Effect of a Carbohydrate-rich Diet in Healthy Subjects

Lipid Metabolism Disorder Clinical Trial

— AGL9  

Official title:

The Relative Contribution of Dietary Lipids vs. of Fatty Acids to Non-adipose Tissues and the Effect of a Carbohydrate-rich Diet in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04088344
• Other study ID #: 2013-530, 12-201
• Status: Completed
• Phase: N/A
• Start date: April 10, 2013
• Est. completion date: July 2, 2019

Study information

• Verified date: September 2019
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present research protocol will analyze whether a short-term modification (one week) of dietary habits would have an impact on the postprandial metabolism of dietary fatty acids and on their uptake by non-adipose tissues, in healthy subjects.

Each subject will participate in two protocols randomly determined and separated by a period of one month: a 7-day isocaloric diet (Protocol A) and a 7-day carbohydrate-rich diet containing +50% of the subject's energy needs. (Protocol B).

At the end of each diet, the subject will go through a postprandial metabolic study of 8 hours where different parameters will be measured thanks to PET imaging and perfusions of stables isotopes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Healthy subjects: subjects with normal glucose tolerance determined according to an oral glucose tolerance test and with a BMI above 25 kg/m2 without first degree of familial history of type 2 diabetes (parents, siblings).

Exclusion Criteria:

• overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG

• treatment with a fibrate, thiazolidinedione, beta-blocker or other drug known to affect lipid or carbohydrate metabolism (except statins, metformin, and other antihypertensive agents that can be safely interrupted)

• presence of liver or renal disease, uncontrolled thyroid disorder, previous pancreatitis, bleeding disorder, or other major illness

• smoking (>1 cigarette/day) and/or consumption of >2 alcoholic beverages per day

• prior history or current fasting plasma cholesterol level > 7 mmol/l or fasting TG > 5 mmol/l

• any other contraindication to temporarily interrupt current meds for lipids or hypertension

• being pregnant

• not be barren

Related Conditions & MeSH terms

• Lipid Metabolism Disorder
• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Dietary Supplement:
• isocaloric diet
a 7-day isocaloric diet
• Hypercaloric diet
A 7-day hypercaloric diet supplemented with carbohydrate-rich food (+ 50% of the subject's energy needs).

Other:
• Liquid meal

Radiation:
• PET imaging

Other:
• perfusions of stable tracers

Device:
• Indirect calorimetry

Locations

Country	Name	City	State
Canada	Centre de recherche du CHUS	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Hospices Civils de Lyon

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	whole-body organ-specific Dietary Fatty Acid (DFA) partitioning	will be determined by whole-body CT (16 mA) followed by PET acquisition of 18FTHA	2 months
Primary	Left ventricular function by Positron Emiting Positron (PET) ventriculography	will be determined using 11C-acetate PET/CT. 180 MBq will be administered by bolus injection at fasting. After a transmission scan and regional CT (40mA), a 30-min dynamic list-mode PET acquisition will be performed on a 18 cm-high thoraco-abdominal segment to include the left cardiac ventricle and most of the liver on a Philips Gemini TOF PET/CT	2 months
Secondary	Cardiac DFA uptake	will be assessed using PET/CT method with oral administration of 18FTHA followed by a 30 min. dynamic PET acquisition	2 months
Secondary	Cardiac and hepatic oxidative metabolism index	will be determined using 11C-acetate PET/CT followed by a 30 minutes dynamic PET acquisition.	2 months
Secondary	Cardiac and hepatic blood flow	will be determined using 11C-acetate PET/CT followed by a 30 minutes dynamic PET acquisition..	2 months
Secondary	metabolites appearance rate	will be determined by perfusion of stable isotope tracers	6 months
Secondary	energy metabolism (whole body production)	by indirect calorimetry	4 months
Secondary	hormonal responses	analysed by colorimetric and Elisa tests	4 months
Secondary	Insulin sensitivity	will be determined using the HOMA-IR (based on fasting insulin and glucose) levels	4 months
Secondary	Insulin secretion rate	will be assessed using deconvolution of plasma C-peptide with standard Cpeptide kinetic parameters	4 months
Secondary	ß-cell function	will be assessed by calculation of the disposition index (DI) that is insulin secretion in response to the ambient insulin	4 months
Secondary	Anthropometric parameters	will be measured at each postprandial metabolic study	2 months