The Diet Composition and Energy Balance Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change From Baseline in Body Weight
研究概览
简要总结
The purpose of the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month.
详细描述
Dose: Participants are to consume 1 unit per day of the study product.
Diet: Participants will receive no instructions for other dietary modifications; i.e., they will not be told to modify what or how much other food they consume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 20 - 40
排除标准
- •Diabetes (Type 1 or 2)
- •Prediabetes
- •Active cancer
- •Serious digestive disorders
- •Other conditions that affect metabolism or body weight
- •Uncontrolled Thyroid disorder (controlled = 6 months of medication)
- •Unable to consume study foods
- •Non- weight stable (more than 10 lbs weight gain or loss in last 6 months)
- •Pregnancy
- •Intentions of becoming pregnant in the next 2 months
- •Women who have undergone partial hysterectomy with intact ovary function
- •Current or past alcohol or drug abuse problem
- •Allergy or intolerance to study product ingredients.
- •Any other medical, psychiatric or behavioral factors that in the judgment of the Principle Investigator that may interfere with study participation or the ability to follow the protocol
研究组 & 干预措施
Sugar Sweetened Solid Treatment
A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink.
干预措施: Sugar Sweetened Solid Treatment (Other)
Sugar Sweetened Beverage Treatment
20 oz. carbonated sugar sweetened beverage. Added ingredients include: ~2.1g whey protein powder.
干预措施: Sugar Sweetened Beverage Treatment (Other)
结局指标
主要结局
Change From Baseline in Body Weight
时间窗: 1 month
Change from baseline in body weight at 1 month
次要结局
未报告次要终点
研究者
John Apolzan
Assistant Professor
Pennington Biomedical Research Center