Effect of a Carbohydrate-rich Diet in Healthy Subjects

Not Applicable

Completed

• Conditions: Lipid Metabolism Disorder
• Interventions: Dietary Supplement: isocaloric diet; Dietary Supplement: Hypercaloric diet; Other: Liquid meal; Radiation: PET imaging; Other: perfusions of stable tracers; Device: Indirect calorimetry

• Registration Number: NCT04088344
• Lead Sponsor: Université de Sherbrooke

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-10
• Primary Completion: 2019-03-20
• Study Completion: 2019-07-02
• Status Verified: 2019-09
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-11
• Last Update Submitted: 2019-09-11
• Study First Posted: 2019-09-12
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Isocaloric diet (7 days)	PET imaging	Protocole A
Isocaloric diet (7 days)	Indirect calorimetry	Protocole A
Hypercaloric diet enriched with carbohydrate food (7 days)	Indirect calorimetry	Protocole B
Isocaloric diet (7 days)	isocaloric diet	Protocole A
Isocaloric diet (7 days)	perfusions of stable tracers	Protocole A
Hypercaloric diet enriched with carbohydrate food (7 days)	Hypercaloric diet	Protocole B
Hypercaloric diet enriched with carbohydrate food (7 days)	Liquid meal	Protocole B
Isocaloric diet (7 days)	Liquid meal	Protocole A
Hypercaloric diet enriched with carbohydrate food (7 days)	PET imaging	Protocole B
Hypercaloric diet enriched with carbohydrate food (7 days)	perfusions of stable tracers	Protocole B

Primary Outcome Measures

Name	Time	Method
whole-body organ-specific Dietary Fatty Acid (DFA) partitioning	2 months	will be determined by whole-body CT (16 mA) followed by PET acquisition of 18FTHA
Left ventricular function by Positron Emiting Positron (PET) ventriculography	2 months	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

Secondary Outcome Measures

Name	Time	Method
Cardiac and hepatic oxidative metabolism index	2 months	will be determined using 11C-acetate PET/CT followed by a 30 minutes dynamic PET acquisition.
metabolites appearance rate	6 months	will be determined by perfusion of stable isotope tracers
Insulin secretion rate	4 months	will be assessed using deconvolution of plasma C-peptide with standard Cpeptide kinetic parameters
β-cell function	4 months	will be assessed by calculation of the disposition index (DI) that is insulin secretion in response to the ambient insulin
Anthropometric parameters	2 months	will be measured at each postprandial metabolic study
energy metabolism (whole body production)	4 months	by indirect calorimetry
Insulin sensitivity	4 months	will be determined using the HOMA-IR (based on fasting insulin and glucose) levels
Cardiac DFA uptake	2 months	will be assessed using PET/CT method with oral administration of 18FTHA followed by a 30 min. dynamic PET acquisition
Cardiac and hepatic blood flow	2 months	will be determined using 11C-acetate PET/CT followed by a 30 minutes dynamic PET acquisition..
hormonal responses	4 months	analysed by colorimetric and Elisa tests

Trial Locations

Locations (1)

Centre de recherche du CHUS; 🇨🇦 Sherbrooke, Quebec, Canada