Sleep QualityTECOSNCT07461402
Plant Protein With Ashwagandha-Rhodiola for Sleep Quality
A study testing Plant Protein Supplement, Rhodiola rosea Extract and Ashwagandha KSM-66 in people with Sleep Quality and Sleep Disorders, run by Universidad Pablo de Olavide at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Sleep Quality, Sleep Disorders, Insomnia
- What is being tested?
- Plant Protein Supplement, Rhodiola rosea Extract and Ashwagandha KSM-66
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2025to 4 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects on Sleep Quality and Bioelectrical Parameters of Cellular Health After Administration of a Plant Protein Supplement Combined With Ashwagandha and Rhodiola
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.
Read more
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.
Read the detailed description
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.
STUDY DESIGN
This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial conducted at three sites in Spain (Pozoblanco, Seville, and Yecla). The study was approved by the Research Ethics Committee of the Virgen Macarena and Virgen del Rocío University Hospitals (Code: 2061-N-21) on June 21, 2021, and is conducted in accordance with the Declaration of Helsinki.
PARTICIPANTS
One hundred adults aged 35-70 years with sleep disturbances will be recruited and randomized 1:1 to intervention (VERUM, n=50) or placebo (PLACEBO, n=50) groups. Key inclusion criteria include experiencing sleep disturbances, willingness to consume the plant protein supplement, and ability to provide informed consent. Exclusion criteria include known allergies to study ingredients, current use of sleep medications, serious medical conditions, and pregnancy or lactation.
INTERVENTION
VERUM Group: Participants will receive plant protein powder (27 g/day containing pea, rice, and hemp protein isolate) plus two tablets daily containing Rhodiola rosea (300 mg) and Withania somnifera KSM-66® (500 mg) for 30 consecutive days.
PLACEBO Group: Participants will receive maltodextrin powder (matched for appearance and taste) plus placebo capsules (identical in appearance) for 30 consecutive days.
All participants and investigators will be blinded to group assignment throughout the study period.
OUTCOME MEASURES
Primary Outcome: Sleep quality will be assessed using the validated Sleep Quality Questionnaire (SQQ), completed daily by participants. The SQQ evaluates three domains:
- Sleep Difficulty subscale (range 0-16)
- Daytime Sleepiness subscale (range 0-24)
- Total Sleep Score (range 0-40)
Higher scores indicate worse sleep quality.
Secondary Outcome: Phase angle, a bioelectrical parameter reflecting cellular health and membrane integrity, will be measured using bioimpedance analysis (BIA-TELELAB) at baseline (Day 0) and end of intervention (Day 30).
STATISTICAL ANALYSIS
Sleep quality data will be analyzed using longitudinal mixed models to account for repeated daily measurements. Phase angle will be analyzed using non-parametric tests. Effect sizes will be calculated using Cohen's d. The significance level will be set at α = 0.05. Analysis will include all participants who complete outcome assessments.
PROPOSED MECHANISMS
The proposed mechanisms of action include: (1) tryptophan provision for serotonin/melatonin synthesis, (2) HPA axis modulation and cortisol reduction, (3) GABAergic effects, (4) nocturnal glycemic stabilization, and (5) enhanced stress resilience through adaptogenic pathways.
SAMPLE SIZE JUSTIFICATION
A sample size of 100 participants (50 per group) was determined to provide adequate statistical power to detect clinically meaningful differences in sleep quality measures between groups, accounting for an estimated dropout rate of 20-30%.
SAFETY MONITORING
Participants will be monitored for adverse events throughout the study. Any adverse events will be recorded and reported according to institutional and regulatory requirements.
- Conditions
- Sleep Quality, Sleep Disorders, Insomnia
- Being tested
- Plant Protein Supplement, Rhodiola rosea Extract, Ashwagandha KSM-66, Placebo
- Keywords
- Rhodiola rosea, Adaptogens, Ashwagandha, Plant protein, Sleep quality, Nutritional intervention, Bioimpedance, Stress management
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant Protein SupplementDietary supplement
Also called Pea Protein Isolate, Rice Protein Isolate, Hemp Protein Isolate
Plant-based protein powder supplement containing 27 grams per day of a proprietary blend of three protein sources: pea protein isolate, rice protein isolate, and hemp protein isolate. The powder is mixed with water or beverage of choice and consumed once daily for 30 consecutive days. This protein blend provides essential and branched-chain amino acids, including tryptophan (precursor to serotonin and melatonin), which may influence sleep quality through neurotransmitter synthesis and nocturnal glycemic stabilization.
