A Two Stage, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Kinetics and Efficacy of Twice-Daily Repeat Intake of 1110 mg of Hoodia Gordonii Purified Extract (PYM50717)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Safety and tolerability of 2 and 15 day repeat consumption of Hoodia gordonii Purified Extract (H.g.PE)
研究概览
简要总结
The objective of this clinical study was to assess the safety, tolerability, efficacy (effects on appetite scores, food intake) and plasma kinetics of Hoodia gordonii purified extract (H.g.PE), when consumed twice-daily for 2 or 15-days.
详细描述
A two stage randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, kinetics and efficacy of twice-daily repeat intake of formulated Hoodia gordonii purified extract (H.g.PE) (PYM50717) administered twice daily for 2 or 15 days to healthy, overweight females aged 18 to 50 years with a body fat of 25-45%.
Stage 1 (pilot): Placebo controlled, double blind comparison to assess the effect of timing of product administration (i.e. breakfast and lunch vs breakfast and dinner).
Stage 2 (main study): Placebo controlled double blind comparison with product administered with breakfast and dinner.
A total of 64 subjects were included in this study; stage 1: n=15, stage 2: n=49. Treatment groups in stage 2 were matched for percentage body fat.
Stage 1:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females between the ages of 18 and 50 years.
- •Body fat between 25% and 45% as assessed by Dual Energy X-ray absorptiometry (DEXA) scan at Screening.
- •Stable body weight for at least two months prior to Screening (weight loss or gain >5% was considered unstable).
- •Regularly consumed at least three meals per day, including breakfast.
- •Agreed to abstain from strenuous exercise throughout the entire study.
排除标准
- •Subjects who were pregnant, lactating or were not willing to use two contraceptives (including at least one barrier contraceptive) starting at least 14 days before study product administration (Day 1) and until at least 30 days following study product administration (except subjects who were surgically sterilized or were more than one year post-menopausal).
- •Subjects who were taking any prescription or over the counter medications (with the exception of hormonal contraceptives) (including supplements, especially as related to weight management [eg, ephedrine, caffeine, synephrine]) within one week prior to Visit 2 (Day 1), or antibiotics <3 months prior to Day 1, or planned to do so during the course of the study.
- •Smokers, or ex-smokers who smoked any cigarettes in the past six months prior to study product administration and/or who used another form of nicotine-containing product.
- •Fasting blood glucose > 7 mmol/L (126 mg/dL) at Screening.
- •Psychiatric disorders that could have interfered with the subject's compliance to the requirements of the protocol, at the discretion of the Investigator.
- •Used or planned to use any medically prescribed diet or weight-loss diet or made any attempt to control diet at Screening and during the entire study.
- •Strenuous exercise >5 hours per week (eg, sports).
- •Restrained eating behavior determined by a score of ≥16 on the Revised Restraint Scale
- •a low score on the Food Action Rating Scale
结局指标
主要结局
Safety and tolerability of 2 and 15 day repeat consumption of Hoodia gordonii Purified Extract (H.g.PE)
时间窗: 41 days
Safety and tolerability (Adverse Events (AEs), vitals signs, Electrocardiogram (ECG), laboratory assessments) of twice daily consumption of 1110 mg of formulated Hoodia gordonii purified extract (H.g.PE) consumed over a period of 2 or 15 days were assessed up to 41 days after start of the intervention
Efficacy of 15-day repeat consumption of H.g.PE
时间窗: 15 days
Efficacy of twice daily consumption of 1110 mg of formulated H.g.PE during 15-day repeat intake was assessed. Appetite scores, ad libitum energy intake, body weight and body composition were assessed during the 15-day intervention.
次要结局
- Assessment of the pharmacokinetics of PYM50057 a marker of the steroid glycosides in H.g.PE(41 days)