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临床试验/NCT01915433
NCT01915433已完成不适用

Wahls Paleo Diet and Progressive Multiple Sclerosis

Terry L. Wahls3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
3
主要终点
Perceived Fatigue

研究概览

简要总结

Based on favorable preliminary data from ongoing studies testing the safety and tolerability of a nutrition, exercise and neuromuscular electrical stimulation funded by Direct MS, the investigators are proposing a pilot study focused on the Wahls Paleo plus Diet and Wahls Diet intervention to usual care. The intent is to measure the effect size of a Wahls Paleo plus Diet and the effect size of the Wahls Diet in reducing fatigue and improving quality of life scores as measured by fatigue severity scale score and MS quality of life 54 physical and mental scores and various subscale scores. Inclusion criteria is the presence of fatigue and the diagnosis secondary and primary progressive MS, progressive relapsing MS or relapsing-remitting MS with an expanded disability status scale score (EDSS) score of 4.5 or greater but otherwise stable medically. The Wahls Paleo plus (ketogenic diet) and the Wahls diet (modified paleolithic diet) groups will be instructed in completing a daily food log and receive coaching from registered dieticians who are expert in motivational interviewing. The control group will receive usual care. Biomarkers of nutrient levels (e.g. vitamin) and inflammation, blood sugar and insulin levels will be monitored. Additional blood will be frozen for future analysis. Nutrient (e.g. vitamin and antioxidant) intake will be assessed using food frequency questionnaires and 24 hr diet recalls. Test of endothelial function will be done at baseline and 12 weeks. Outcome measures will be change in quality of life and fatigue, endothelial function and blood biomarkers between enrollment and end of study at 12 weeks. The hypotheses are that the diet intervention groups will experience reduced fatigue and improved quality of life and improved biomarkers 1) between zero and 12 weeks and that the wahls paleo plus (ketogenic diet) and the wahls diet (modified paleolithic diet) groups will experience more improvements in quality of life and reduced fatigue and in biomarkers than the usual care group experiences at 12 weeks. The usual care group will be given instruction in following both the wahls paleo plus and the wahls diet plans and how to utilize the daily food logs at the end of study visit. The usual care group will receive one nutrition coaching call to assist with implementation of the study diet.

详细描述

Specific Aim 1. To assess changes in fatigue severity (primary outcome measure) and quality of life, motor, cognitive and emotional functions (secondary measures) the intervention groups (wahls paleo plus and wahls diet group)to usual care.

Hypothesis 1a: The Wahls Paleo plus group and the wahls diet group will both demonstrate more improvements in quality of life and fatigue between baseline and 12 weeks than usual care group.

Hypothesis 1b. The wahls paleo plus group will demonstrate more improvement in quality of life and fatigue than the wahls diet group.

Specific Aim 2. To assess changes in the blood biomarkers and endothelial function as the subject progresses through the study interventions.

Hypothesis 2a: The wahls paleo plus and the wahls diet group will demonstrate more favorable changes in blood biomarkers obtained at baseline and week 12 than the usual care group.

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
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Perceived Fatigue

时间窗: Baseline, weeks, 4,8 and 12

Fatigue as measured by the fatigue severity scale and the modified fatigue impact scale

次要结局

  • Biomarkers - glucose and ketones(Baseline and at 4, 8, 12 weeks)
  • MS functional composite score.(Baseline and end of study (12 weeks))
  • Medical symptoms quest. (MSQ)(Baseline, weekly through week 12)
  • Life spaces score(Baseline and week 12)
  • Health questions(baseline)
  • MS Quality of Life (MSQoli 54)(Baseline, week 12)
  • Daily Food logs(Baseline through end of study (12 weeks))
  • Medication audit(Baseline)
  • Functional Medicine assessment summary(Baseline or 12 weeks)
  • MS Function Scale(baseline and week 12)
  • Expanded disability status score(Baseline and 12 weeks)
  • Biomarkers(Baseline and 12 weeks)
  • MS Quality of life inventory (MSQLI)(Baseline and week 12)
  • Veteran Specific Activity Quest.(Baseline and 12 weeks.)
  • 24 hr food recalls.(Baseline and 12 weeks)
  • 6 minute walk test(Baseline and week 12)
  • Satiety scale(Baseline and weeks 10 and 11)
  • Physical examination(baseline and 12 weeks)
  • Demographic data(Baseline and week 12)
  • Harvard Food Frequency Quest.(Baseline)
  • Brachial artery dilation (FMD)and endothelium-dependent dilation, EDD) and endothelium-independent dilation(Baseline and week 12)

研究者

发起方
Terry L. Wahls
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Terry L. Wahls

Study Director

University of Iowa

研究点 (3)

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