- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02779985
Goji Berries and Energy Expenditure
The Effect of a Single Dose of Lycium Barbarum on Postprandial Energy Expenditure in Healthy Overweight Men
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229 ER
- Maastricht University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male gender
- BMI between 25 and 30 kg/m2
- Non-smoking
- Normal fasting triacylglycerol levels (<2.2 mmol/L)
- No hyperglycaemia or hypercholesterolemia (fasting glucose < 7.0 mmol/L and total cholesterol < 8.0 mmol/L)
- Willing to comply to the study protocol during the study
- Agreeing to be informed about medically relevant personal test-results
Exclusion Criteria:
- Use of anticoagulant medication
- Unstable body weight (weight gain or loss >3 kg in the past 3 months)
- Indications of treatment according to the Standard for Cardiovascular Risk Management from the Dutch General Practitioners community
- Any medical condition that might interfere with study measurements, judged by the principal investigator, including cardiovascular disease or events (e.g. acute myocardial infarction or cerebra-vascular accident), diabetes or hypercholesterolemia
- Use of any kind of medication or medically prescribed diet, which can interfere with the study (judged by the principal investigator). The use of paracetamol is allowed
- Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to the start of the study
- Use of food supplements or plant-sterol/stanol-enriched foods or supplements in the three weeks prior to the screening and/or during the study
- Not willing to abstain from L. Barbarum consumption thee weeks before the start and during the trial
- Severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease and rheumatoid arthritis
- Consumption of > 14 alcohol consumptions a week
- Reported intense sporting activities > 10 hours a week
- Abuse of drugs
- Participation in any other biomedical trial one month prior to the screening visit
- Having donated > 150 ml blood within 1 month prior to the screening visit, planning to donate blood during the study or within one month after finishing the study
- Impossible or difficult to puncture as evidenced during the screening visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lycium Barbarum mixed meal
Subjects will receive a high-fat mixed meal containing Lycium Barbarum once.
|
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.
|
This mixed meal does not contain Lycium Barbarum, but is matched for energy and macronutrient content
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Measured as the incremental area under the curve (iAUC) from 0 minutes to 140 minutes after meal intake
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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
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).
|
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
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.
|
At 60, 120, 180 and 240 minutes after meal intake
|
Markers for lipid metabolism
Time Frame: At baseline (T0) and at regular intervals up to 240 minutes after meal consumption
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Several markers for lipid metabolism will be measured in blood samples.
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At baseline (T0) and at regular intervals up to 240 minutes after meal consumption
|
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.
|
At baseline (T0) and at regular intervals up to 240 minutes after meal consumption
|
Inflammatory status
Time Frame: At baseline (T0) and at 60, 120, 180 and 240 minutes after meal consumption
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Several markers for inflammatory status will be measured in blood samples and in vitro conditions
|
At baseline (T0) and at 60, 120, 180 and 240 minutes after meal consumption
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC 15-3-060
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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