NCT00574574已完成不适用
Biological Effects of an Anthocyanin Rich Dietary Supplement on Skin Ageing and Markers of Inflammation in Post-Menopausal Women
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period.
研究概览
简要总结
The purpose of this study is to determine whether short-term exposure to a compound found in some fruits and vegetables (anthocyanin), is effective in improving skin health and reducing the levels of various markers of cardiovascular disease risk. A range of skin health parameters are being studied and volunteers are also providing skin biopsy, urine and blood samples. 62 postmenopausal women have been recruited for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Upper age limit of 70 years
- •Minimum of 1 year since last menstruation
- •Not taking Hormone Replacement Therapy (HRT), and not having taken HRT for a minimum of 6 months prior to commencement
- •Having no significant past or present medical history of: inflammatory conditions (including eczema, asthma, hay fever, IBS, crohn's disease and arthritis), diabetes, hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, thyroidal or psychiatric disease.
- •Agreeing to restrict dietary intake of anthocyanin containing foodstuffs and also other foodstuffs considered to be cardio-protective i.e. red wine, total alcohol, oily fish, dark chocolate, tea and coffee.
- •Agreeing to maintain existing cosmetic and beauty regime, and avoid 'tanning' (either naturally or synthetically) of the specific sites of skin function measurement during the study.
- •BMI 20-32 kg/m2
- •Successful biochemical, haematological and urinalysis assessment
排除标准
- •allergy / sensitivity to local anaesthetic i.e. Xylocaïne
- •Regular use of aspirin, or other anti-inflammatory pain relief medication, as prescribed by a doctor. [If subjects are regular self prescribed aspirin users and are willing to give up aspirin 2 months prior to the study and for the duration of the study they can be included.]
- •Taking other counter indicative medication e.g. steroidal medication during the trial, or within 1 month of the trial beginning.
- •Taking food / dietary supplements e.g. vitamins, minerals, fish oils, plant oils, isoflavones, soy products, carotenoids during the trial (unless prepared to cease intake during, and 1 month preceding the trial).
- •Those on therapeutic diets or following weight-loss diet.
- •Current smoker, or smoker in the past year
- •Having vaccinations or antibiotics within 3 months of start of trial, and those with vaccinations scheduled for during the trial
- •Parallel participation in another research project which involves dietary intervention and/or sampling of biological fluids/material
- •Participation in another research project within the last four months unless the total amount of combined blood from both studies will not exceed 470ml.
- •Those intending to travel during the study to locations where a change in skin colour may be anticipated
- •Subjects intending to deliberately "sunbathe", use tanning solariums or tanning creams on body sites used for assessment.
- •Assessed from the clinical screening
- •abnormal renal function (Na >145mmol/L, K >5.0mmol/L, Urea >7.1mmol/L, Albumin >50g/L, Creatinine >125μmol/L, Total bilirubin >22μmol/L), or liver function (ALP >126 IU/L, ALT >50 IU/L), lipid profile (Total cholesterol > 6.5 mmol/l, TAG >3.0 mmol/l, HDL>2.0 mmol/l), anaemia (Haemoglobin <11.5g/dL), fasting glucose (> 6.1 mmol/l) or measurements considered to be counter indicative of the trial outcome measures.
- •Untreated hypertension (>160/90mmHg) or hypotension (90/50mmHg or 95/50mmHg if symptomatic)
- •BMI <19.5 or >32.5
研究组 & 干预措施
1
Experimental
500mg/d of anthocyanin, contained in 4 X 250mg capsules (125mg anthocyanin/ capsule). 2 capsules to be taken with food, twice per day (n=4 in total).
干预措施: anthocyanin (Dietary Supplement)
2
Placebo Comparator
500mg/d of placebo control containing no anthocyanin, 2 X 250mg capsules to be taken with food, twice per day (n=4, 250mg capsules in total / d).
干预措施: anthocyanin (Dietary Supplement)
结局指标
主要结局
Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period.
时间窗: 12 Weeks
次要结局
- Measure: Evidence of significant differences in inflammatory status, between active treatment and placebo supplementation period.(12 Weeks)
研究者
研究点 (1)
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