极低卡路里生酮饮食的疗效和安全性：一项双盲随机交叉研究。

Efficacy and safety of very-low-calorie ketogenic diet: a double blind randomized crossover study.

机构信息

CNR, IBFM UOS of Germaneto, University "Magna Graecia" of Catanzaro, Campus "Salvatore Venuta", Catanzaro, Italy.

出版信息

Eur Rev Med Pharmacol Sci. 2017 May;21(9):2274-2289.

Abstract

OBJECTIVE

To verify safety respect to weight loss, cardiometabolic diseases of short-term Very low-calorie ketogenic diets (VLCKDs, <800 kcal day-1).

PATIENTS AND METHODS

Randomized cross-over trial with placebo. The study had no. 2 dietary treatment (DT), conducted in two arms: (1) VLCKD1 in which 50% of protein intake is replaced with synthetic amino acids; (2) VLCKD2 with placebo. The VLCKDs (<800 kcal day-1) were different in term of protein content and quality each arm lasted three weeks (wks). Between the two arms a 3-wks washout period was performed to avoid additive effects on DT to follow. At the baseline, at start and end of each arm, all the subjects were evaluated for their health and nutritional status, by anthropometric analysis, body composition (Dual X-ray Absorptiometry (DXA), Bioimpedentiometry, biochemical evaluation, and Peroxisome Proliferator-Activated Receptor γ (PPAR) γ expression by transcriptomic analysis.

RESULTS

After VLCKD1 were reduced: Body Mass Index (BMI) (Δ%=-11.1%, p=0.00), Total Body Water (TBW) (p<0.05); Android Fat Percentage (AFP) (Δ%=-1.8%, p=0.02); Android Fat Mass (AFM) (Δ%=-12.7%, p=0.00); Gynoid Fat Mass (GFM) (Δ%=-6.3%, p=0.01); Intermuscular Adipose Tissue (IMAT) (Δ%= -11.1%, p=0.00); Homeostasis Model Assessment of Insulin Re-sistance (HOMA-IR) (Δ%=-62.1%, p=0.01). After VLCKD1 a significant increase of uricemia, cre-atinine and aspartate aminotransferase (AST) (respectively Δ%=35%, p=0.01; Δ%=5.9%, p=0.02; Δ%=25.5%, p=0.03). After VLCKD2 were reduced: BMI (Δ%=-11.2%, p=0.00); AFM (Δ%=-14.3%, p=0.00); GFM (Δ%=-6.3%, p=0.00); Appendicular Skeletal Muscle Mass Index (ASMMI) (Δ%=-17.5%, p=0.00); HOMA-IR (Δ%=-59,4%, p=0.02). After VLCKD2, uricemia (Δ%=63.1%, p=0.03), and Vitamin D levels (Δ%=25.7%, p=0.02) were increased. No significant changes of car-diovascular disease (CVD) indexes were observed after DTs. No significant changes of PPARγ lev-el in any DTs.

CONCLUSIONS

21-days VLCKDs not impair nutritional state; not cause negative changes in global measurements of nutritional state including sarcopenia, bone mineral content, hepatic, renal and lipid profile.

摘要

目的

验证短期极低卡路里生酮饮食（VLCKD，<800 卡路里/天）在减肥和代谢疾病方面的安全性。

患者和方法

这是一项随机交叉试验，设安慰剂对照。研究共进行了 2 种饮食处理（DT），分为两个臂：（1）VLCKD1，其中 50%的蛋白质摄入由合成氨基酸替代；（2）VLCKD2，使用安慰剂。两种 VLCKD 的（<800 卡路里/天）在蛋白质含量和质量上有所不同，每个臂持续 3 周（wks）。在两个臂之间进行 3 周的洗脱期，以避免对随后的 DT 产生累加效应。在基线、每个臂的开始和结束时，通过人体测量分析、身体成分（双能 X 射线吸收法（DXA）、生物电阻抗法、生化评估和过氧化物酶体增殖物激活受体 γ（PPAR）γ表达的转录组分析评估所有受试者的健康和营养状况。

结果

在 VLCKD1 后，体重指数（BMI）（%变化=-11.1%，p=0.00）、总体水分（TBW）（p<0.05）、安卓脂肪百分比（AFP）（%变化=-1.8%，p=0.02）、安卓脂肪质量（AFM）（%变化=-12.7%，p=0.00）、臀肌脂肪质量（GFM）（%变化=-6.3%，p=0.01）、肌肉间脂肪组织（IMAT）（%变化=-11.1%，p=0.00）、稳态模型评估的胰岛素抵抗（HOMA-IR）（%变化=-62.1%，p=0.01）。在 VLCKD1 后，尿酸、肌酐和天冬氨酸氨基转移酶（AST）显著升高（分别为%变化=35%，p=0.01；%变化=5.9%，p=0.02；%变化=25.5%，p=0.03）。在 VLCKD2 后，BMI（%变化=-11.2%，p=0.00）、AFM（%变化=-14.3%，p=0.00）、GFM（%变化=-6.3%，p=0.00）、四肢骨骼肌质量指数（ASMMI）（%变化=-17.5%，p=0.00）、HOMA-IR（%变化=-59.4%，p=0.02）降低。在 VLCKD2 后，尿酸（%变化=63.1%，p=0.03）和维生素 D 水平（%变化=25.7%，p=0.02）升高。DT 后心血管疾病（CVD）指标无明显变化。任何 DT 中 PPARγ 水平均无显著变化。