The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioActor
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- 6 Minute Walking Test
研究概览
简要总结
The primary objective of this study is to determine the effect of daily supplementation of a combined orange- and pomegranate extract for a period of 4 weeks on physical fitness compared to placebo.
In this crossover study, participants will daily receive either a placebo or Actiful®, a supplement containing 500 mg orange extract and 200 mg pomegranate actives, for 4 weeks followed by a wash-out period of 4 to 8 weeks. Subsequently, the second intervention period of 4 weeks (active product or placebo) will take place. The product and placebo will be supplied in capsules that participants can ingest with a glas of water (daily, prior to breakfast).
详细描述
Dietary habits and physical activity are two important components of a healthy lifestyle. Targeted nutritional interventions may improve health and stimulate physical activity. Both orange extracts and pomegranate concentrate have been shown to exert beneficial effects on health and exercise performance. However, the effects of a combination of the two extracts on exercise and physical activity have not been investigated yet. It is expected that this combination may be an effective dietary way to improve exercise performance, physical activity in the free-living state, and quality of life in a middle aged population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60 - 75 years old
- •non smoking
- •BMI 18 -28 kg/m²
排除标准
- •Allergy to test product/placebo or citrus fruits
- •BMI lower than 18 or higher than 28
- •Recent muscle injury in less than one month before the start of the study
- •Inability to perform the fitness tests
- •Medical conditions that might influence outcome measure or participant safety during testing, including but not limited to: severe cardiovascular disease, cancer, Parkinson's disease. To be decided by PI.
- •High blood pressure (systolic ≥ 140 mmHg, diastolic ≥ 90 mmHg)
- •Use of medication that may interfere with the study results, use of beta-blockers
- •Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- •Abuse of products; alcohol (> 20 alcoholic units per week) and drugs
研究组 & 干预措施
Actiful
a supplement containing 500 mg orange extract and 200 mg pomegranate actives
干预措施: Actiful (Dietary Supplement)
Placebo
Maltodextrin
干预措施: Placebo (Other)
结局指标
主要结局
6 Minute Walking Test
时间窗: 0-4-8-12 weeks
Participants have to walk for 6 minutes, as fast as possible. Total distance will be measured.
次要结局
- Senior Fitness test(0-4-8-12 weeks)
- Concentration of blood marker TAC(0-4-8-12 weeks)
- Daily physical activity measured by accelerometers(0-4-8-12 weeks)
- Quality of life questionnaire - WHOQOL-100(0-4-8-12 weeks)