Goji Berries and Energy Expenditure
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|ClinicalTrials.gov Identifier: NCT02779985|
Recruitment Status : Completed
First Posted : May 23, 2016
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Overweight||Dietary Supplement: Lycium Barbarum mixed meal Dietary Supplement: Control mixed meal||Not Applicable|
The primary objective of this study is to investigate the effect of a single dose of L. Barbarum on postprandial energy expenditure. Secondary objectives are to investigate the effect of a single dose of L. Barbarum on postprandial lipid and carbohydrate oxidation and metabolic flexibility, on postprandial lipid and glucose metabolism and on inflammatory markers.
This is a double blind, randomized, placebo-controlled intervention trial with two test days separated by a washout period of at least 1 week.
The study population will consist of 20 apparently healthy overweight (BMI between 25 and 30 kg/m2) men aged 18-65 years.
All subjects will receive a mixed meal including 25 grams of dried L. Barbarum as the intervention product and a matched mixed meal without L. Barbarum as the placebo product. The meals will be matched for energy content and macronutrient composition.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of a Single Dose of Lycium Barbarum on Postprandial Energy Expenditure in Healthy Overweight Men|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Lycium Barbarum mixed meal
Subjects will receive a high-fat mixed meal containing Lycium Barbarum once.
Dietary Supplement: Lycium Barbarum mixed meal
This mixed meal contains 25 grams of dried Lycium Barbarum (Goji berry, Wolfberry)
Active Comparator: Control mixed meal
Subjects will receive a high-fat mixed meal without Lycium Barbarum as a control.
Dietary Supplement: Control mixed meal
This mixed meal does not contain Lycium Barbarum, but is matched for energy and macronutrient content
- Change from baseline energy expenditure [ Time Frame: Measured as the incremental area under the curve (iAUC) from 0 minutes to 140 minutes after meal intake ]Energy expenditure will be measured using indirect calorimetry (ventilated hood system). This system measures oxygen consumption (VO2) and carbon dioxide production (VCO2) to calculate the energy expenditure (kJ/min)
- Change from baseline energy expenditure [ Time Frame: Measured as the incremental area under the curve (iAUC) from 160 minutes to 200 minutes and from 220 minutes to 260 minutes after meal intake ]Energy expenditure will be measured using indirect calorimetry (ventilated hood system). This system measures VO2 and VCO2 to calculate the energy expenditure (kJ/min).
- Postprandial lipid and glucose oxidation [ Time Frame: At baseline (T0, fasting) and between 0 minutes and 140 minutes, between 160 minutes and 200 minutes and between 220 minutes and 260 minutes after meal consumption ]Lipid and glucose oxidation will be calculated from indirect calorimetry data (VO2 and VCO2).
- Metabolic flexibility [ Time Frame: At 60, 120, 180 and 240 minutes after meal intake ]Metabolic flexibility will be derived from indirect calorimetry as the difference in respiratory quotient (RQ) between fasting and postprandial conditions.
- Markers for lipid metabolism [ Time Frame: At baseline (T0) and at regular intervals up to 240 minutes after meal consumption ]Several markers for lipid metabolism will be measured in blood samples.
- Markers for glucose metabolism [ Time Frame: At baseline (T0) and at regular intervals up to 240 minutes after meal consumption ]Several markers for glucose metabolism will be measured in blood samples.
- Inflammatory status [ Time Frame: At baseline (T0) and at 60, 120, 180 and 240 minutes after meal consumption ]Several markers for inflammatory status will be measured in blood samples and in vitro conditions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779985
|Maastricht University Medical Center|
|Maastricht, Limburg, Netherlands, 6229 ER|
|Principal Investigator:||Ronald Mensink, Professor||Maastricht University Medical Center|
|Principal Investigator:||Jogchum Plat, Professor||Maastricht University Medical Center|