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Completed

NCT Number: NCT01792089

Fructose-induced Intestinal de Novo Lipogenesis

8 healthy volunteers, 8 pre-bypass obese subjects, 8 subjects between 12-18 months post-bypass, and 8 subjects matched to the post-bypass patients will be studied in two sub-studies Sub-study 1) after ingestion of two or three different of the following test-meals: A)cream and whey protein B)cream, whey protein and fructose + 13C6 fructose C)test meal with cream, whey protein, fructose and glucose + 13C6 fructose Their intestinal de novo lipogenesis will be estimated by measuring 13C-palmitate on triglyceride-rich lipoprotein particles associated with apoB48 in blood Sub-study 2) after ingestion of two or three different of the following test-meals: A)cream labelled with 13C6 palmitic acid and whey protein B))cream labelled with 13C6 palmitic acid, whey protein, fructose and glucose

Their intestinal de novo lipogenesis will be estimated by measuring 13C-palmitate on triglyceride-rich lipoprotein particles associated with apoB48 in blood in sub-study 1

Their exogenous lipid absorption kinetics will be assessed by measuring 13C palmitate on triglyceride-rich lipoprotein particles associated with apoB48 in sub-study 2

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age 18-50 years
  • sex male or female
  • less than 2 kg body weight change over the past 3 months subjects

Exclusion criteria

  • antidiabetic and hypolipemic drugs
  • alcohol consumption >20g/day
  • severe eating disorders
  • severe psychological problems
  • vegetarian diet or other specific diet
  • consumption of illicit substances
  • pregnancy
  • weight gain or weight loss > 1 kg in the last 3 months

Treatment and study plan

fat+protein meal

Other

cream+ whey protein

Fat + protein + 13C fructose meal

Other

cream+ whey protein +13C fructose

Fat+protein+13C fructose+glucose meal

Other

Cream + whey protein + glucose:13C fructose mixture

13C Fat + whey protein

Other

cream labelled with 13C palmitate + whey protein

13C Fat + whey protein + glucose+ glucose meal

Other

cream labelled with 13C palmitate + whey protein + glucose:fructose mixture

Primary outcomes

  1. Intestinal de novo lipogenesis (sub-study 1)

    Time frame: 0-8-hour post-prandial

    Measurement of total TG and 13C palmitate in chylomicrons: The sf >20 fraction of post-prandial blood samples will be prepared, and non-chylomicrons, apoB100-containing lipoprotein will be removes by immuno-affinity chromatography using a specific anti-apoB100 antibody

  2. Postprandial exogenous, labelled palmitate concentration (sub-study 2)

    Time frame: 0-8-hour post-prandial

    Measurement of total TG and 13C palmitate in chylomicrons of sf >20 fraction of post-prandial blood samples will be prepared,

Secondary outcomes

  1. post-prandial triglyceride profile (sub-studies 1 and 2

    Time frame: 0-8 hour post-prandial

    Triglyceride will be measured in the chylomicron, VLDL, LDL and HDL fractions of post-prandial blood samples

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Registry information

Official study title

Measure of Intestinal Lipogenesis in Healthy Volunteers and Obese Subjects Before and After Gastroplasty: Modulation by Glucose and Fructose

Acronym: FIDNL

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2013
Registry last updated
Mar 25, 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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