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临床试验/NCT07063056
NCT07063056招募中不适用

Curcumin and Astaxanthin for Lowering Triglyceride Readings and Inflammation

Medinutra LLC2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年7月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
64
试验地点
2
主要终点
Trilgycerides

研究概览

简要总结

Two dietary supplements are each being compared to a placebo for the ability to help maintain triglycerides in the normal range. The subjects will be adult men and women with moderately high TG values. Serum triglycerides will be measured before and after 6 weeks of taking 1 capsule per day of either Longvida Curcumin, astaxanthin, or a placebo. A few side blood analysis will also be done. These measures are relevant to low level inflammation.

详细描述

Background Moderately high readings for serum TG have been thought to place many people at risk for cardiovascular disease (CVD) and other problems. However, for a few years, doubts were expressed about high TG as an independent risk factor for CVD and maybe other problems in most people. More recently, the tide has begun to turn back due to new studies and new attention to old studies. Now, TG readings are again being thought to affect vulnerability to CVD, fatty liver, high blood sugar, and other problems including general inflammation. Some of these studies have shown evidence that TG effects can be independent of LDL or total cholesterol readings. Also, one of these studies suggest that even dropping TG readings from the top of the normal range to lower values can produce benefits.

People with TG readings between the top of the normal range to moderately high usually do not take drugs to lower TG values. Therefore, a need exists for cost effective, low side effect alternatives to help maintain normal TG readings. Nutritional supplements could fit in here. The Dietary Supplement and Education Act (DSHEA) allows for structure function claims of helping maintain blood lipids in the normal range. Low level general inflammation, which falls below what's seen with inflammatory diseases or injury, can also raise the risk for many 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).

This researcher has found that under certain conditions, two natural ingredients each lower TG readings. One ingredient is a high absorption form of curcumin extract from the spice turmeric (Longvida Optimized Curcumin®). A dose of 400 mg per day (80 mg curcumin) lowered TG levels in healthy middle aged women. Aanother group has found that a third ingredient, astaxanthin can produce a substantial drop in TG values. A dose of 12 mg/day was more effective than 6 mg but the same as 18 mg. Also of note, readings for HDL cholesterol, the so called good cholesterol, rose a little. Another astaxanthin study found a drop in TG values in people with type 2 diabetes. A TG lowering effect of astaxanthin has also been seen in animal studies.

It's doubtful that any of these three ingredients could produce the really large TG drops needed by people with very high values. Even so, for people in the borderline to moderately high range, these ingredients, especially in combination, could help maintain normal range values.

Eventually, a combination product could be made of astaxanthin + Longvida Optimized Curcumin® + the third ingredient. However, there is work to be done before that can be considered. One lacking is that three ingredients have never been tried in combination. But, even before trying that, another issue must be addressed. For all three ingredients, the human research cited above have all been done in subjects whose TG readings were good to begin with. Therefore, it is not known how these ingredients, combined or individually, will affect TG readings in people with higher starting values.

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 (Participant)

入排标准

年龄范围
21 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Triglyceride reading of 140-250 mg/dL
  • Age 21-59

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
  • Low blood pressure
  • Having more than 5 alcoholic drinks per week
  • Extreme obesity (BMI over 37)
  • Pregnancy or lactation

研究组 & 干预措施

Regular dose curcumin

Experimental

Subjects will be given 1 capsule per day of a typical amount of Longvida curcumin (80 mg curcumin)

干预措施: Curcumin (Longvida™) (Dietary Supplement)

Low dose curcumin

Experimental

Subjects will be given 1 capsule per day of 40 mg curcumin which is half the typical amount of Longvida curcumin

干预措施: Half Dose Curcumin (Longvida™) (Dietary Supplement)

Astaxanthin

Experimental

Subjects will be given 1 capsule per day of a typical amount of astaxanthin (12 mg curcumin)

干预措施: Astaxanthin (Dietary Supplement)

Control

Placebo Comparator

Subjects will be given 1 capsule per day of a small amount of cellulose

干预措施: Placebo Control (Other)

结局指标

主要结局

Trilgycerides

时间窗: Pre and post 6 week intervention

Serum triglyceride readings (mg/dL)

次要结局

  • Other blood lipids(Before and after the 6 week intervention)
  • Inflammation markers(Measures will be from blood samples taken before and after the 6 week intervention.)

研究者

发起方
Medinutra LLC
申办方类型
Other
责任方
Sponsor

研究点 (2)

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