Effect of a Carbohydrate-rich Diet in Healthy Subjects

NCT ID: NCT04088344

Last Updated: 2019-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-10

Study Completion Date

2019-07-02

Brief Summary

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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.

Detailed Description

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Conditions

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Lipid Metabolism Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Study Groups

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Isocaloric diet (7 days)

Protocole A

Group Type PLACEBO_COMPARATOR

isocaloric diet

Intervention Type DIETARY_SUPPLEMENT

a 7-day isocaloric diet

Liquid meal

Intervention Type OTHER

PET imaging

Intervention Type RADIATION

perfusions of stable tracers

Intervention Type OTHER

Indirect calorimetry

Intervention Type DEVICE

Hypercaloric diet enriched with carbohydrate food (7 days)

Protocole B

Group Type EXPERIMENTAL

Hypercaloric diet

Intervention Type DIETARY_SUPPLEMENT

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

Liquid meal

Intervention Type OTHER

PET imaging

Intervention Type RADIATION

perfusions of stable tracers

Intervention Type OTHER

Indirect calorimetry

Intervention Type DEVICE

Interventions

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isocaloric diet

a 7-day isocaloric diet

Intervention Type DIETARY_SUPPLEMENT

Hypercaloric diet

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

Intervention Type DIETARY_SUPPLEMENT

Liquid meal

Intervention Type OTHER

PET imaging

Intervention Type RADIATION

perfusions of stable tracers

Intervention Type OTHER

Indirect calorimetry

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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André Carpentier

tenured professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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André Carpentier

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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Centre de recherche du CHUS

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 33870714 (View on PubMed)

Other Identifiers

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2013-530, 12-201

Identifier Type: -

Identifier Source: org_study_id

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