Eight Week ad Libitum Self-prepared Paleo Diet and Cardiometabolic Disease Risk Factors in Overweight Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Serum biomarkers of energy homeostasis
研究概览
简要总结
Overweight, physically inactive but otherwise healthy adults habitually eating a traditional Western diet will follow an ad libitum self-administered Paleo diet for 8-weeks. Blood and body composition will be measured before and after the intervention period.
详细描述
The Paleo diet is a dietary method that is gaining popularity among the general population due to potential weight loss and disease prevention benefits. The feasibility of the Paleo diet and the effectiveness of self-administration in improving cardiometabolic disease risk factors remains uncertain. Examination od cardiometabolic disease risk factors in overweight, physically inactive adults before and after 8-weeks of an ad libitum self-administered Paleo dietary intervention. Methods: Overweight, physically inactive but otherwise healthy adults habitually eating a traditional Western diet follow an ad libitum self-administered Paleo diet for 8-weeks. Blood samples were analyzed for fasting cardiometabolic disease biomarkers. Participants complete three-day dietary recalls prior to, and during weeks 4 and 8 of the intervention to confirm Western diet consumption at pre-, track compliance, and to assess dietary changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-55 years
- •BMI > 25 kg/m2
- •Currently consuming a typical Western diet (high carbohydrate, low fat diet), which will be assessed using the 3-day dietary record (public domain)
排除标准
- •known cardiovascular, metabolic (including type I or type II diabetes), or respiratory disease
- •smoking and/or smokeless tobacco users
- •pregnancy
研究组 & 干预措施
Dietary intervention
All participants will follow an ad libitum self-administered Paleo diet for 8-weeks
干预措施: Diet (Other)
结局指标
主要结局
Serum biomarkers of energy homeostasis
时间窗: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum fibroblast growth factor (FGF)-21 (pg/mL) and adiponectin (pg/mL)
Serum growth factor
时间窗: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum measurement of brain derived neurotrophic factor (BDNF; ng/mL)
Serum cytokines
时间窗: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum measurement of interleukin (IL)-4 (pg/dL), IL-10 (pg/dL), interferon (INF)-gamma (pg/dL), tumor necrosis factor (TNF; pg/dL)
Serum adipokines
时间窗: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum omentin (ng/mL) and nesfatin (ng/mL)
Serum glucose metabolism biomarkers
时间窗: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
leptin (mg/dL), glucagon-like peptide (GLP)-1 (mg/dL), resistin (mg/dL), insulin (mg/dL), Gastric inhibitory polypeptide (GIP; mg/dL), glucagon (mg/dL), visfatin (mg/dL), ghrelin (mg/dL), plasminogen activator inhibitor (PAI)-1 (mg/dL), C-peptide (mg/dL)
次要结局
- Body weight(Change from pre-intervention (week zero) and post-intervention (upon completion of week 8))
- Body height(pre-intervention (week zero))
- Subcutaneous body fat(Change from pre-intervention (week zero) and post-intervention (upon completion of week 8))
- Dietary composition(Change from pre-intervention (week zero) and post-intervention (upon completion of week 8))
- Dietary energy intake(Change from pre-intervention (week zero) and post-intervention (upon completion of week 8))
- Waist and hip circumference(Change from pre-intervention (week zero) and post-intervention (upon completion of week 8))
- Blood pressure(Change from pre-intervention (week zero) and post-intervention (upon completion of week 8))
研究者
Melissa M Markofski
Asssitant Professor
University of Houston