daily Calorie Requirement

Using a Bioelectric Impedance Analysis (BIA) device to study the effect of the intervention on body composition.

Quality of life will be assessed using EORTC QLQ questionnaires.

Symptom burden will be assessed using the validated Memorial Symptom Assessment Survey.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Anna Arthur

Assistant Professor

University of Illinois at Urbana-Champaign

Augusta Victoria Hospital, East Jerusalem

Participants will be blinded from the group they are assigned to.

Participants received experimental test meal first and placebo comparator meal at the next study visit. Participants to fill out visit questionnaire prior to meal and every 30 minutes thereafter for 5 hours. Samples of ileostomy fluid taken at these time-points, along with blood samples in a subset of participants

Participants received placebo comparator meal first and experimental test meal at the next study visit. Participants to fill out visit questionnaire prior to meal and every 30 minutes thereafter for 5 hours. Samples of ileostomy fluid taken at these time-points, along with blood samples in a subset of participants

Obesity

100g Alginate Bread, toasted with 20g of butter.

Alginate Bread

100g standard White Bread (control), toasted with 20g of butter.

Control Bread

Bioactive Dietary Fibres and Obesity

The Impact of Dietary Fibres on Pancreatic Lipase Activity and Gastrointestinal Function

Measurement in grams of total lipid in ileal effluent every 30 minutes after test meal consumption

Using VAS score from the well being questionnaire

Measured in micro-molar of triacylglycerol (TAG) every 30 minutes after test meal consumption

There is not a plan to make IPD available.

Newcastle-upon-Tyne Hospitals NHS Trust

Biotechnology and Biological Sciences Research Council

Placebo, controlled double-blind crossover study will recruit participants (males and females, who have previously had ileostomy surgery, but currently have no health issues) from the Newcastle upon Tyne/Gateshead area. Subjects will be randomly allocated to one of two treatment groups. One group will receive a test meal containing the dietary fibre first, then on the second visit, the same meal without dietary fibre. The second group will receive the meal without dietary fibre first, followed by the meal containing dietary fibre on the second visit. For each group, the two visits will be at least 2 weeks apart. As the foods will look exactly the same (the fibres used are colourless and tasteless). As it necessary in double-blind crossover studies, neither the researchers nor the participants will know which food they are receiving at each visit. All randomisation will be carried out in anonymised fashion by an independent researcher, who will code foods and participants accordingly.

As it necessary in double-blind crossover studies, neither the researchers nor the participants will know which food they are receiving at each visit. All randomisation will be carried out in anonymised fashion by an independent researcher, who will code foods and participants accordingly.

Patients will undergo an MRI for assessment of the fat content of the liver. Then during surgery, their livers will be illuminated (for a few seconds) by Raman spectroscope (the device in question) to see if MRI findings correlate well with Raman spectroscopy findings.

Steatosis

Liver will be illuminated by the Raman spectroscope optic probe in order to assess fat content

victoria/carbohydrate

Feasibility of a Carbohydrate-restricted, High-fat Diet on Head and Neck Squamous Cell Carcinoma Outcomes

Bioactive Dietary Fibres and Obesity

Clinical Validation of a Raman Spectroscope to Determine Hepatic Fat Content

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