Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

All Drugs and Chemicals

Androgens

Testosterone

Meal Composition

Richard S Legro, M.D.

The primary objective is to determine if meals of different fat and fiber content affect postprandial plasma testosterone concentration in women with polycystic ovary syndrome. Our hypothesis is that a high-fiber meal will have a greater reduction in testosterone composition compared with a high-fat meal.

The study participants are 15 women with PCOS between the ages of 19-40. All participants must be in good health, non-smokers, and not pregnant or lactating. For three days prior to both study visits, participants follow a standard 2,000 calorie meal plan of approximately 30% fat, 55% carbohydrate and 15% protein. On the morning of the two study visits, participants arrive at the General Clinical Research Center at 0700 h. A venicatheter is inserted into an antecubital vein for collection of blood samples and the catheter is kept open with saline. A baseline blood sample is taken for measurement of estradiol, progesterone, glucose, insulin, testosterone, and sex hormone binding globulin (SHBG). Participants are then served the test meal and asked to consume it within 15 minutes. The high-fat, low-fiber and low-fat, high-fiber meals are isocaloric and are 62% and 6% fat, 24% and 81% carbohydrate, and have 1g and 26.8g of fiber, respectively. After each meal, a blood sample is taken at 30 minutes and every hour for six hours for measurement of testosterone, SHBG, glucose and insulin. During this time participants remain comfortably seated or reclined. After the last blood draw, the catheter was removed and participants are given a complementary meal.

Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome

The Effect of Meals of Varying Fat and Fiber Content on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nervous System Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Amino Acids

Caseins

Phenylalanine

Leucine

A liquid mixed meal are gived adjusted by weight. The meal consists of: Intrinsically labelled D5-Phenylalanine and D3-Leucine labelled casein protein, 13C16palmitate, 13C6-Glucose in a mix of glucose, casein protein and rape seed oil dissolved in water in an energy density of 50% CHO, 35% fat and 15% protein. Blood samples are drawn frequently to measure fat, glucose and protein metabolism.

Meal

Mette Cathrine Ørngreen, MD, DMSc

At the center of pediatric oncology in Copenhagen the investigators experience that the children with brain tumor, more or less have a healthy body with normal skeletal muscle mass and are physical active to the same level as their friends at the same age. The treatment period for brain tumor is approximately two years. After the treatment period, the children are more sedative with less interest in coming out doing physical activities and thus the investigators suspect that they have altered hormonal response, low skeletal muscle mass and perhaps are in risk of developing metabolic syndrome.

By comparing children with newly diagnosed CNS tumor with children finished treated for CNS tumor, we wish to describe the metabolic path during the approximately two years treatment period these children go through. These results will also be compared with results from healthy controls.

The investigators aim to include 10 children (aged 6-18 years) with newly diagnosed CNS tumor, 10 children (aged 6-18 years) finished treated for CNS tumor and 10 healthy controls (aged 6-18 years). By using stable isotope technique the investigators will investigate systemic fat, glucose and protein metabolism together with liver protein degradation and glucose production. Furthermore, by using DXA scan the investigators will describe the quality and distribution of skeletal muscle. Lastly, the investigators will determine the skeletal muscle signal pathway and metabolism in skeletal muscle via the Bergström biopsy technique in vastus lateralis.

By comparing children with newly diagnosed CNS tumor with children finished treated for CNS tumor, the investigators wish to describe the metabolic path during the approximately two years treatment period these children go through. These results will also be compared with results from healthy controls.

Trial design and time frame:

A prospective, non-randomized, cross-sectional study.

There will be three different patient groups included:

* Patient group A: Children with newly diagnosed CNS tumor
* Patient group B: Children finished treated for CNS tumor
* Healthy controls: Children admitted to the hospital at the Epilepsy monitor unit (EMU)

The trial will be conducted over a total of two days and takes place at the Department of Pediatrics and Adolescent Medicine, Rigshospitalet and the Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet.

* Study day 1: Is estimated to last approximately 2 hours.
* Study day 2: Is estimated to last approximately 8 hours.

Study Day 1: The children will be DXA-scanned and complete life quality questionnaires and pain scores. In some cases, study day 1 will be done after study day 2, depending on the cancer treatment plan for each patient.

Study Day 2: For the patients newly diagnosed with CNS tumor: The investigators strive to conduct study day 2 within the first week of hospital admission due to newly diagnosed CNS tumor. However, the investigators do accept study day 2 being conducted within the first month after time of diagnose.The subjects will arrive around 08.00, at Copenhagen Neuromuscular Centre (CNMC), Rigshospitalet.

