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Completed

NCT Number: NCT04088344

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.

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Key information

Conditions

Lipid Metabolism Disorder Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isocaloric diet

Dietary Supplement

a 7-day isocaloric diet

Hypercaloric diet

Dietary Supplement

A 7-day hypercaloric diet supplemented with carbohydrate-rich food (+ 50% of the subject's energy needs).

liquid meal

Other

PET Imaging

Radiation

perfusions of stable tracers

Other

Indirect calorimetry

Device

Primary outcomes

  1. whole-body organ-specific Dietary Fatty Acid (DFA) partitioning

    Time frame: 2 months

    will be determined by whole-body CT (16 mA) followed by PET acquisition of 18FTHA

  2. Left ventricular function by Positron Emiting Positron (PET) ventriculography

    Time frame: 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 outcomes

  1. Cardiac DFA uptake

    Time frame: 2 months

    will be assessed using PET/CT method with oral administration of 18FTHA followed by a 30 min. dynamic PET acquisition

  2. Cardiac and hepatic oxidative metabolism index

    Time frame: 2 months

    will be determined using 11C-acetate PET/CT followed by a 30 minutes dynamic PET acquisition.

  3. Cardiac and hepatic blood flow

    Time frame: 2 months

    will be determined using 11C-acetate PET/CT followed by a 30 minutes dynamic PET acquisition..

  4. metabolites appearance rate

    Time frame: 6 months

    will be determined by perfusion of stable isotope tracers

  5. energy metabolism (whole body production)

    Time frame: 4 months

    by indirect calorimetry

  6. hormonal responses

    Time frame: 4 months

    analysed by colorimetric and Elisa tests

  7. Insulin sensitivity

    Time frame: 4 months

    will be determined using the HOMA-IR (based on fasting insulin and glucose) levels

  8. Insulin secretion rate

    Time frame: 4 months

    will be assessed using deconvolution of plasma C-peptide with standard Cpeptide kinetic parameters

  9. β-cell function

    Time frame: 4 months

    will be assessed by calculation of the disposition index (DI) that is insulin secretion in response to the ambient insulin

  10. Anthropometric parameters

    Time frame: 2 months

    will be measured at each postprandial metabolic study

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study 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

Acronym: AGL9

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2019
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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