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…
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Brief title
Condition
- Other condition
Synonym
Health condition
Metabolisme
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study will be postprandial energy expenditure
measured with the ventilated hood system.
Secondary outcome
Secondary study parameters are postprandial lipid and glucose oxidation,
metabolic flexibility (determined as changes in the respiratory quotient),
postprandial concentrations of triglycerides, apolipoprotein B48, free fatty
acids, insulin, C-peptide, glucose, IL-6, TNFa, postprandial leukocyte count
and differentiation and in vitro cytokine production.
Background summary
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 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.
Study objective
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.
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 burden and risks
Subjects will be screened for eligibility before the start of the study during
a screening visit of approximately 20 minutes. During the screening visit,
blood samples (5.5 ml) will be drawn using vena puncture for serum total
cholesterol, TAG, HDL-C and plasma glucose analysis and body weight and height
will be measured. The study consists of two test days separated by a washout
period of at least one week. Each test day lasts approximately 5,5 hours. On
these test days, a postprandial test will be performed. Subjects will visit the
university after an overnight fast of at least 12 hours. During the
postprandial test, subjects are not allowed to consume any foods or drinks
except for water. Nine blood samples will be taken during the test with a total
volume of 107 ml per test day using an intravenous cannula. Furthermore,
indirect calorimetry will be measured at baseline and between T = 0 min * T =
140 min, T = 160 min * T = 200 min and T = 220 * 260 min after meal intake.
Subjects will be asked to complete a food frequency questionnaire at home and
keep record of changes in health and alcohol use in a diary. Blood sampling
might cause bruising or hematoma. Indirect calorimetry might evoke
claustrophobic reactions, but there are no physical risks involved. Total time
investment for subjects is approximately 11 hours, excluding traveling time. L.
Barbarum is commercially available and we therefore do not foresee any risks
related to the consumption of this food product.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Male gender
- Aged between 18 and 65 years
- BMI between 25-30 kg/m2
- Non-smoking
- Normal triacylglycerol levels (<2.2 mmol/L)
- No hyperglycaemia or hypercholesterolemia (fasting glucose < 7.0 mmol/L and total cholesterol < 8.0 mmol/L)
- Signed informed consent
Exclusion criteria
- Use of anticoagulant medication
- Any medical condition that can interfere with the study judged by the principal investigator:
- Usage of any kind of medication or medically prescribed diet that can interfere with the results of the study, judged by the principal investigator
- Usage of antibiotics in the three weeks prior to the screening or during the study
- Usage of food supplements or plant stanol/sterol enriched products in the three weeks prior to the screening and during the study
- Indication of treatment according to the Standard for Cardiovascular risk management by the Dutch General Practitioners community
- 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
- Consumption > 14 glasses alcohol per week
- Reported intense sporting activities > 10 hours per week
- Abuse of drugs
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Na goedkeuring van de METC wordt het protocol in het ClinicalTrials.gov geregistreerd |
| CCMO | NL55654.068.15 |