AGL9: Effect of a Carbohydrate-rich Diet in Healthy Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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 |
Dietary Supplement: 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 oxidative metabolism index [2 months]
will be determined using 11C-acetate PET/CT followed by a 30 minutes 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..
- metabolites appearance rate [6 months]
will be determined by perfusion of stable isotope tracers
- energy metabolism (whole body production) [4 months]
by indirect calorimetry
- hormonal responses [4 months]
analysed by colorimetric and Elisa tests
- Insulin sensitivity [4 months]
will be determined using the HOMA-IR (based on fasting insulin and glucose) levels
- 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
Eligibility Criteria
Criteria
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)
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presence of liver or renal disease, uncontrolled thyroid disorder, previous pancreatitis, bleeding disorder, or other major illness
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre de recherche du CHUS | Sherbrooke | Quebec | Canada | J1H 5N4 |
Sponsors and Collaborators
- Université de Sherbrooke
- Hospices Civils de Lyon
Investigators
- Principal Investigator: André Carpentier, Université de Sherbrooke
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2013-530, 12-201