Comparison Between Olive Oil and Palm Oil-enricHed chOCOlate Spreads (CHOCO) in Healthy Subjects (CHOCO)
Comparison Between Olive Oil and Palm Oil-enricHed chOCOlate Spreads (CHOCO) in Healthy Subjects: a Randomized, Double-blind, Cross-over Study
調査の概要
状態
条件
詳細な説明
Exceeding intake of foods high in palmitic acid, abundant in Palm Oil, has been associated with lipotoxicity, a condition featured by high toxic lipids in the body such as ceramides, which ultimately can lead to insulin resistance and therefore to diabetes and increased cardiometabolic risk through the promotion of atheroma plaque formation.
On the other hand, foods high in oleic acid, rich in extra virgin olive oil EVOO and typical of the Mediterranean diet, has been related to reduced insulin resistance and inflammatory state, with proved protective effects against metabolic diseases such as diabetes, hypercholesterolemia and cardiovascular disease.
Therefore, this clinical trial aims to assess potential metabolic differences in relation to daily consumption of EVOO-enriched chocolate spread in comparison with a Palm oil-enriched chocolate spread.
The investigators, therefore, aimed to evaluate the impact of fourteen days consuming the two different oils added to the same chocolate spread in terms of the composition of plasma ceramides as the primary outcome; and as secondary outcomes, changes in glucose metabolism markers (Glucose, Insulin, HOMA-IR), in LDL, total cholesterol, Triglycerides, HDL levels, in inflammation Markers (CRP, IL-6, TNF-a) and in the appetite-regulating hormones (Leptin, Adiponectin, GLP-1, Ghrelin, PYY and Oxyntomodulin) and in the visual analogue scale (VAS) analysis.
Both chocolate spreads have an identical composition with the exception of fat content (EVOO vs. Palm Oil).
Once eligibility will be assessed through screening and medical anamnesis, twenty healthy subjects will be enrolled and randomized based on a double-blind, controlled, crossover design.
They will undergo a 1-week "run-in diet" phase before the randomization (V1) and the inception of a 14-day interventional diet phase 1. A compliance visit (V2) will be performed on day-7 to ensure that daily compliance is available from each participant (i.e., that the chocolate spread provided is eaten daily). On day 14, the participants will undergo a meal Challenge (V3), consuming the chocolate spread jar (challenge meal) and, serial blood withdrawals will be performed at times 0 ', 30', 60 ', 90', 120 'and 180 ' and, at the same time points, subjects will be required to complete a Visual Analogue Scale (VAS) for monitoring hunger and satiety. Subsequently, the subjects will undergo another week of run-in diet, identical to the previous run-in diet, to be then allocated to another fourteen days of the opposite treatment to the previous one, with the same described methods. Also, in all the visits physical examination with the collection of anthropometric data and body composition analysis will be performed.
Study subjects will be provided structured meals, according to isocaloric diets designed by nutritionists based on subjects' energy requirements. Meals will be prepared by specific canteens and consumed on-site or collected daily in individual meal boxes. Patients will be asked to fill daily food diaries, in order to ensure all of the daily food is ingested (including the chocolate spread), as well as to assess any leftovers.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Lazio
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Rome、Lazio、イタリア、00128
- Campus Bio-Medico University of Rome
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Healthy volunteers of both genders.
- Aged > 18 years.
- Body mass index ranging from 18 to 29.99 kg/m2.
- Subjects able to provide written informed consent.
Exclusion Criteria:
- Diagnosis of diabetes. defined as per the Italian Society of Diabetology guidelines. fasting glucose twice greater than 126 mg / dL and/or random glucose greater than 200 mg / dL.
