Effect of a Carbohydrate-rich Diet in Healthy Subjects

NCT04088344 | Completed

• 1 other identifier: 2013-530, 12-201
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipid Metabolism Disorder

Outcome Measures

Primary Outcomes (2)

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

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

  2 months

• 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

  2 months

Secondary Outcomes (10)

• Cardiac DFA uptake

  2 months

• Cardiac and hepatic oxidative metabolism index

  2 months

• Cardiac and hepatic blood flow

  2 months

• metabolites appearance rate

  6 months

• energy metabolism (whole body production)

  4 months

Study Arms (2)

Isocaloric diet (7 days)

PLACEBO COMPARATOR

Protocole A

Dietary Supplement: isocaloric diet; Other: Liquid meal; Radiation: PET imaging; Other: perfusions of stable tracers; Device: Indirect calorimetry

Hypercaloric diet enriched with carbohydrate food (7 days)

EXPERIMENTAL

Protocole B

Dietary Supplement: Hypercaloric diet; Other: Liquid meal; Radiation: PET imaging; Other: perfusions of stable tracers; Device: Indirect calorimetry

Interventions

isocaloric diet DIETARY_SUPPLEMENT

a 7-day isocaloric diet

Isocaloric diet (7 days)

Hypercaloric diet DIETARY_SUPPLEMENT

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

Hypercaloric diet enriched with carbohydrate food (7 days)

Liquid meal OTHER

Hypercaloric diet enriched with carbohydrate food (7 days); Isocaloric diet (7 days)

PET imaging RADIATION

Hypercaloric diet enriched with carbohydrate food (7 days); Isocaloric diet (7 days)

perfusions of stable tracers OTHER

Hypercaloric diet enriched with carbohydrate food (7 days); Isocaloric diet (7 days)

Indirect calorimetry DEVICE

Hypercaloric diet enriched with carbohydrate food (7 days); Isocaloric diet (7 days)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Hospices Civils de Lyon: collaborator

Study Sites (1)

Centre de recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• 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.

  PMID: 33870714 DERIVED

MeSH Terms

Conditions

Lipid Metabolism Disorders

Interventions

Magnetic Resonance Spectroscopy; Calorimetry, Indirect

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Calorimetry

Study Officials

• André Carpentier

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: tenured professor

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 12, 2019
• Study Start: April 10, 2013
• Primary Completion: March 20, 2019
• Study Completion: July 2, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

CA (1)