Effect of Different Supplement Formulations on Nutrient Absorption in Otherwise Healthy Participants: a Randomised, Parallel-group Study With Double-blinded Omega-3 and Single-blinded Vitamin D3
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Part A: serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3)
研究概览
简要总结
The goal of this interventional study is to compare the absorption of supplements with and without absorption enhancing technology in healthy volunteers. We will be testing vitamin D3 and omega 3 in both males and females 18 years and older. Part A will comprise of two arms receiving a single dose of omega-3 supplement, and two arms who will receive vitamin D3 supplement daily for 7 days. Part B comprises of two arms who will receive vitamin D3 supplement daily for 6 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind omega-3 sub-study and a single-blind vitamin D3 sub-study, with blinded laboratory analysis and blinded statistical analysis
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Adults 18 years and older
- •Generally healthy
- •BMI 18.5-29.9 kg/m2
- •Able to provide informed consent
- •Agree to not participate in another clinical trial while enrolled in this trial
- •Agree not to change current diet and/or exercise frequency or intensity during entire study period
- •Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points
排除标准
- •Have a serious illness e.g. mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
- •Have an unstable illness e.g. diabetes and thyroid gland dysfunction
- •Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- •Significant change in diet in the past 1-month (e.g., removal of a food group or calorie restriction)
- •Active smokers, nicotine use or drug (prescription or illegal substances) abuse
- •Chronic past and/or current alcohol use (>21 alcoholic drinks week)
- •Pregnant or lactating women
- •Allergic to any of the ingredients in enhanced or standard formula
- •Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month (excluding RDC Clinical trials)
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Regular use within the past 4 weeks of supplements containing the trial product
- •The above criteria apply, plus baseline serum 25(OH)D <20.0 ng/mL (<50.0 nm/L)
研究组 & 干预措施
Comparator Omega 3
Participants will have a single dose containing 315mg EPA and DHA
干预措施: Comparator Omega 3 (Dietary Supplement)
Plexosome® Vitamin D3
Participants will have 1000IU vitamin D3 each day for 7 days.
干预措施: Plexosome® Vitamin D3 (Dietary Supplement)
Comparator Vitamin D3
Participants will have 1000IU vitamin D3 each day for 7 days.
干预措施: Comparator Vitamin D3 (Dietary Supplement)
Plexosome® Vitamin D3 6 weeks
Participants will have 1000IU vitamin D3 each day for 6 weeks.
干预措施: Plexosome® Vitamin D3 6 weeks (Dietary Supplement)
Comparator Vitamin D3 6 weeks
Participants will have 1000IU vitamin D3 each day for 6 weeks.
干预措施: Comparator Vitamin D3 6 weeks (Combination Product)
Aquacelle® Omega 3
Participants will have a single dose containing 315mg EPA and DHA.
干预措施: Aquacelle® Omega 3 (Dietary Supplement)
结局指标
主要结局
Part A: serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3)
时间窗: Baseline to day 7
Baseline-corrected values in serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3)
Part A: serum/plasma absorption (AUC) of the trial product t0-t24 (omega-3)
时间窗: Baseline to day 2
Baseline-corrected values in serum/plasma absorption (AUC) of the trial product t0-t24 (omega-3)
Part B: Baseline-corrected serum 25(OH)D AUC (0-6 weeks)
时间窗: Baseline to 6 weeks
Baseline-corrected serum 25(OH)D AUC (0-6 weeks)
次要结局
- Part A: Tolerability(Baseline to day 7)
- Part A: Participant demographics(Baseline)
- Part A: Serum/plasma absorption (AUC) of the trial product t0-t8 (vitamin D3)(Baseline to 8 hours)
- Part A: serum/plasma absorption (AUC) of the trial product t0-t24 (vitamin D3)(Baseline to day 2)
- Part A: Serum/plasma absorption (AUC) of the trial product t0-t48 (vitamin D3)(Baseline to day 3)
- Part A: Serum/plasma absorption (AUC) of the trial product t0-t10 (omega-3)(Baseline to 10hours)
- Part A: Change and absolute Tmax (vitamin D)(Baseline to day 7)
- Part A: Change and absolute Cmax (vitamin D)(Baseline to day 7)
- Part A: Change and absolute Tmax (omega-3)(Baseline to day 2)
- Part A: Change and absolute Cmax (omega-3)(Baseline to day 2)
- Part A: Safety via AE monitoring(Baseline to day 7)
- Part B: Change from baseline at week 6, standard vs enhanced formulation(Baseline to week 6)
- Part B: Weekly 25(OH)D change(Baseline to week 6)
- Part B: Weekly cholecalciferol change(Baseline to week 6)
- Part B: Demographics(Baseline)
- Part B: Tolerability(Baseline to week 6)
- Part B: Safety (E/LFT)(Baseline to week 6)