On arrival, EMLA (local anesthetics cream) will be applied on the skin of the children in order to minimize any discomfort that may occur during iv-insertion. Two peripheral venous catheters are inserted, one in the medial cubital vein for infusion of stable isotopes, and one in a dorsal vein of the hand for blood sampling. If the child has a central venous catheter (CVK), we will only insert one peripheral venous catheter, in the medial cubital vein for infusion of the stable isotopes.

After 1 hour and 45 minutes of basal tracer infusion, basal blood samples are drawn (time -15 and 0) for the determination of basal steady state tracer enrichments and hormone concentrations. At time= 0, a liquid mixed meal is provided. Blood samples are drawn frequently for 6 hours relative to start of the test meal (at 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240, 300 and 360 minutes)\[24\], \[25\]. If the child becomes upset or we for other reasons want to stop earlier than 6 hours, we will use the already obtained results.

The tracers: In this study, the investigators will intravenously infuse small amounts of metabolites labelled with stable isotopes in primed continuous intravenous infusions of: D8-Phenylalanine, D2-Tyrosine, 13C18-Oleate acid, D2-Glucose, D5-Glycerol. This method is well-established at both CIMT and CNMC and has been used investigating several of patients categories before: Neonates (ongoing study), gastric sleeve, elderly and neuromuscular patients.

The tracers are prepared from the hospital pharmacy. All tracers are purchased from Cambridge Isotope Laboratories, Andover, MA, USA suitable for human use. Stable isotopes are non-radioactive and naturally occurring in food (e.g. in corn).

Food intervention: At time= 0 (120 minutes after infusion), a liquid mixed meal adjusted by weight is given. The meal consists of: Intrinsically labelled D5-Phenylalanine and D3-Leucine labelled casein protein, 13C16palmitate, 13C6-Glucose in a mix of glucose, casein protein and rape seed oil dissolved in water in an energy density of 50% CHO, 35% fat and 15% protein. Intrinsically labeled caseinate was produced via an infusion of \[D5\]-phenylalanine and \[D3\]leucine into a lactating cow to obtain enriched milk Foulumn, Arhus University, from which the caseinate fraction was isolated at Arla Foods according to Good Manufacturing Practice (GMP) and safety checked an store under appropriate regulatory conditions until use (Nørre Vium, Denmark) following a previously described procedure.

Analyses of blood samples:The samples will be collected in syringes containing 10μL EDTA/mL to prevent coagulation. The blood is immediately centrifuged at 4oC to separate plasma from red blood cells. The samples will be frozen in coded tubes and stored at -80C until analysis.

Routine blood samples: Will be analysed immediately at the Department of Clinical Biochemistry, Rigshospitalet:

- Blood samples include: Insulin, HbA1C, Cholesterol, HDL, LDL, triglycerides

Glucose and lactate: will be analyzed (ABL 700) immediately as the blood is drawn.

Specific blood samples:

* Free fatty acids: will be analyzed using fluorometry.
* Hormones (catecholamines, insulin, incretins and glucagon): will be analyzed using RIA and Elisa Methods respectively.
* Stable isotope enrichments in blood: will be analyzed using Liquid chromatography-tandem mass-spectrometry (LC-MS/MS) and gas chromatography combustion isotope ratio mass spectrometry (GC-C-IRMS) (Thermo Scientific, Palo Alto, CA, USA and Bremen, Germany).

Calculations: Whole body metabolite quantitative kinetics will be calculated using Steele's equation for non-steady state adapted for analysis of stable isotopes under the post-absorptive conditions.

Whole Body Metabolism in Children Before and After Treatment of CNS Tumor

Phenylalanine Rate of appearance micro mol/kgFFM/min

Phenylalanine Rate of disappearance micro mol/kgFFM/min

Nutritional, meal, absorption kinetics of proteins, carbohydrates and fat including first bypass losses (interstitial and liver). In case of fat that included synthesis rates of chylomicrons and their breakdown rate by determining the overflow of the nutritional fatty acids into the main circulation.

Dual-energy X-ray absorptiometry (DEXA) scan

Blood, mainly liver, proteins synthesis rate and liver function parameter from, A. liver glucose; B. VLDL-TAG production rate; C. phenylalanine hydroxylation rates

Life quality score by using PedsQL (0-100)

Muscle morphology, muscle fiber type and size, atrophy protein markers (MuRF1, MAFbx, FoxO) muscle generating markers (Myo D, Myogenin, IGF1), muscle growth regulating protein (myostatin).

