Goji Berries and Energy Expenditure
کلید واژه ها
خلاصه
شرح
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.
تاریخ
| آخرین تأیید شده: | 03/31/2016 |
| اولین ارسال: | 04/17/2016 |
| ثبت نام تخمینی ارسال شد: | 05/17/2016 |
| اولین ارسال: | 05/22/2016 |
| آخرین بروزرسانی ارسال شده: | 01/30/2017 |
| آخرین به روزرسانی ارسال شده: | 01/31/2017 |
| تاریخ شروع مطالعه واقعی: | 03/31/2016 |
| تاریخ تخمین اولیه اولیه: | 11/30/2016 |
| تاریخ برآورد مطالعه: | 11/30/2016 |
شرایط یا بیماری
مداخله / درمان
Dietary Supplement: Lycium Barbarum mixed meal
Dietary Supplement: Control mixed meal
فاز
گروههای بازو
| بازو | مداخله / درمان |
|---|---|
| Experimental: Lycium Barbarum mixed meal Subjects will receive a high-fat mixed meal containing Lycium Barbarum once. | Dietary Supplement: Lycium Barbarum mixed meal 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. | Dietary Supplement: Control mixed meal This mixed meal does not contain Lycium Barbarum, but is matched for energy and macronutrient content |
معیارهای صلاحیت
| سنین واجد شرایط تحصیل | 18 Years به 18 Years |
| جنسیت واجد شرایط مطالعه | Male |
| داوطلبان سالم را می پذیرد | آره |
| شاخص | 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 |
نتیجه
اقدامات اولیه
1. Change from baseline energy expenditure [Measured as the incremental area under the curve (iAUC) from 0 minutes to 140 minutes after meal intake]
اقدامات ثانویه
1. Change from baseline energy expenditure [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]
2. Postprandial lipid and glucose oxidation [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]
3. Metabolic flexibility [At 60, 120, 180 and 240 minutes after meal intake]
4. Markers for lipid metabolism [At baseline (T0) and at regular intervals up to 240 minutes after meal consumption]
5. Markers for glucose metabolism [At baseline (T0) and at regular intervals up to 240 minutes after meal consumption]
6. Inflammatory status [At baseline (T0) and at 60, 120, 180 and 240 minutes after meal consumption]
