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临床试验/NCT04695418
NCT04695418已完成不适用

Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women: a Pilot Randomized Controlled Clinical Trial

Azienda di Servizi alla Persona di Pavia2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2018年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
2
主要终点
Change of body composition

研究概览

简要总结

Rice germ (RG) may be a safe and effective dietary supplement for obesity in menopause, considering its high protein content and considerable amounts of essential amino acids, good fatty acids, and fiber. This pilot randomized, blinded, parallel group, placebo-controlled pilot trial investigated the effectiveness of four weeks of RG supplementation (25 g twice a day) on body composition, measured by Dual Energy X-Ray Absorptiometry (DXA), as primary outcome, and metabolic parameters, amino acid profiles and satiating capacity, as secondary outcomes, in obese postmenopausal women following a tailored hypocaloric diet (25-30% less than daily energy requirements). Twenty-seven women were randomly assigned to the supplemented group (14) or placebo group (13). There was a significant interaction between time and group for body mass index (BMI) (p<0.0001), waist (p=0.002), and hip circumference (p=0.01), total protein (0.008), albumin (0.005), Homeostasis Model Assessment index (p=0.04), glycine (p=0.002), glutamine (p=0.004), and histidine (p=0.007). Haber's means over time showed a clearly greater feeling of satiety for the supplemented compared to the placebo group. These findings indicate that RG supplementation in addition to a tailored diet counterbalanced the metabolic changes typical of menopause, with improvements in BMI, body composition, insulin resistance, amino acid profiles and satiety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • obesity (BMI 30-40 kg/m2)
  • age 50-65
  • menopause
  • sedentary women and non-smoking,
  • women who did not drink more than six glasses (one glass: 125 mL) of wine a week and did not drink hard liquor (alcohol content at least 20% alcohol by volume)
  • women who agreed not to take part in any other weight loss program

排除标准

  • evidence of heart, kidney or liver disease
  • women who met the Diagnostic and Statistical Manual-IV (DSM-V) criteria for a current diagnosis of major depressive disorder
  • taking any medications for weight loss
  • control of cholesterol and triglycerides for anti-inflammatory purposes
  • pregnancy
  • lactating
  • Type 1 diabetes mellitus, irritable bowel disease, celiac disease, chronic pancreatitis
  • antibiotic use in the last three months
  • probiotic/prebiotic treatment in the last four weeks.

结局指标

主要结局

Change of body composition

时间窗: Baseline and 4 weeks

free fat mass (g), fat mass (g), visceral abdominal tissue (g)

次要结局

  • Change of amino acid profiles(Baseline and 4 weeks)
  • Change of inflammation markers(Baseline and 4 weeks)
  • Change of insulin resistance(Baseline and 4 weeks)
  • Change of satiating capacity(Every day for 4 weeks)
  • Change of biochemical metabolic parameters(Baseline and 4 weeks)
  • Change of anthropometric measures(Baseline and 4 weeks)

研究者

发起方
Azienda di Servizi alla Persona di Pavia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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