CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO).

Overweight and Obesity Clinical Trial

— CARE-PRO  

Official title:

The Impact of a Moderate CAlorie and Protein REstriction PROgram (CARE-PRO) as an Efficient and Affordable Therapeutic Strategy in Patients With Barrett's Esophagus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03813381
• Other study ID #: CARE-PRO
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2021

Study information

• Verified date: October 2023
• Source: Istituto Oncologico Veneto IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The increasing incidence of Esophageal Adenocarcinoma (EAC) in several Western countries can be primarily ascribed to risk factors such as obesity, chronic gastroesophageal reflux, dietary habits and alcohol intake. Nevertheless, Barrett's Esophagus (BE), remains the main risk factor for EAC. Several studies supports the role played by the gut microbiota on the modulation of metabolic and immunological pathways. An abnormal state of the microbial ecosystem seems to be involved in the promotion and onset of various diseases, including cancer. Recent studies have shown that diet and lifestyle have an important modulatory role as protective or risk factors for oncological diseases. The World Cancer Research Fund (WCRF) and the American Institute for Cancer Research (AICR) released a review of the evidence that emerged from published studies in the field of nutrition and cancer prevention and summarized their findings into 10 recommendations. Several studies have also shown that a moderate caloric and/or protein restriction seems to be able to reduce the risk of neoplastic disease development. The primary aim of this study is to evaluate the impact of a lifestyle-oriented intervention on body weight, waist circumference, biomarkers associated with cancer risk, esophageal microbiota composition and adherence to cancer prevention recommendations after 24 months in overweight or obese BE patients.

Methods and analysis: Patients are randomly divided into two arms, a control arm (CA) and an interventional arm (IA). The CA receives information about a correct lifestyle to prevent cancer.

The IA is involved in the two-year program of moderate caloric and protein restriction.

At the time of enrollment, anthropometric measurements will be recorded for each patient and they will be randomized to IA or CA. Blood samples will be obtained from each patient and blood glucose will be determined. Serum metabolic biomarkers will be measured in each serum sample and total proteins will be extracted from fresh frozen esophageal biopsy and will be analyzed to evaluate the insulin signal pathway.

To assess esophageal microbiota profiling, total genomic DNA (gDNA) will be extracted from matched fresh frozen biopsy.

In order to determine a score of adherence to cancer prevention recommendations, participants will be asked to complete a self-administrated questionnaire reflecting WCRF/AICR recommendations.

All the measurements will also occur at the end point, after two years from the enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological confirmation of Barrett's esophagus without dysplasia or cancer aged = 18 years with BMI = 25.0 kg/m^2

• Willingness and ability to perform supervised Nordic walking session twice a month and self-planned physical activity at least 3 times a week

• Signed informed consent

Exclusion Criteria:

• No histological confirmation of Barrett's esophagus

• Cancer diagnosis within one year before trial begins

• Presence of insulin-dependent diabetes

• Denied informed consent

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Calorie and protein restriction diet
Patient in intervention arm will be given individualized dietary advice on the basis of WCRF/AICR recommendations. The aim of healthy dietary advice will be the reduction of patient's total daily calorie intake up to 600 kcal below their energy requirements and 0.8g of protein/Kg body weight mostly form plant-origin food. Patients, periodically, will meet the dietitian for a 45-minute nutritional counselling session and a trained nurse for a 15-minute health coaching session. Each patient in the IA will be involved in at least three 4-hour cooking classes. Patients in the IA, after a medical/cardiac evaluation to assure their physical ability for exercise, will attend Nordic walking sessions of moderate intensity two times per month during the 24 months of intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Oncologico Veneto IRCCS

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* Note: There are 58 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight change	A 7% weight loss	Baseline and after 24 months
Secondary	Metabolic serum biomarkers	Fasting glucose (mg/dl)	Baseline and after 24 months
Secondary	Metabolic serum biomarkers	Insulin (pg/ml) and C-peptide (pg/ml), tumor necrosis factor-alpha -TNF-alpha (pg/ml) and Interleukin-6 - IL-6 (pg/ml).	Baseline and after 24 months
Secondary	Metabolic serum biomarkers	Insulin-like growth factor - IGF1 (nmol/ml), insulin-like growth factor binding protein 1 and 3 - IGFBP1 (nmol/ml) and IGFBP3 (nmol/ml)	Baseline and after 24 months
Secondary	Metabolic serum biomarkers	Leptin (ng/ml)	Baseline and after 24 months
Secondary	Metabolic serum biomarkers	Adiponectin (µg/ml)	Baseline and after 24 months
Secondary	Insulin resistance index (HOMA-IR)	HOMA-IR index [fasting plasma glucose (mg/dl) × fasting serum insulin(µU/ml)/405]	Baseline and after 24 months
Secondary	Expression of proteins involved on insulin and IGF1 receptors signal transduction	Phosphoinositide 3-kinases (PI3K)/Protein kinase B(Akt) pathway; mitogenic (ERK/MAPK) pathway	Baseline and after 24 months
Secondary	Esophageal microbiota composition	To assess esophageal microbiota profiling, total gDNA will be extracted from fresh frozen biopsy. Specific primers for the bacterial V3-V4 hypervariable regions of 16S ribosomal ribonucleic acid (rRNA) will be used to amplify bacterial DNA [˜ 500 bases pair (bp)] to be sequenced by Illumina Miseq platform with 300 bp paired-end approach.	Baseline and after 24 months
Secondary	Adherence score to World Cancer Research Fund and the American Institute for Cancer Research (WCRF/AICR) recommendations for cancer prevention.	In order to determine a score of adherence to cancer prevention recommendations, participants will be asked to complete a 6-item self-administrated questionnaire reflecting six recommendations provided by the World Cancer Research Fund and the American Institute for Cancer Research (WCRF/AICR).; A score of 1 will be assigned when the item is met and a score of 0 will be assigned when it is not. An answer that partially satisfies the item will be assigned a score of 0.5. Some recommendation (item) have sub-item (item 3,4 and 5). Even for sub-item the score will be 1-0 with 0.5 for partially satisfied item. For total score of item presenting sub-item, we will consider the score obtained by calculating the average score between the sub-item.; The final adherence score will derive from the mathematical sum of the individual scores obtained for each item. The maximum expected score will be equal to 6 (full adherence).	Baseline and after 24 months
Secondary	Waist circumference reduction	Waist circumference (cm)	Baseline and after 24 months

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