- Subjects being treated with oral and/or injectable hypoglycemic and/or insulin-sensitizing agents
- Subjects undergoing therapy with synthetic cholesterol-lowering agents (statins and/or fibrates) and/or cholesterol-lowering nutraceuticals (berberine and/or monacolin k)
- Individuals with triglycerides greater than 200 mg/dL
- Subjects with LDL greater than 159 mg/dL
- Moderate or major renal impairment (and GFR <60 mL/min)
- Hypertensive subjects and/or subjects being treated with antihypertensives
- Subjects receiving omega 3 supplements.
- Pregnancy and/or breastfeeding.
- Coronary cardiovascular disease.
- Stroke and heart failure.
- Celiac disease.
- Malabsorption.
- Irritable bowel syndrome.
- Chronic inflammatory bowel disease.
- Present alcoholism or drug abuse or use of medicines whose dose may change during the study or when there is an intention to start a new therapy.
- Individuals with an allergy to hazelnuts or any of the ingredients present in the chocolates under study.
- Neurological or psychiatric pathologies
- Subjects who cannot participate in the study for any reason
- Infectious diseases such as HIV, hepatitis or chronic infections
- Any uncontrolled endocrine pathology such as Cushing's. Acromegaly. etc.
- Any existing cancer and/or lymphoma
- Eating disorders such as anorexia and bulimia
- Previous bariatric surgery or gastrectomy
- Individuals with pacemakers
- Not consuming the chocolate spread for more than three days
研究計画
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：処理
- 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：4倍
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：Extra Virgin Olive Oil Group
Subjects will consume 100 grams of Extra Virgin Olive Oil-enriched chocolate spread for 14 days.
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the intervention consists in the administration of 100g Extra Virgin Olive Oil-enriched chocolate spread each day for 14 days.
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アクティブコンパレータ：Palm oil Group
Subjects will consume 100 grams of palm oil enriched chocolate spread for 14 days.
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the intervention consists in the administration of 100g Palm Oil-enriched chocolate spread each day for 14 days.
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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 |
|---|---|---|
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Plasma Ceramides
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Fasting Ceramides expressed in nmol
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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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 |
|---|---|---|
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Plasma HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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HOMA-IR calculated as ((fasting insulin (mU/mL) x fasting glucose (mg/dL))/405)
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Insulin
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Fasting Plasma Insulin reported in mU/mL
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Glucose
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Fasting Plasma glucose reported in mg/dL
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Low Density Lipoprotein (LDL)
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Fasting LDL reported in mg/dL
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Triglycerides
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Fasting Triglycerides reported in mg/dL
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Total Cholesterol
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Fasting Total Cholesterol reported in mg/dL
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma High Density Lipoprotein (HDL)
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Fasting Plasma HDL
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma C-reactive protein (CRP)
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Fasting CRP reported in mg/dL
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Interleukin-6
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Fasting interleukin-6 reported in pg/mL
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Tumor Necrosis Factor-alpha (TNF-alpha)
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Fasting TNF-alpha reported in pg/mL
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Glucagon Like Peptide-1 (GLP-1)
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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GLP-1 Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL*min.
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Oxyntomodulin
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Oxyntomodulin Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL*min.
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Ghrelin
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Ghrelin Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL*min.
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Peptide YY (PYY)
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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PYY Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL*min.
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Leptin
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Leptin Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL*min.
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Plasma Adiponectin
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Adiponectin Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in pg/mL*min.
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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Visual Analogue Scale (VAS)
時間枠：At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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VAS Area Under the Curve calculated below the following time points 0', +30', +60', +90', +120', +180' (minutes following chocolate spread consumption) reported in mm*min.
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At the end of the dietary interventional phase (each dietary interventional phase is 14 days)
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協力者と研究者
捜査官
- 主任研究者：Professor Silvia Manfrini, MD、Campus Bio-Medico University of Rome
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Extra Virgin Olive Oil-enriched chocolate spreadの臨床試験
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Universidad de GranadaUniversity of Jaén; NOTALIV cosmética natural完了イレオストミー - ストーマ | ストーマ周囲皮膚の合併症 | コロストミー ストーマスペイン