Effects on Sleep Quality and Bioelectrical Parameters of Cellular Health After Administration of a Plant Protein Supplement Combined With Ashwagandha and Rhodiola
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sleep Quality assessed by Sleep Quality Questionnaire (SQQ)
研究概览
简要总结
This study evaluates whether a combination of plant protein with adaptogenic herbs (ashwagandha and rhodiola) can improve sleep quality in middle-aged adults with sleep disturbances.
One hundred participants aged 35-70 years with sleep problems will be randomly assigned to receive either the active intervention or placebo for 30 days. The active group will receive 27 grams per day of plant protein (pea, rice, and hemp isolate) combined with 300 mg of Rhodiola rosea and 500 mg of Withania somnifera (ashwagandha KSM-66®) in tablet form. The placebo group will receive maltodextrin and placebo capsules that look identical.
Sleep quality will be measured daily using a validated Sleep Quality Questionnaire (SQQ) that assesses difficulty falling asleep, daytime sleepiness, and overall sleep quality. Body composition and cellular health will also be measured using bioimpedance analysis at the beginning and end of the study.
The primary hypothesis is that the combination of plant protein with ashwagandha and rhodiola will produce greater improvements in sleep quality compared to placebo. The study will also evaluate the safety and tolerability of this nutritional intervention.
详细描述
BACKGROUND AND RATIONALE
Sleep disturbances affect 30-40% of the adult population worldwide and are associated with serious health consequences including insulin resistance, weight gain, and increased cardiovascular risk. While pharmaceutical sleep medications (benzodiazepines and hypnotics) are commonly prescribed, they have significant limitations including potential for addiction, adverse side effects, and disruption of natural sleep architecture.
Natural alternatives are increasingly sought. Protein supplementation may influence sleep through multiple mechanisms: proteins provide tryptophan (a precursor to serotonin and melatonin), help stabilize nocturnal blood glucose levels, and can generate bioactive peptides with sedative properties. However, studies on protein and sleep have shown mixed results.
Adaptogens are medicinal plants that help the body adapt to stress. Ashwagandha (Withania somnifera) has been extensively studied and shown to improve sleep quality, reduce sleep latency, and decrease nighttime awakenings, likely through modulation of the hypothalamic-pituitary-adrenal (HPA) axis and GABAergic effects. Rhodiola rosea, another well-characterized adaptogen, has demonstrated stress-resilience enhancement and neuroprotective effects.
This study is the first to investigate the combined effects of plant protein with both ashwagandha and rhodiola on sleep quality, hypothesizing a synergistic multimodal effect.
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)
盲法说明
Participants were randomly assigned to one of two parallel groups (VERUM or PLACEBO) for the entire 30-day intervention period. No crossover or sequential assignment was used.
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 35 to 70 years (inclusive)
- •Experiencing sleep disturbances or sleep quality problems
- •Willing and able to consume plant protein supplement daily for 30 days
- •Willing and able to take adaptogen tablets daily for 30 days
- •Able to provide written informed consent
- •Able to complete daily sleep quality questionnaires
- •Available for baseline and follow-up assessments
- •Willing to maintain regular lifestyle habits during the study period
排除标准
- •Age less than 35 years or greater than 70 years
- •Known allergies or hypersensitivity to any study ingredients (pea protein, rice protein, hemp protein, Rhodiola rosea, Withania somnifera/ashwagandha, or excipients)
- •Current use of prescription sleep medications or hypnotics
- •Current use of other herbal supplements for sleep (washout period may be allowed)
- •Serious or unstable medical conditions that could interfere with study participation or safety
- •Severe psychiatric disorders requiring medication
- •Uncontrolled metabolic diseases (for example, uncontrolled diabetes, thyroid disorders)
- •Pregnancy or lactation
- •Planning to become pregnant during the study period
- •Participation in another clinical trial within the past 30 days
- •Inability to understand or comply with study procedures
- •Shift workers or individuals with irregular sleep schedules
- •Recent major life events significantly affecting sleep patterns
研究组 & 干预措施
VERUM: Plant Protein + Ashwagandha + Rhodiola
Participants will receive the active intervention for 30 consecutive days: (1) Plant Protein Powder containing 27 grams daily of pea, rice, and hemp protein isolates, mixed with water or beverage, consumed once daily; (2) Rhodiola rosea extract tablets containing 300 milligrams daily; (3) Withania somnifera (Ashwagandha) KSM-66® tablets containing 500 milligrams daily. Tablets are taken with meals. The protein provides tryptophan for neurotransmitter synthesis. Adaptogens modulate stress response via hypothalamic-pituitary-adrenal (HPA) axis and have gamma-aminobutyric acid (GABA) receptor effects. All products administered under double-blind conditions.
