A Randomized, Triple-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy of Vinh Wellness Collagen on Skin Elasticity, Wrinkles, and Moisturizing Effect
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Cheek skin elasticity
研究概览
简要总结
The most visible signs of aging are on the skin. As skin gets older it shows a decrease in epidermal thickness, with a flattening of the dermal-epidermal junction. At the same time, loss of elasticity and wrinkle formation begin. The objective of this randomized, triple-blind, placebo-controlled study is to evaluate the efficacy of Vinh Wellness Collagen on skin elasticity, wrinkles, and hydration over 12 weeks.
详细描述
Skin appearance is known to be influenced by endogenous and environmental factors, including nutrition, hormones, as well as exposure to chemicals, smoking, or ultraviolet radiation. The ability of nutritional supplements to enhance skin characteristics has received increasing attention as the population continues aging. A recent study assessed the correlation between nutrient consumption and skin-aging appearance, including skin wrinkles, dryness, and atrophy, and determined that higher intake of linoleic acid and vitamin C, as well as lower intake of fats and carbohydrates are linked with improved skin appearance. Moreover, clinical trials examining the effects of nutritional supplementation with proteins, vitamins, fatty acids, and trace minerals, have suggested that dietary compounds can modulate skin health and function.
As skin gets older it shows a decrease in epidermal thickness, with a flattening of the dermal-epidermal junction. The dermis is the skin layer directly below the epidermis and has decreases in thickness by about 1% per year throughout the adult lifespan. Structural components of the dermis include collagen, elastic fibers, and extrafibrillar matrix. The cosmetic industry has focused its research on supporting these connective tissue components, as they have been established to repair skin damage (i.e. wounds) and enhance the strength and radiance of the skin.
Collagen is the most abundant protein in mammals and is currently being utilized by a diverse number of industries including nutrition, cosmetic, and biomedical fields. Gelatin, which is used extensively in the food sector, is a hydrolyzed analog of collagen and is an excellent source of protein. A subsequent enzymatic degradation of gelatin results in the generation of collagen hydrolysate (CH), which contains peptides of an average molecular weight of 3-6 kDa. Human bioavailability studies have demonstrated that hydrolyzed collagen peptides are present in the blood within 2 h following oral ingestion of gelatin derived from chicken or fish and are present up to 24 h later.
A double-blind, placebo-controlled trial on 69 women treated with a daily CH treatment or placebo for 8 weeks reported that skin elasticity was significantly improved. Skin moisture and skin evaporation were also enhanced but did not reach statistical significance relative to the placebo group. In addition, other studies have examined the effect of daily ingestion of CH (10 g) or placebo on skin hydration in healthy Japanese women over 2 months and found that there was a gradual improvement in skin water absorption capacity. The objective of this randomized, triple-blind, placebo-controlled study is to evaluate the efficacy of Vinh Wellness Collagen, a CH derived from pangasius skin, on skin elasticity, wrinkles, and hydration over 12 weeks of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 45 to 60 years
- •BMI between 20.0-29.9 kg/m2 (±1 kg/m2)
- •Female participant was not of child bearing potential, defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation, or are post-menopausal (natural or surgically with > 1 year since last menstruation)
- •Females of childbearing potential agreed to use a medically approved method of birth control and have a negative urine pregnancy test result. A minimum of 3-months stable dose was required for females on a hormonal birth control. Acceptable methods of birth control included:
- •Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- •Double-barrier method
- •Intrauterine devices
- •Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- •Vasectomy of partner (shown successful as per appropriate follow-up)
- •Healthy as determined by laboratory results, medical history, and physical exam
- •No known medical or psychological condition that in the investigator's opinion would interfere with study participation
- •Has given voluntary, written, informed consent to participate in the study
- •Displayed visible signs of natural and photoaging in the face, as assessed through skin condition questionnaire at screening
- •Agreed to avoid prolonged exposure to UV radiation for the duration of the study
排除标准
- •Women who were pregnant, breastfeeding, or planning to become pregnant during the trial
- •Acute or chronic skin disease (i.e. atopic dermatitis, eczema, rosacea, psoriasis) or dermatological disorders (scars, sunburns, moles) near the test sites
- •Topical medications used near the test area within 6 weeks prior to baseline
- •Use of tretinoin, adapalene, tazarotene or other topical medications for the treatment of skin aging near the test site during the 12 weeks preceding baseline
- •Application of topical alpha hydroxyl acids near the test site within 28 days of baseline
- •Use of, or planning to use, systemic corticosteroids within 28 days of baseline or during the study
- •Use of natural health supplements for improving the skin (specifically high concentrations of vitamin A, to be assessed on an individual basis)
- •Planned or unavoidable exposure to intense ultraviolet (UV) radiation during the study (such as sun tanning salons, vacations in a sunny climate or outdoor worker)
- •Botulinum toxin A (Botox) injection treatment near the test sites within 2 years of baseline or plan to receive this treatment during the study
- •Filler injection (collagen, hyaluronic acid, etc.) near the test sites within 2 years of baseline or plan to receive this treatment during the study
- •Tattoos on or near the test area
- •Unstable medical conditions
- •Consumption of more than 2 alcoholic drinks /day
- •Alcohol or drug abuse within 6 months of baseline
- •Tobacco use within 1 year of baseline
- •Use of medical marijuana
- •Participation in clinical research trial within 30 days prior to randomization
- •Allergy or sensitivity to study ingredients or who do not consume fish products (i.e. vegetarians)
- •Participants who were on a low protein diet
- •Cognitively impaired and/or unable to give informed consent
- •Any other condition which in the Investigator's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual (e.g. cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
结局指标
主要结局
Cheek skin elasticity
时间窗: 12 weeks from baseline
Cheek skin elasticity will be measured using the Cutometer® (MPA 580), which applies the suction method of negative pressure. The skin is drawn into the aperture of the probe using negative pressure, and after a defined time, is released again. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) are displayed as curves (penetration depth in mm/time) in real time during the analysis.The difference in cheek skin elasticity, measured as Gross skin elasticity (R2), between Vinh Wellness Collagen and placebo supplemented participants after 12 weeks. Cheek skin elasticity will be on a scale of 0-100; 0= no improvement, 100 = great improvement.
次要结局
- Cheek Skin hydration(12 weeks from baseline)
- Net Skin elasticity(Baseline, week 6 and week 12.)
- Viscoelastic recovery (overall elasticity)(12 weeks from baseliine)
- Body mass index (BMI)(Baseline, week 6 and week 12.)
- Biological elasticity(Baseline, week 6 and week 12.)
- Systolic and diastolic blood pressure(Baseline, week 6 and week 12.)
- Body weight(Baseline, week 6 and week 12.)
- Complete blood count (CBC)(Baseline, week 6 and week 12.)
- Underarm skin elasticity(12 weeks from baseline)
- Heart rate(Baseline, week 6 and week 12.)
- Sodium ion(Baseline, week 6 and week 12.)
- Creatinine(Baseline, week 6 and week 12.)
- Nasolabial wrinkles(12 weeks from baseliine)
- Skin quality using visual analogue scale (VAS) scores(12 weeks from baseliine)
- Aspartate transaminase (AST)(Baseline, week 6 and week 12.)
- Bilirubin(Baseline, week 6 and week 12.)
- Alanine transaminase (ALT)(Baseline, week 6 and week 12.)
- Potassium ion(Baseline, week 6 and week 12.)
- Chloride ion(Baseline, week 6 and week 12.)
- eGFR(Baseline, week 6 and week 12.)