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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01792089
Other study ID # 193/11
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2013
Est. completion date December 2016

Study information

Verified date March 2019
Source University of Lausanne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
fat+protein meal
cream+ whey protein
Fat + protein + 13C fructose meal
cream+ whey protein +13C fructose
Fat+protein+13C fructose+glucose meal
Cream + whey protein + glucose:13C fructose mixture
13C Fat + whey protein
cream labelled with 13C palmitate + whey protein
13C Fat + whey protein + glucose+ glucose meal
cream labelled with 13C palmitate + whey protein + glucose:fructose mixture

Locations

Country Name City State
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne VD

Sponsors (1)

Lead Sponsor Collaborator
University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intestinal de novo lipogenesis (sub-study 1) 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 0-8-hour post-prandial
Primary Postprandial exogenous, labelled palmitate concentration (sub-study 2) Measurement of total TG and 13C palmitate in chylomicrons of sf >20 fraction of post-prandial blood samples will be prepared, 0-8-hour post-prandial
Secondary post-prandial triglyceride profile (sub-studies 1 and 2 Triglyceride will be measured in the chylomicron, VLDL, LDL and HDL fractions of post-prandial blood samples 0-8 hour post-prandial
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