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Completed

NCT Number: NCT00465036

Effect of Flaxseed on Lipid Uptake and Appetite

Randomized trial to test the effect of flaxseed fractions on appetite regulation and intestinal lipid absorption.

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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

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Human Nutrition

Frederiksberg C, 1958, Denmark

About this study

Randomized multiple crossover trial in 18 healthy males aged 18 to 40 years each are required to complete a total of five iso-caloric meal tests lasting approximately 8½ hours. Test meals will be given as breakfast meals, in which different fractions of flaxseeds are incorporated into baked products. Appetite will be registered using visual analogue scales during 7 hours after the test meal and a total of 10 blood samples will be drawn to evaluate TAG in chylomicrons, plasma LDL, HDL and total cholesterol, plasma TAG, insulin, glucose and appetite hormone levels. At the end of the test day an ad libitum meal will be served and food intake registered.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males aged 18-40 years
  • Normal weight or moderately overweigh (BMI 25-30 kg/m2)

Exclusion criteria

  • Blood drawing/donation less than six months prior to start of the study
  • Hemoglobin concentration <8mmol/L
  • Chronic diseases (i.e. diabetes, CVD), hypertension, hyperlipidemia
  • Consumption of dietary supplements including vitamin tablets
  • Smoking
  • Excess physical activity (>10h of intense physical activity per week)
  • Medicine use (not including occasional consumption of pain killers)

Treatment and study plan

Whole flaxseeds, flaxseed mucilage, glucomannan

Dietary Supplement

Primary outcomes

  1. TAG in chylomicrons

  2. serum TAG

  3. HDL, LDL and total cholesterol

  4. appetite scores

  5. ad libium food intake

  6. appetite hormone levels

Secondary outcomes

  1. free fatty acid profile

  2. plasma glucose

  3. plasma insulin

  4. meal macronutrient composition

  5. meal energy content

  6. meal pleasantness

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

Effect of Whole Flaxseeds and Flaxseed Mucilage on Lipid Absorption, Glucose and Insulin Metabolism and Appetite Regulation

Important dates

Study start
2006
Study completion
2007
First posted
Apr 24, 2007
Registry last updated
Mar 26, 2009

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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