Rhodiola rosea ExtractDietary supplement
Also called Rhodiola, Golden Root, Arctic Root
Rhodiola rosea extract supplement in tablet form containing 300 milligrams per day. One or two tablets taken daily with meals for 30 consecutive days. Rhodiola rosea is an adaptogenic herb that helps the body manage stress through modulation of the hypothalamic-pituitary-adrenal (HPA) axis. It enhances stress resilience and has neuroprotective effects. May synergistically improve sleep quality when combined with other adaptogens and protein supplementation.
Ashwagandha KSM-66Dietary supplement
Also called Withania somnifera, KSM-66 Ashwagandha, Indian Ginseng
Withania somnifera (Ashwagandha) KSM-66® extract supplement in tablet form containing 500 milligrams per day. One or two tablets taken daily with meals for 30 consecutive days. Ashwagandha is an adaptogenic herb that modulates the hypothalamic-pituitary-adrenal (HPA) axis, reduces cortisol levels, and has gamma-aminobutyric acid (GABA) receptor effects. Extensively studied for improving sleep quality, reducing sleep latency, and decreasing nighttime awakenings.
PlaceboDietary supplement
Also called Placebo Comparator, Maltodextrin
Placebo intervention consisting of two components: (1) Maltodextrin powder matched to the active protein powder in appearance, taste, texture, color, and packaging, mixed with water or beverage, consumed once daily; and (2) Inert placebo capsules identical in appearance, size, color, shape, and packaging to the active adaptogen tablets, taken with meals. All placebo products contain no active ingredients and are consumed for 30 consecutive days. Participants, care providers, investigators, and outcomes assessors are blinded to treatment assignment.
| Study group | Role | What they receive |
|---|---|---|
| VERUM: Plant Protein + Ashwagandha + Rhodiola | Experimental | 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. Receives: Dietary Supplement: Plant Protein Supplement; Dietary Supplement: Rhodiola rosea Extract; Dietary Supplement: Ashwagandha KSM-66 |
| PLACEBO: Maltodextrin + Placebo Capsules | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality assessed by Sleep Quality Questionnaire (SQQ)
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:
- Sleep Difficulty subscale (range: 0-16 points)
- Daytime Sleepiness subscale (range: 0-24 points)
- 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.
Measured: Daily assessments throughout the 30-day intervention period (Day 1 to Day 30)
Secondary outcomes (1)
Phase Angle measured by Bioimpedance Analysis (BIA)
Phase angle is a bioelectrical parameter that reflects cellular health and membrane integrity, measured using bioelectrical impedance analysis (BIA) with the BIA-TELELAB device.
Phase angle is derived from the relationship between resistance and reactance of body tissues to an electrical current. It is expressed in degrees (°). Higher phase angle values generally indicate better cellular health, membrane integrity, and body cell mass. Lower values may indicate cellular dysfunction or compromised health status.
The measurement will be performed under standardized conditions (fasting, hydration controlled, supine position).
Measured: Baseline (Day 0) and End of Intervention (Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Nov 2025
- Primary completion2 Dec 2025
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pablo de Olavide
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Responsible party
- Principal investigator, Antonio Molina Lopez, Universidad Pablo de Olavide
- Investigators
- Francisco José Berral-de la Rosa, Principal investigator, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461402
- Sponsor's protocol ID
- Universidad Pablo de Olavide
- Other IDs
- 2061-N-21
- Acronym
- TECOS
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article will be available upon reasonable request to qualified researchers for meta-analyses or other legitimate research purposes. Data will be shared after de-identification to protect participant privacy.
Publications
Molina-López A, Leo-Romero A, Molina-López M, Polo-Marco S, Domínguez-Balmaseda D, García-Pérez-de-Sevilla G, Casanova E, Moya-Amaya H, Granizo Bermejo D, Berral-de la Rosa FJ. Effects on Sleep Quality and Bioelectrical Parameters of Cellular Health After Administration of a Plant Protein Supplement Combined with Ashwagandha and Rhodiola: A Randomized, Double-Blind, Placebo-Controlled Trial. Manuscript in preparation. 2026.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Sleep Quality and Bioelectrical Parameters of Cellular Health After Administration of a Plant Protein Supplement Combined With Ashwagandha and Rhodiola
- ClinicalTrials.gov ID
- NCT07461402
- Acronym / sponsor ID
- TECOS / Universidad Pablo de Olavide
- Conditions
- Sleep Quality, Sleep Disorders, Insomnia
- Keywords
- Rhodiola rosea, Adaptogens, Ashwagandha, Plant protein, Sleep quality, Nutritional intervention, Bioimpedance, Stress management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Pablo de OlavideUniversity, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
STUDY DESIGN
This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial conducted at three sites in Spain (Pozoblanco, Seville, and Yecla). The study was approved by the Research Ethics Committee of the Virgen Macarena and Virgen del Rocío University Hospitals (Code: 2061-N-21) on June 21, 2021, and is conducted in accordance with the Declaration of Helsinki.
