Healthy Effects of an Innovative Probiotic Pasta (SFLABPASTA)
調査の概要
詳細な説明
Epidemiological evidences indicate that consumption of whole grains products is associated to a decreased risk for common chronic diseases, as cardiovascular diseases, diabetes, obesity, hypertension and metabolic syndrome. In the present study a whole grain pasta was supplemented with prebiotics and probiotics 'ad hoc' formulated. In detail, pasta was industrially developed after the identification of particular cultivars of wheat and barley, rich in carotenoids, β-glucans (2.6 g/100g pasta), not soluble fibers and antioxidants. Further, pasta was supplemented with spores of Bacillus coagulans, a putative probiotic microorganism, belonging to Lactobacillus family. It is well demonstrated the ability of this microorganism to survive to technological processes and to upper gastro-intesinal tract, in order to exert beneficial effects in the lower gut, as anti-microbial activity, increasing immunological defences as well as improvements in intestinal regularity. Conversely, the control pasta was made from the same cultivar of grain and by the same technological process, but without any supplementation.
In this parallel randomized controlled one arm trial, 40 healthy volunteers were randomly allocated for the consumption of the two kind of pasta once a day, for 12 weeks. At the beginning of the study and every 4 weeks, subjects were asked to provide blood, urine and feces for the evaluation of:
- blood inflammation markers;
- blood lipid and carbohydrate profile;
- blood and urine markers of cardiovascular risk;
- feces profile of microbiota and detection of markers for the healthiness of the gut.
In addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.
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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Parma、イタリア、43124
- University of Parma
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PR
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Parma、PR、イタリア、43124
- University of Parma - Department of Food Sciences
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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:
- Overweight / Obesity
- Lower consumers of fruit and vegetables
Exclusion Criteria:
- Antibiotic treatment within 3 months prior the pasta feeding
- Chronic diseases
- Surgeries
- Consumer of whole grain products
- Dieting
- Pregnant or lactating
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：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター：Control pasta
Volunteers were fed with control pasta, without B-glucans and spores of B. coagulans once a day for 12 weeks.
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Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.
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実験的：Probiotic Whole Grain Pasta
Volunteers were fed with probiotic fortified pasta, including B-glucans and spores of B. coagulans once a day for 12 weeks.
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Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.
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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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Variation of plasma lipids
時間枠：12 weeks
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Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol; Measure of plasma concentrations (µg/mL) of Non Esterified Fatty Acids (NEFA), Esterified Fatty Acids (EFA) and Short Chain Fatty Acids (SCFA). Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered. |
12 weeks
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Variation of fecal microbiota composition
時間枠：12 weeks
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By FISH (colony-forming unit, CFU/g). Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered. |
12 weeks
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Variation of antioxidant activity on fecal waters
時間枠：12 weeks
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Measure of fecal waters FRAP (µmol/L) and TEAC (µmol/L) concentrations. Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered. |
12 weeks
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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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Variation of body weight
時間枠：12 weeks
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Measure of body weight (kg).
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12 weeks
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Variation of serum inflammatory marker concentration
時間枠：12 weeks
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Measure of serum IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IFN-γ,TNF-α, PAI-1, Ghrelin, Leptin, Visfatin, Resistin concentrations (pg/mL). Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered. |
12 weeks
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Variation of blood pressure
時間枠：12 weeks
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Measure of blood pressure (mmHg). Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered. |
12 weeks
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Variation of body circumferences
時間枠：12 weeks
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Measure of waist and hip circumferences (mm). Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered. |
12 weeks
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Variation of urine antioxidant marker
時間枠：12 weeks
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Measurement of betaine in urine (mmol/L). Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered. |
12 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Nicoletta Pellegrini, Professor、University of Parma
出版物と役立つリンク
一般刊行物
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研究記録日
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研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
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