A Real-World Evidence Study Evaluating Quality of Life Parameters Following Use of Emergen-C
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- HALEON
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change From Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain Score at Week 12
研究概览
简要总结
The purpose of this study is to determine how Emergen-C use can improve quality of life (QoL) in a real-world setting to help consumers and healthcare professionals understand the benefits of taking Emergen-C on a routine or daily basis.
详细描述
This will be a randomized, double-blinded, placebo-controlled clinical trial to evaluate the over-time effects of 12-weeks Emergen-C supplementation on QoL parameters in a real-world setting. This study will be entirely decentralized, and participants will not be required to physically attend any on-site visits. All study data will be collected remotely through a study platform using the participant's personal mobile device, tablet or computer. Sufficient participants will be screened to enroll approximately 300 eligible participants (approximately 150 participants per group) and approximately 240 participants are expected to complete the study (approximately 120 participants per group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant's provision of a signed and dated electronic informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- •Healthy adults, 18-64 years of age at the time of electronic consent (does not exclude any ethnicities, races, or gender identities).
- •Participant is seeking to improve their energy/less fatigue levels.
- •Participants whose baseline score is greater than or equal to (>=) 10 on the dimension of general fatigue of the MFI and a score >=3 for at least ten of the 20 questions of the MFI.
- •Participants who are willing and able to comply with all study related activities as shown in the Schedule of Activities.
- •Participants who reside in the United States (except for Hawaii and Alaska).
- •Participants who own a mobile device, tablet or computer with access to stable internet connection and are willing to use their device to complete study surveys and assessments.
排除标准
- •Participants who are either directly involved in the conduct of the study or a member of their immediate family; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
- •Participants who have participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- •Participants who are pregnant, lactating, or plan to be pregnant or lactating during the course of the study (self-report).
- •Participants with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients.
- •Participants who are hypertensive or salt-sensitive should be excluded from this study.
- •Participants who report being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day).
- •Participants who are unable to read and understand English.
- •Participants who report current and/or recent (up to 3 months ago) major illnesses and/ or major surgery.
- •Participants who report a planned surgery during the study duration.
- •Participants who report a diagnosis of heart failure, heart rhythm disturbances, severe liver disease, severe mental health diagnosis, or severe renal failure.
- •Participants who report taking medications (in the previous 21 days) that have well established moderate or severe interaction with any of the study product ingredients: Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 milligrams (mg) per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, Monoamine Oxidase Inhibitors (MAOIs), or thyroid products.
- •Participants who are currently taking a multivitamin or have taken a multivitamin in the past 30 days and are not willing to stop taking a multivitamin for the duration of the trial.
- •Participants who are currently taking other Vitamin C or B supplements or have taken Vitamin C or B supplements in the past 30 days and are not willing to stop taking other Vitamin C or B supplements for the duration of the trial.
- •Participants who are currently consuming energy drinks or energy shots or have consumed an energy drink or energy shot in the past 30 days and are not willing to stop consuming energy drinks and energy shots for the duration of the trial.
- •A participant who has previously been enrolled in this study.
- •A participant who, in the opinion of the investigator or delegate, should not participate in the study.
研究组 & 干预措施
Emergen-C Core Super Orange Powder (Test Product)
Participants will be instructed to take the study product as per label instructions. Participants will consume one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
干预措施: Emergen-C Core Super Orange Powder (Dietary Supplement)
Placebo (Reference Product)
Participants will be instructed to take the study product as per label instructions. Participants will consume one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Adjusted Mean Change From Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain Score at Week 12
时间窗: Baseline and Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Week 12
时间窗: Baseline and Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Week 12
时间窗: Baseline and Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.
Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Week 12
时间窗: Baseline and Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.
Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Week 12
时间窗: Baseline and Week 12
The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.
次要结局
- Adjusted Mean Change From Baseline in MFI General Fatigue Domain Score at Weeks 4 and 8(Baseline, Week 4 and Week 8)
- Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Weeks 4 and 8(Baseline, Week 4 and Week 8)
- Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Weeks 4 and 8(Baseline, Week 4 and Week 8)
- Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Weeks 4 and 8(Baseline, Week 4 and Week 8)
- Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Weeks 4 and 8(Baseline, Week 4 and Week 8)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Fit(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel Only Able to do a Little(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Very Active(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Like Doing All Sorts of Nice Things(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Feel Tired(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do a Lot in a Day(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: When I am Doing Something, I Can Keep my Thoughts on it(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Can Take on a Lot(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Dread Having to do Things(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Think I do Very Little in a Day(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Can Concentrate Well(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I am Rested(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: It Takes a Lot of Effort to Concentrate on Things(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in a Bad Condition(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Have a Lot of Plans(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Tire Easily(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Get Little Done(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: I Don't Feel Like Doing Anything(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: My Thoughts Easily Wander(Baseline, Weeks 4, 8 and 12)
- Adjusted Mean Change From Baseline in Each of the Item Score in the MFI at Weeks 4, 8 and 12: Physically I Feel I am in an Excellent Condition(Baseline, Weeks 4, 8 and 12)
- Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Family Support(Baseline, Weeks 4, 8 and 12)
- Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Resilience(Baseline, Weeks 4, 8 and 12)
- Change From Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Ability to Relax and Unwind(Baseline, Weeks 4, 8 and 12)