HDL , LDL, total cholesterol, TAG (mmol/L)

Rigshospitalet, Denmark

Principal Investigator

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Cola

Moderate intensity physical effort and meal (once)

Low intensity physical effort and meal (visit 1, day of cycle 1 chemotherapy) and low intensity physical effort (visit 2, day of cycle 2 chemotherapy)

Pedaling 15 minutes at 75 Watt then 100 Watt of the ergometer

Moderate intensity physical effort

Pedaling 3 minutes at the 30 Watt level of the ergometer

Low intensity physical effort

Eating an hyperlipidic meal 60 minutes after a physical effort

Hyperlipidic meal

Multiple measure of circulating DNA: on an empty stomach, at the end of the physical effort, after 15, 30 and 60 minutes of rest, 120 minutes after an hyperlipidic meal.

An additional measure will occur for subjects free of malignancy during the effort.

Measure of circulating DNA

Annie BERGERA

Pierre LAURENT-PUIG, MD-PHD

Pierre LAURENT-PUIG, MD-PhD

The study of circulating tumoral DNA makes it possible to study, without invasive procedures or pathological studies, the tumoral DNA circulating in the blood of a patient and its various alterations. In patients with colon-rectal cancer with resected tumor, circulating tumor DNA can be used as a predictive biomarker of metastatic relapse of cancer. However, the routine extension of circulating tumoral DNA remains limited due to several difficulties. One of the pifalls that circulating tumor DNA is greatly diluted by healthy circulating DNA from non-tumor cells. The amount of healthy circulating DNA has been described as being influenced by certain physiological parameters. The aim of the study is to increase knowledge on the influence of physiological factors associated with sports activity and meal on the release kinetics of circulating DNA.

20 subjects free of malignancy (Male-Female Ratio 2 to 1) the variation in the concentration of DNA circulating between the value measured on an empty stomach after 1 hour of rest, then at the end of each of the successive stages of moderate intensity physical effort: pedaling 15 minutes at 75 Watt then 100 Watt of the ergometer. Dosages will be repeated after 15, 30 and 60 minutes of recovery. After an hour of recovery, the subject will be asked to consume a meal rich in fat. The circulating DNA will be measured 2 hours after the end of the meal.

40 patients with colon cancer will be enrolled for a two visit study. The first visit will be planned at the first cycle of chemotherapy, before the chemotherapy. At this visit, the influence of exercise on plasma concentrations of circulating free DNA will also be studied in 40 patients with colon cancer. Free circulating DNA will be measured on an empty stomach after 1 hour of rest, then immediately after low-intensity physical effort : pedaling 3 minutes at the 30 Watt level of the ergometer) and after 15, 30 and 60 minutes of recovery. After an hour of recovery, the subject will be proposed to consume a meal rich in fat. The circulating DNA will be measured 2 hours after the end of the meal. The second visit will be planned at the first second of chemotherapy, before the chemotherapy. Free circulating DNA will be measured on an empty stomach after 1 hour of rest, then immediately after low-intensity physical effort : pedaling 3 min at the 30 Watt level of the ergometer, and after 15, 30 and 60 minutes of recovery.

Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects

Impact of Sport Practice and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects. Physiological Pilot Study

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Variation in the concentration of circulating DNA between the value measured after 1 hour of rest, during and at recovery of moderate intensity physical effort

Variation in the concentration of circulating DNA between the value measured before and after an hyperlipidic meal in subjects free of malignancy

Variation in the concentration of circulating DNA between the value measured after 1 hour of rest, during and at recovery of low intensity physical effort

Variation in the concentration of circulating DNA between the value measured before and after an hyperlipidic meal

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome	NCT00455338	Polycystic Ovar...	Meal Compositio...	19 Years - 40 Years	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Whole Body Metabolism in Children Before and After Treatment of CNS Tumor	NCT06380387	CNS Tumor, Chil...	Meal	6 Years - 18 Years	Rigshospitalet, Denmark
Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects	NCT05147545	Colon Cancer	Moderate intens... Low intensity p... Hyperlipidic me... Measure of circ...	18 Years - 85 Years	Assistance Publique - Hôpitaux de Paris
Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome	NCT00455338	Polycystic Ovar...	Meal Compositio...	19 Years - 40 Years	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Spots Global Cancer Trial Database for meal

Every month we try and update this database with for meal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for meal

Every month we try and update this database with for meal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for meal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.