干预措施: Plant Protein Supplement (Dietary Supplement)
VERUM: Plant Protein + Ashwagandha + Rhodiola
Participants will receive the active intervention for 30 consecutive days: (1) Plant Protein Powder containing 27 grams daily of pea, rice, and hemp protein isolates, mixed with water or beverage, consumed once daily; (2) Rhodiola rosea extract tablets containing 300 milligrams daily; (3) Withania somnifera (Ashwagandha) KSM-66® tablets containing 500 milligrams daily. Tablets are taken with meals. The protein provides tryptophan for neurotransmitter synthesis. Adaptogens modulate stress response via hypothalamic-pituitary-adrenal (HPA) axis and have gamma-aminobutyric acid (GABA) receptor effects. All products administered under double-blind conditions.
干预措施: Rhodiola rosea Extract (Dietary Supplement)
VERUM: Plant Protein + Ashwagandha + Rhodiola
Participants will receive the active intervention for 30 consecutive days: (1) Plant Protein Powder containing 27 grams daily of pea, rice, and hemp protein isolates, mixed with water or beverage, consumed once daily; (2) Rhodiola rosea extract tablets containing 300 milligrams daily; (3) Withania somnifera (Ashwagandha) KSM-66® tablets containing 500 milligrams daily. Tablets are taken with meals. The protein provides tryptophan for neurotransmitter synthesis. Adaptogens modulate stress response via hypothalamic-pituitary-adrenal (HPA) axis and have gamma-aminobutyric acid (GABA) receptor effects. All products administered under double-blind conditions.
干预措施: Ashwagandha KSM-66 (Dietary Supplement)
PLACEBO: Maltodextrin + Placebo Capsules
Participants will receive placebo products for 30 consecutive days: (1) Placebo Powder containing maltodextrin, matched to active protein powder in appearance, taste, texture, color, and packaging, mixed with water or beverage, consumed once daily; (2) Placebo Capsules containing inert excipients, identical in appearance, size, color, shape, and packaging to active adaptogen tablets, taken with meals. No active ingredients. All products administered under double-blind conditions. Participants, care providers, investigators, and outcomes assessors are blinded to treatment assignment. Placebo products are indistinguishable from active products.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Sleep Quality assessed by Sleep Quality Questionnaire (SQQ)
时间窗: Daily assessments throughout the 30-day intervention period (Day 1 to Day 30)
Sleep quality will be measured using the validated Sleep Quality Questionnaire (SQQ), a self-reported instrument completed daily by participants. The SQQ evaluates three domains: 1. Sleep Difficulty subscale (range: 0-16 points) 2. Daytime Sleepiness subscale (range: 0-24 points) 3. Total Sleep Score (range: 0-40 points) Higher scores indicate worse sleep quality. Lower scores indicate better sleep quality. The questionnaire assesses difficulty falling asleep, nighttime awakenings, sleep quality perception, and daytime functioning related to sleep.
次要结局
- Phase Angle measured by Bioimpedance Analysis (BIA)(Baseline (Day 0) and End of Intervention (Day 30))
研究者
Antonio Molina Lopez
Investigator, PhD, CTS-595 Research Group, Centre for Research into Physical and Sporting Performance
Universidad Pablo de Olavide