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Goji Berries and Energy Expenditure

31. januar 2017 opdateret af: Maastricht University Medical Center

The Effect of a Single Dose of Lycium Barbarum on Postprandial Energy Expenditure in Healthy Overweight Men

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Holland
    • Limburg
      • Maastricht, Limburg, Holland, 6229 ER
        • Maastricht University Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lycium Barbarum mixed meal
Subjects will receive a high-fat mixed meal containing Lycium Barbarum once.
Kosttilskud: Lycium Barbarum mixed meal
This mixed meal contains 25 grams of dried Lycium Barbarum (Goji berry, Wolfberry)
Aktiv komparator: Control mixed meal
Subjects will receive a high-fat mixed meal without Lycium Barbarum as a control.
Kosttilskud: Control mixed meal
This mixed meal does not contain Lycium Barbarum, but is matched for energy and macronutrient content

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline energy expenditure
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline energy expenditure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
At baseline (T0) and at regular intervals up to 240 minutes after meal consumption
Markers for glucose metabolism
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Maastricht University Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2016

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

18. april 2016

Først indsendt, der opfyldte QC-kriterier

18. maj 2016

Først opslået (Skøn)

23. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2017

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • METC 15-3-060

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