Hydrolyzed Whey for Blood Lipid Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum cholesterol
研究概览
简要总结
The goal of this clinical trial is to learn if hydrolyzed whey protein can help serum cholesterol stay in normal range in adults. As a side inquiry, a few blood measures will be taken that are relevant to low level inflammation. The main questions the study aims to answer are:
- Will hydrolyzed whey lower serum cholesterol readings in adults with starting values in the upper end of normal to the lower end of elevated?
- Will the hydrolyzed whey affect a general measure of inflammation and two measures of indirect relevance to inflammation?
Researchers will compare hydrolyzed whey to a conventional whey (a control protein not expected to affect serum cholesterol readings) to see if the hydrolyzed whey lowers serum cholesterol.
Participants will:
- Drink one protein beverage every day for 6 weeks;
- Go to a LabCorp facility for a blood draw before and after the 6 weeks.
详细描述
Background. According to the American Medical Association and the Centers for Disease Control, nearly 94 million adults over the age of 20 have what could be considered borderline high cholesterol. Most of these people don't take drugs to lower cholesterol. Therefore, this group of people represent a target for other approaches to lowering cholesterol readings. This group can include people in the high end of acceptable range since they can run the risk of getting into borderline high readings. A nutritional product could be part of a plan to keep cholesterol readings in the normal range.
Whey protein could comprise such a product. This protein gets used in many protein powders, ready-to-drink beverages and bars. However, whey does not have a simple and consistent record for lowering cholesterol readings. Even with the studies giving positive results, only indirect effects may occur. This can happen by whey replacing fat and high glycemic index carbohydrate foods, or by impacting satiety.
In contrast, this project tests the proposition that certain versions of hydrolyzed whey can directly exert a modest but useful action on cholesterol readings. The applicant has found this in a small unpublished study in older exercisers. In addition, a retracted study has shown that in people with pre-hypertension or moderate hypertension, hydrolyzed whey can reduce total and LDL cholesterol readings. A decrease of 29 mg/dL for total cholesterol despite only moderately high starting cholesterol values).
Although this data is useful, it is based only an unpublished study and a retracted paper. Also, the two populations studied were somewhat narrow. Thus, a new study is now going to be done in a fairly broad population. Positive results in this and possible subsequent research could be applied to products quickly since no drug claim is needed. The Dietary Supplement and Education Act (DSHEA) allows for structure function claims of helping maintain blood lipids in the normal range.
As a side note, hydrolyzed whey protein could also reduce low level general inflammation. This process, which falls below what's seen with inflammatory diseases or injury, can raise the risk for many long term health problems. Drugs are not generally employed to minimize this type of inflammation. So, as with moderately high TG readings, relatively safe and inexpensive non-drug alternatives can be sought (including nutritional supplements).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 59 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cholesterol reading of 190 to 225 mg/dL
- •Age 21-59 years old
排除标准
- •Uncontrolled diabetes
- •Hypothyroidism or other hormonal problems that have not stabilized
- •Any liver diseases being actively treated
- •Renal dialysis use
- •Rheumatoid arthritis and related issues like lupus
- •Inflammatory bowel disease
- •Following a very restrictive diet
- •Low blood pressure
- •Statin drug use
- •Having more than 5 alcoholic drinks per week
- •Extreme obesity (BMI over 37)
- •Pregnancy or lactation
- •Allergies to milk protein
- •History of discomfort after consuming whey protein
研究组 & 干预措施
Standard whey
A standard whey protein is consumed daily for 6 weeks
干预措施: Standard whey (Dietary Supplement)
Hydrolyzed whey
A hydrolyzed whey protein is consumed daily for 6 weeks
干预措施: Hydrolyzed whey (Dietary Supplement)
结局指标
主要结局
Serum cholesterol
时间窗: 6 weeks
Serum total and LDL cholesterol (mg/dL) will be assessed
次要结局
- Other Blood Lipids(6 weeks)
- Inflammation markers(6 weeks)
研究者
Robert DiSilvestro
President
Medinutra LLC
