- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02779985
Goji Berries and Energy Expenditure
The Effect of a Single Dose of Lycium Barbarum on Postprandial Energy Expenditure in Healthy Overweight Men
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Limburg
-
Maastricht, Limburg, Niederlande, 6229 ER
- Maastricht University Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
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)
|
Aktiver Komparator: 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change from baseline energy expenditure
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change from baseline energy expenditure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
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At 60, 120, 180 and 240 minutes after meal intake
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Markers for lipid metabolism
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
At baseline (T0) and at 60, 120, 180 and 240 minutes after meal consumption
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- METC 15-3-060
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