Randomized, Placebo-controlled, Clinical Study to Investigate Anti-metabolic Syndrome Effects of Functional Foods in Humans

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  • 機能性農産物を使用した弁当のメタボリックシンドロームへの影響を検証するヒト介入ランダム化プラセボ対照比較試験
  • キノウセイ ノウサンブツ オ シヨウ シタ ベントウ ノ メタボリックシンドローム エ ノ エイキョウ オ ケンショウ スル ヒト カイニュウ ランダムカ プラセボ タイショウ ヒカク シケン

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Abstract

<p>The development of food that prevents metabolic syndrome (MetS) by decreasing abdominal visceral fat (AVF) is highly anticipated, and testing of the efficacy of such foods in combination with other agricultural products is necessary. We investigated the lowering effects of functional boxed lunches on AVF. We performed a randomized placebo-controlled trial for healthy adults with BMI between 25 and 30, and with over 100cm2 AVF area (AVFA). Test foods were ‘side dishes’ prepared using functional agricultural products, namely ‘Benifuuki’ green tea, and ‘50% barley rice’ or ‘brown rice’. Placebo controls were foods that did not contain functional agricultural products. Test groups were three groups consuming only one test food each, and one group consuming all 3 test foods. Intake period was twelve weeks, with test foods consumed at lunchtime on weekdays. Primary endpoint was AVFA, and secondary endpoints were HbA1c and 1,5-anhydroglucitol(AG). A total of 159 participants were enrolled and there were no dropouts. Of these, 137 analysis subjects (PPS) consumed more than 80% of boxed lunches. The impact of this intervention yielded clinically and statistically significant reductions. In subgroup analysis of AVFA, among subjects in whom median of baseline AVFA was less than 127cm2, the ‘rice’ group showed a change of -7.9cm2. Among women, the AVFA of the ‘rice’ group decreased significantly by 14.9cm2 (p=0.012). The ‘Benifuuki’ tea showed significantly lower serum levels of 1,5-AG. No noteworthy side effects were noted. These results suggest that changes in eating habits and consecutive intake of functional boxed lunches have the potential to reduce AVF.</p>

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