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临床试验/NCT04327141
NCT04327141进行中(未招募)不适用

Comparison of Protein Pacing, Intermittent Fast vs. Heart Healthy Diet on Body Weight and Composition, Cardiometabolic, Mood, and Gut Microbiome Health, in Overweight Men and Women During Weight Loss; 24 Months Follow-up Case Study of 100 Pound Weight Loss in a Male Study Participant

Skidmore College2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
Change in body weight

研究概览

简要总结

This study will systematically quantify the effects of protein pacing and intermittent fasting (P-IF) on total and regional (abdominal) body composition (lean mass and fat mass), blood glucose and lipids, and anti-aging biomarkers, hunger ratings, and the gut microbiome in 40 overweight/obese adult men (n=20) and women (n=20) following a 8-week weight loss intervention. Participants will be enrolled in the study as a single cohort and participate in a 8-week weight loss (WL) trial consisting of a single dietary intervention phase. The purpose of the additional 12 month follow up case study (in addition to the initial 12-month case study period) is to scientifically document a significant weight loss and improved body composition following combined protein pacing intermittent fasting nutrition and a safe, effective exercise program in a study participant who achieved successful weight loss maintenance during the previous 12 month follow up study period.

详细描述

Previous research has shown combined protein pacing and intermittent fasting (PP-IF; 1-2 days per week) combined with moderate (20-30%) caloric restriction (CR) favorably enhance weight loss, body composition, cardiometabolic disease risk, oxidative stress, and toxin levels compared to a heart healthy diet in obese individuals following both weight loss and weight loss maintenance (Arciero et al. 2016; He et al. 2017; Zuo et al. 2016). However, less is known about whether a low sugar intake with this dietary pattern induces other significant health improvements, such as enhanced brain health (mood state), as well as gut microbiome and anti-aging indices, compared to a heart healthy diet. The novelty of the current proposal is of particular relevance and importance given the heightened popularity of low sugar dietary patterns shown to enhance health status. Most notably, among these low sugar diets touting the health benefits, are the ketogenic, paleolithic and Mediterranean diets. In addition, there is a great deal of public health emphasis on reducing overall carbohydrate intake, especially simple sugars, to improve cardiometabolic, gut, and body composition health. The dangers of high simple sugar intake are numerous, including increased risk for cardiometabolic disease (high blood lipids, hyperglycemia, insulin resistance, systemic inflammation, oxidative stress, obesity, elevated visceral fat, etc.). Thus, improvements in body composition and reductions in disease risk provides compelling evidence to pursue this study with vigor so as to generate a viable and healthy weight and fat loss strategy over the long term. Another major factor to augment long-term (>1 year) weight loss success, is inclusion of a safe and realistic exercise program (4 days/week) consisting of walking, stretching, and simple body weight movements such as sit-ups and push-ups. To date, there are no documented case studies of a human participant achieving a one hundred pound plus weight loss using protein pacing and intermittent fasting combined with a proven, safe and time-efficient exercise program.

The purpose of this study is to compare the effects of a low sugar protein pacing, intermittent fasting (P-IF) diet versus a heart healthy (HH) diet on indices of body weight, total and regional body composition, mood state, anti-aging, and cardiometabolic outcomes, and the gut microbiome during weight loss (0-8 weeks). Specifically, this study aims to compare a P-IF diet comprised of a calorie-restricted (1500 calories/day women; 1800 calories/day men) protein pacing diet (P, 4 meals/day women, 5 meals/day men) followed by a fast (IF, ~350-450 kcals/day) compared to an established calorie-restricted (1200 calories/day for women; 1500 calories/day men) heart healthy (HH) diet. The P-IF group will be divided into two subgroups for weeks 1-4. One subgroup will consist of five days of P and two days of IF, and the second subgroup will consist of six days of P and one day of IF. For weeks 5-8 both subgroups will follow 6 days of a P diet and 1 day IF. The purpose of the additional 12 month follow up case study (in addition to the initial 12-month case study period) is to scientifically document a significant weight loss and improved body composition following combined protein pacing intermittent fasting nutrition and a safe, effective exercise program in a study participant who achieved successful weight loss maintenance during the previous 12 month follow up study period.

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
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-smoking, healthy, but overweight/obese men and women with no known cardiovascular or metabolic diseases as assessed by a medical history and a comprehensive medical examination by their physicians
  • Sedentary or lightly active (<30 min, 2d/wk of structured physical activity) as assessed by a Physical Activity questionnaire
  • Overweight or obese (BMI>27.5 kg/m2; % body fat>30%)
  • Weight stable (+/-2kg) for at least 6 months prior to beginning the study

排除标准

  • Type II Diabetes
  • Emphysema
  • Significant heart disease (CABG, CHF, VFib, Hypercholesterolemia, Uncontrolled High Blood Pressure, etc.)
  • Cancer or undergoing treatment for cancer
  • Allergies to milk or milk products, sugar alcohols, fructose, or gluten
  • Anorexia or Bulimia
  • Fasting intolerances/hypoglycemia
  • Pregnant or plan to become pregnant during 8-week study

结局指标

主要结局

Change in body weight

时间窗: 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study

Total body weight measurement

次要结局

  • Change in fat mass and muscle mass(0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study)
  • Change in physical activity(0 weeks, 4 weeks, 8 weeks, and monthly intervals during the 2 year of the Case study)
  • Change in total and regional body fat and lean body mass(0 weeks, 8 weeks, 1 year and 2 year of the Case study)
  • Changes in feelings of hunger, fullness, satiety scores measured with a visual analog scale(0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study)
  • Change in energy intake(0 weeks, 4 weeks, 8 weeks, and monthly intervals during the 2 year of the Case study)
  • Change in blood lipid levels(0 weeks, 4 weeks, 8 weeks and every 6 months during the 2 year Case Study)
  • Change in heart rate(0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study)
  • Change in gut microbiome, gastrointestinal symptoms, stool(0 weeks, 4 weeks, 8 weeks and two month intervals during the 2 year Case Study)
  • Change in blood pressure(0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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