Effect of a Carbohydrate-rich Diet in Healthy Subjects (AGL9)

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

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.

Study Overview

• Status: Completed
• Conditions: Lipid Metabolism Disorder
• Intervention / Treatment: Dietary supplement: isocaloric diet; Other: Liquid meal; Radiation: PET imaging; Other: perfusions of stable tracers; Device: Indirect calorimetry; Dietary supplement: Hypercaloric diet

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre de recherche du CHUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Isocaloric diet (7 days); Protocole A	Dietary supplement: isocaloric diet; a 7-day isocaloric diet; Other: Liquid meal; Radiation: PET imaging; Other: perfusions of stable tracers; Device: Indirect calorimetry
Experimental: Hypercaloric diet enriched with carbohydrate food (7 days); Protocole B	Other: Liquid meal; Radiation: PET imaging; Other: perfusions of stable tracers; Device: Indirect calorimetry; Dietary supplement: Hypercaloric diet; A 7-day hypercaloric diet supplemented with carbohydrate-rich food (+ 50% of the subject's energy needs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cardiac and hepatic oxidative metabolism index	will be determined using 11C-acetate PET/CT followed by a 30 minutes dynamic PET acquisition.	2 months
Cardiac and hepatic blood flow	will be determined using 11C-acetate PET/CT followed by a 30 minutes dynamic PET acquisition..	2 months
metabolites appearance rate	will be determined by perfusion of stable isotope tracers	6 months
energy metabolism (whole body production)	by indirect calorimetry	4 months
hormonal responses	analysed by colorimetric and Elisa tests	4 months
Insulin sensitivity	will be determined using the HOMA-IR (based on fasting insulin and glucose) levels	4 months
Insulin secretion rate	will be assessed using deconvolution of plasma C-peptide with standard Cpeptide kinetic parameters	4 months
β-cell function	will be assessed by calculation of the disposition index (DI) that is insulin secretion in response to the ambient insulin	4 months
Anthropometric parameters	will be measured at each postprandial metabolic study	2 months

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Hospices Civils de Lyon
• Investigators: Principal Investigator: André Carpentier, Université de Sherbrooke

Publications and helpful links

General Publications

• Montastier E, Ye RZ, Noll C, Bouffard L, Fortin M, Frisch F, Phoenix S, Guerin B, Turcotte EE, Lewis GF, Carpentier AC. Increased postprandial nonesterified fatty acid efflux from adipose tissue in prediabetes is offset by enhanced dietary fatty acid adipose trapping. Am J Physiol Endocrinol Metab. 2021 Jun 1;320(6):E1093-E1106. doi: 10.1152/ajpendo.00619.2020. Epub 2021 Apr 19.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2013
• Primary Completion (Actual): March 20, 2019
• Study Completion (Actual): July 2, 2019

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: 2013-530, 12-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No