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

Primary Purpose

Lipid Metabolism Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
isocaloric diet
Hypercaloric diet
Liquid meal
PET imaging
perfusions of stable tracers
Indirect calorimetry
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lipid Metabolism Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre de recherche du CHUS

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Isocaloric diet (7 days)

Hypercaloric diet enriched with carbohydrate food (7 days)

Arm Description

Protocole A

Protocole B

Outcomes

Primary Outcome Measures

whole-body organ-specific Dietary Fatty Acid (DFA) partitioning
will be determined by whole-body CT (16 mA) followed by PET acquisition of 18FTHA
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

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2019
Last Updated
September 11, 2019
Sponsor
Université de Sherbrooke
Collaborators
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04088344
Brief Title
Effect of a Carbohydrate-rich Diet in Healthy Subjects
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 10, 2013 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
July 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isocaloric diet (7 days)
Arm Type
Placebo Comparator
Arm Description
Protocole A
Arm Title
Hypercaloric diet enriched with carbohydrate food (7 days)
Arm Type
Experimental
Arm Description
Protocole B
Intervention Type
Dietary Supplement
Intervention Name(s)
isocaloric diet
Intervention Description
a 7-day isocaloric diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Hypercaloric diet
Intervention Description
A 7-day hypercaloric diet supplemented with carbohydrate-rich food (+ 50% of the subject's energy needs).
Intervention Type
Other
Intervention Name(s)
Liquid meal
Intervention Type
Radiation
Intervention Name(s)
PET imaging
Intervention Type
Other
Intervention Name(s)
perfusions of stable tracers
Intervention Type
Device
Intervention Name(s)
Indirect calorimetry
Primary Outcome Measure Information:
Title
whole-body organ-specific Dietary Fatty Acid (DFA) partitioning
Description
will be determined by whole-body CT (16 mA) followed by PET acquisition of 18FTHA
Time Frame
2 months
Title
Left ventricular function by Positron Emiting Positron (PET) ventriculography
Description
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
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Cardiac DFA uptake
Description
will be assessed using PET/CT method with oral administration of 18FTHA followed by a 30 min. dynamic PET acquisition
Time Frame
2 months
Title
Cardiac and hepatic oxidative metabolism index
Description
will be determined using 11C-acetate PET/CT followed by a 30 minutes dynamic PET acquisition.
Time Frame
2 months
Title
Cardiac and hepatic blood flow
Description
will be determined using 11C-acetate PET/CT followed by a 30 minutes dynamic PET acquisition..
Time Frame
2 months
Title
metabolites appearance rate
Description
will be determined by perfusion of stable isotope tracers
Time Frame
6 months
Title
energy metabolism (whole body production)
Description
by indirect calorimetry
Time Frame
4 months
Title
hormonal responses
Description
analysed by colorimetric and Elisa tests
Time Frame
4 months
Title
Insulin sensitivity
Description
will be determined using the HOMA-IR (based on fasting insulin and glucose) levels
Time Frame
4 months
Title
Insulin secretion rate
Description
will be assessed using deconvolution of plasma C-peptide with standard Cpeptide kinetic parameters
Time Frame
4 months
Title
β-cell function
Description
will be assessed by calculation of the disposition index (DI) that is insulin secretion in response to the ambient insulin
Time Frame
4 months
Title
Anthropometric parameters
Description
will be measured at each postprandial metabolic study
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Carpentier
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche du CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33870714
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.
Results Reference
derived

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Effect of a Carbohydrate-rich Diet in Healthy Subjects

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