Goji Berries and Energy Expenditure
2017年1月31日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
18
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Limburg
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Maastricht、Limburg、オランダ、6229 ER
- Maastricht University Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
男
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Lycium Barbarum mixed meal
Subjects will receive a high-fat mixed meal containing Lycium Barbarum once.
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This mixed meal contains 25 grams of dried Lycium Barbarum (Goji berry, Wolfberry)
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アクティブコンパレータ：Control mixed meal
Subjects will receive a high-fat mixed meal without Lycium Barbarum as a control.
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This mixed meal does not contain Lycium Barbarum, but is matched for energy and macronutrient content
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline energy expenditure
時間枠：Measured as the incremental area under the curve (iAUC) from 0 minutes to 140 minutes after meal intake
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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)
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Measured as the incremental area under the curve (iAUC) from 0 minutes to 140 minutes after meal intake
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline energy expenditure
時間枠：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
|
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Postprandial lipid and glucose oxidation
時間枠：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
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Lipid and glucose oxidation will be calculated from indirect calorimetry data (VO2 and VCO2).
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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
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Metabolic flexibility
時間枠：At 60, 120, 180 and 240 minutes after meal intake
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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
時間枠：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
|
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Markers for glucose metabolism
時間枠：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.
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At baseline (T0) and at regular intervals up to 240 minutes after meal consumption
|
|
Inflammatory status
時間枠：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
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At baseline (T0) and at 60, 120, 180 and 240 minutes after meal consumption
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年4月1日
一次修了 (実際)
2016年12月1日
研究の完了 (実際)
2016年12月1日
試験登録日
最初に提出
2016年4月18日
QC基準を満たした最初の提出物
2016年5月18日
最初の投稿 (見積もり)
2016年5月23日
学習記録の更新
投稿された最後の更新 (見積もり)
2017年2月1日
QC基準を満たした最後の更新が送信されました
2017年1月31日
最終確認日
2016年4月1日
詳しくは
本研究に関する用語
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