An interventional study of Lycium Barbarum mixed meal and Control mixed meal in Overweight, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-01.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Prevention
Effects of foods or food substances on energy expenditure are of particular interest, because of the increasing prevalence of obesity and its consequent metabolic diseases like type II diabetes and fatty liver disease, all risk factors for the development of cardiovascular diseases (CVDs). Recently, the Goji berry (Lycium Barbarum, wolfberry) was introduced into the Western diet. L. Barbarum originates from Asia, where it is used to improve the health of several organs. Although L. Barbarum is promoted as a super food with many beneficial effects, consistent scientific evidence for these effects is lacking. In one study, it was found that short-term intake of L. Barbarum polysaccharides - equal to 150 g of fresh berries - increased postprandial oxygen consumption. This indicates that L. Barbarum might exert beneficial effects on energy expenditure. Furthermore, long-term intervention trials have shown beneficial effects of L. Barbarum on lipid and glucose metabolism in mice and type II diabetic patients and on inflammatory status in healthy elderly. Altogether, L. Barbarum has the potential to be used as a functional food to increase metabolic health, but detailed information on the postprandial effects of L. Barbarum is missing. We therefore propose this double-blinded, randomized, placebo controlled intervention trial to investigate the effect of a single dose of L. Barbarum on postprandial energy expenditure substrate oxidation, metabolic flexibility, lipid and glucose metabolism and inflammatory markers.
Objectives:
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.
Study design:
This is a double blind, randomized, placebo-controlled intervention trial with two test days separated by a washout period of at least 1 week.
Study population:
The study population will consist of 20 apparently healthy overweight (BMI between 25 and 30 kg/m2) men aged 18-65 years.
Intervention:
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.
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's enrollment of 18 is below the median of 73 across 3,263 interventional studies indexed under Overweight.
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Exclusion Criteria:
Subjects will receive a high-fat mixed meal containing Lycium Barbarum once.
Dietary Supplement: Lycium Barbarum mixed meal
Subjects will receive a high-fat mixed meal without Lycium Barbarum as a control.
Dietary Supplement: Control mixed meal
This mixed meal contains 25 grams of dried Lycium Barbarum (Goji berry, Wolfberry)
This mixed meal does not contain Lycium Barbarum, but is matched for energy and macronutrient content
Change from baseline energy expenditure
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)
Time frame: Measured as the incremental area under the curve (iAUC) from 0 minutes to 140 minutes after meal intake
Change from baseline energy expenditure
Energy expenditure will be measured using indirect calorimetry (ventilated hood system). This system measures VO2 and VCO2 to calculate the energy expenditure (kJ/min).
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
Postprandial lipid and glucose oxidation
Lipid and glucose oxidation will be calculated from indirect calorimetry data (VO2 and VCO2).
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
Metabolic flexibility
Metabolic flexibility will be derived from indirect calorimetry as the difference in respiratory quotient (RQ) between fasting and postprandial conditions.
Time frame: At 60, 120, 180 and 240 minutes after meal intake
Markers for lipid metabolism
Several markers for lipid metabolism will be measured in blood samples.
Time frame: At baseline (T0) and at regular intervals up to 240 minutes after meal consumption
Markers for glucose metabolism
Several markers for glucose metabolism will be measured in blood samples.
Time frame: At baseline (T0) and at regular intervals up to 240 minutes after meal consumption
Inflammatory status
Several markers for inflammatory status will be measured in blood samples and in vitro conditions
Time frame: At baseline (T0) and at 60, 120, 180 and 240 minutes after meal consumption
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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