跳至主要内容
临床试验/NCT07163078
NCT07163078尚未招募不适用

A Medical Nutrition Supplement for Cystic Fibrosis

Ohio State University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Nutrient status assessor 1

研究概览

简要总结

The goal of this study is to learn if one nutrition supplement formula works better than a different formula in adults with cystic fibrosis. The main question being addressed is: Will certain atypical versions of certain nutrients outperform typical versions of these nutrients? This will be determined by examining blood measures of nutrient levels and/or indications of nutrient function indicators pre- and post-intervention. Participants will take the supplements for 6 weeks with a blood draw before and after that time.

详细描述

Background. For people with cystic fibrosis (CF), new drugs have extended life expectancy and improved quality of life. Yet, even with these improvements, people with CF still face shorter than normal life spans and constant threats of quality of life disruptions. One approach to attacking these hardships consists of treating nutritional deficiencies. However, that's not as simple as just giving standard nutrients. People with CF have trouble transporting certain nutrients from the digestive system. In theory, giving nutrients in certain forms might get past the CF associated difficulties. However, the big question is: What forms would work?

The answer to this question can vary for different nutrients. For fat soluble vitamins D and E as well as coenzyme Q10 (CoQ10), which is vitamin-like in CF, the proposed solution may be to make the nutrients mix well with water (by using something called micellular versions). That's because these nutrients normally leave the digestive system into the blood by riding with ingested fats; that's a problem in CF because fat malabsorption occurs. Micellular forms could allow the nutrient to travel with water. Some micellular versions of fat soluble vitamins have been tested in people with CF, but the results were not ideal. A better approach could be to use nanoemulsion micellular versions of fat soluble nutrients.

For another nutrient, copper, there needs to not only be good absorption from the digestive system, but also a need to get the copper's to its functional molecules. This principal investigator for the current study has found that giving the normally well absorbed copper glycinate doesn't improve copper status in CF people. In contrast, this situation may be remedied by mixing copper glycinate with a well absorbed version of the nonessential nutrient curcumin (which could escort copper to the appropriate molecules).

Choline, an essential nutrient, can also be a concern for people with CF. Alpha-glyceryl phosphoryl (AGP)-choline may absorb better in these people than the more commonly used choline tartrate.

If the above mentioned non-standard nutrient forms can be shown to work better in people with CF, a new product could be made with the non-standard versions of vitamins D and E, CoQ10, copper, and choline. A formulation could also eventually include another 2 fat soluble vitamins as nanoemulsions as well as zinc + curcumin (since zinc may have the same problem-solution as copper). The product could also include other nutrients normally taken as part of a multi-nutrient supplement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with cystic fibrosis
  • Diagnosed with exocrine pancreatic insufficiency
  • 18 years old or older
  • Currently on modulator
  • Normal liver enzyme labs

排除标准

  • Non-English-speaking participants
  • Acute health crisis
  • Persistent elevation of liver enzymes >6 months (E2) (ALT >80 U/L)
  • History of liver abnormalities
  • If patients are currently taking Category A or Category B in the LiverTox categorization system
  • Recent vitamin D supplementation of 30 mcg/day or higher, vitamin E supplements of 200 IU/day or higher, or copper at 2 mg/day or higher
  • Any other concern by investigator that the subject is inappropriate for inclusion
  • Patients who is on a reduced dose of a CFTR modulator
  • Patients on azole antifungals (voriconazole, itraconazole, posaconzole, >7 days of fluconazole, etc.).
  • Patients who binge drink EtOH - for men more than 2 drinks/day, for women more than 1 drink/ day
  • Patients that are on other medications that are sensitive CYP3A4 substrates - such as tacrolimus for example
  • Patients on sensitive CYP3A4 substrates including but not limited to tacrolimus, sirolimus, and cyclosporine

研究组 & 干预措施

Conventional nutrient forms

Active Comparator

People are given a supplement with nutrient forms typically used in supplements

干预措施: Common form supplementation (Dietary Supplement)

Non-common nutrient forms

Experimental

People are given a supplement with nutrient forms that are not the most commonly used forms in supplements

干预措施: Uncommon nutrient supplementation (Dietary Supplement)

结局指标

主要结局

Nutrient status assessor 1

时间窗: From pre-supplementation to 6 weeks later

Plasma concentrations of 25-OH vitamin D (ng/ml)

Nutrition status assessor 3

时间窗: From pre-supplementation to 6 weeks later

Plasma concentrations of CoQ10 (mg/L)

Nutrition status assessor 2

时间窗: From pre-supplementation to 6 weeks later

Plasma concentrations of vitamin E (mg/L)

Nutrition status assessor 4

时间窗: From pre-supplementation to 6 weeks later

Plasma copper (µg/ml)

Nutrition status assessor 7

时间窗: From pre-supplementation to 6 weeks later

Plasma choline (µM)

Nutrition status assessor 5

时间窗: From pre-supplementation to 6 weeks later

Plasma diamine oxidase activity (Units/L)

Nutrition status assessor 6

时间窗: From pre-supplementation to 6 weeks later

Erythrocyte copper superoxide dismutase activities (Units/ml packed cells)

次要结局

  • Functional implication indicator 4(From pre-supplementation to 6 weeks later)
  • Functional implication indicator 1(From pre-supplementation to 6 weeks later)
  • Functional implication indicator 2(From pre-supplementation to 6 weeks later)
  • Functional implication indicator 3(From pre-supplementation to 6 weeks later)
  • Subjective response(From pre-supplementation to 6 weeks later)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert DiSilvestro

Emeritus Pofessor

Ohio State University

研究点 (1)

Loading locations...

相似试验