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临床试验/NCT05282355
NCT05282355已完成不适用

Astaxanthin Reduces Exercising Heart Rate by 7% in Overweight Individuals.

University of North Alabama1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年5月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
1
主要终点
Changes to substrate oxidation rates

研究概览

简要总结

Briefly, this study involved 2 trials: baseline (Trial 1) and post-astaxanthin intervention (Trial 2). Both trials included participants completing a graded exercise test while connected to a metabolic cart, to measure cardiorespiratory measures. Between trials, participants were supplemented with either 12 mg of astaxanthin or placebo for 4 weeks. It was hypothesized astaxanthin supplementation would increase rates of fat oxidation, while decreasing carbohydrate oxidation and blood lactate accumulation.

详细描述

METHODS

Experimental Design

The current study implemented a double-blind, between-subject study design with dependent variables examined at multiple timepoints across each trial. To best observe changes in our selected dependent variables, subjects reported to the laboratory on two separate occasions (i.e. pre-post) following 4 weeks of astaxanthin supplementation.

Subject Approval from the Institutional Review Board was granted before recruiting subjects (University of North Alabama, Institutional Review Board #: 20-21-071). Each subject completed a Physical Activity Readiness Questionnaire, a medical questionnaire, and provided their written and verbal consent to voluntarily participate in the present study. Inclusion criteria for each subject included the following: 1) between the ages of 18-45; 2) free of any cardiometabolic disease medication; 3) classified as overweight with a bodyfat percent of ≥ 20% for males and ≥ 25% for females; 4) and not currently pregnant or actively trying to become pregnant. Additionally, subjects eliminated all dietary supplements at least two weeks prior to the start of the study. Using G-Power software and changes to bodyfat as a primary dependent variable, we determined a priori that 20 subjects would be sufficient to achieve a desired power of 0.85, using a moderate-high effect size, and an alpha level set at 0.05. Although 46 individuals were recruited, only 21 fit the inclusion criteria and were randomized into either an astaxanthin or placebo group following their first visit. Due to two participants withdrawing from the study as a result of health concerns not related to the study procedures, 19 subjects were included in statistical analysis.

Preliminary Data During the first visit, subjects had their body composition assessed via bioelectrical impedance analysis as well as height, mass, and blood pressure by the same, trained investigator pre-post intervention. Following the collection of anthropometric data, subjects who met inclusion and exclusion criteria were then asked to attempt to maintain their current dietary habits for the duration of the intervention. Dietary intake was then recorded pre-post intervention via 3-day food logs which consisted of 2 weekdays and 1 weekend day (i.e. Thursday, Friday, Saturday) to better reflect typical intakes. Subjects met with the primary investigator and were instructed how to complete the food logs, regarding quantity size and liquid amount estimations. Total energy intake, carbohydrate, protein, and fats were analyzed for nutrient amounts using MyFitnessPal and were then used in statistical analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Participants were blinded to either the supplement or placebo. The capsules were identical in appearance and size. Blinding was accomplished via an investigator not directly involved with data collection.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Free of any cardiometabolic disease medication
  • •Classified as overweight - body fat % ≥ 20% (M) and ≥ 25% (F)
  • •Exclude dietary supplements for 2 weeks prior to start of study

排除标准

  • •If there is a chance of pregnancy
  • •body fat % < 20% (M) and < 25% (F)

研究组 & 干预措施

Placebo

Placebo Comparator

The placebo group ingested two capsules per day, one in the morning and one in the evening. Each capsule contained sunflower oil and mimicked the size and appearance of the astaxanthin supplement.

干预措施: Placebo (Dietary Supplement)

Astaxanthin

Experimental

The astaxanthin group received 12 mg/day of astaxanthin. Each capsule contained 6 mg of astaxanthin and sunflower oil, and each subject ingested one capsule in the morning and one in the evening.

干预措施: Astaxanthin (Dietary Supplement)

结局指标

主要结局

Changes to substrate oxidation rates

时间窗: Up to 4 weeks

Substrate oxidation rates reflect cellular utilization of carbohydrates and lipids at rest and during exercise. If changes exist from astaxanthin supplementation, they would manifest themselves likely via increases to rates of fat oxidation at all stages and a subsequent decrease in carbohydrate oxidation rates at each stage.

次要结局

未报告次要终点

研究者

发起方
University of North Alabama
申办方类型
Other
责任方
Sponsor

研究点 (1)

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