Clinical trial NCT04088344: Effect of a Carbohydrate-rich Diet in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Metabolism Disorder
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2019-09-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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)
* 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

Primary outcomes:
measure: whole-body organ-specific Dietary Fatty Acid (DFA) partitioning
timeFrame: 2 months
measure: Left ventricular function by Positron Emiting Positron (PET) ventriculography
timeFrame: 2 months
Secondary outcomes:
measure: Cardiac DFA uptake
timeFrame: 2 months
measure: Cardiac and hepatic oxidative metabolism index
timeFrame: 2 months
measure: Cardiac and hepatic blood flow
timeFrame: 2 months
measure: metabolites appearance rate
timeFrame: 6 months
measure: energy metabolism (whole body production)
timeFrame: 4 months
measure: hormonal responses
timeFrame: 4 months
measure: Insulin sensitivity
timeFrame: 4 months
measure: Insulin secretion rate
timeFrame: 4 months
measure: β-cell function
timeFrame: 4 months
measure: Anthropometric parameters
timeFrame: 2 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche du CHUS
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: André Carpentier
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.