PARTICIPANTS
One hundred adults aged 35-70 years with sleep disturbances will be recruited and randomized 1:1 to intervention (VERUM, n=50) or placebo (PLACEBO, n=50) groups. Key inclusion criteria include experiencing sleep disturbances, willingness to consume the plant protein supplement, and ability to provide informed consent. Exclusion criteria include known allergies to study ingredients, current use of sleep medications, serious medical conditions, and pregnancy or lactation.
INTERVENTION
VERUM Group: Participants will receive plant protein powder (27 g/day containing pea, rice, and hemp protein isolate) plus two tablets daily containing Rhodiola rosea (300 mg) and Withania somnifera KSM-66® (500 mg) for 30 consecutive days.
PLACEBO Group: Participants will receive maltodextrin powder (matched for appearance and taste) plus placebo capsules (identical in appearance) for 30 consecutive days.
All participants and investigators will be blinded to group assignment throughout the study period.
OUTCOME MEASURES
Primary Outcome: Sleep quality will be assessed using the validated Sleep Quality Questionnaire (SQQ), completed daily by participants. The SQQ evaluates three domains:
- Sleep Difficulty subscale (range 0-16)
- Daytime Sleepiness subscale (range 0-24)
- Total Sleep Score (range 0-40)
Higher scores indicate worse sleep quality.
Secondary Outcome: Phase angle, a bioelectrical parameter reflecting cellular health and membrane integrity, will be measured using bioimpedance analysis (BIA-TELELAB) at baseline (Day 0) and end of intervention (Day 30).
STATISTICAL ANALYSIS
Sleep quality data will be analyzed using longitudinal mixed models to account for repeated daily measurements. Phase angle will be analyzed using non-parametric tests. Effect sizes will be calculated using Cohen's d. The significance level will be set at α = 0.05. Analysis will include all participants who complete outcome assessments.
PROPOSED MECHANISMS
The proposed mechanisms of action include: (1) tryptophan provision for serotonin/melatonin synthesis, (2) HPA axis modulation and cortisol reduction, (3) GABAergic effects, (4) nocturnal glycemic stabilization, and (5) enhanced stress resilience through adaptogenic pathways.
SAMPLE SIZE JUSTIFICATION
A sample size of 100 participants (50 per group) was determined to provide adequate statistical power to detect clinically meaningful differences in sleep quality measures between groups, accounting for an estimated dropout rate of 20-30%.
SAFETY MONITORING
Participants will be monitored for adverse events throughout the study. Any adverse events will be recorded and reported according to institutional and regulatory requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VERUM: Plant Protein + Ashwagandha + Rhodiola | Experimental | Dietary Supplement: Plant Protein Supplement, Dietary Supplement: Rhodiola rosea Extract, Dietary Supplement: Ashwagandha KSM-66Participants 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. |
| PLACEBO: Maltodextrin + Placebo Capsules | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant Protein SupplementAlso: Pea Protein Isolate, Rice Protein Isolate, Hemp Protein IsolatePlant-based protein powder supplement containing 27 grams per day of a proprietary blend of three protein sources: pea protein isolate, rice protein isolate, and hemp protein isolate. The powder is mixed with water or beverage of choice and consumed once daily for 30 consecutive days. This protein blend provides essential and branched-chain amino acids, including tryptophan (precursor to serotonin and melatonin), which may influence sleep quality through neurotransmitter synthesis and nocturnal glycemic stabilization. | Dietary supplement | VERUM: Plant Protein + Ashwagandha + Rhodiola |
| Rhodiola rosea ExtractAlso: Rhodiola, Golden Root, Arctic RootRhodiola rosea extract supplement in tablet form containing 300 milligrams per day. One or two tablets taken daily with meals for 30 consecutive days. Rhodiola rosea is an adaptogenic herb that helps the body manage stress through modulation of the hypothalamic-pituitary-adrenal (HPA) axis. It enhances stress resilience and has neuroprotective effects. May synergistically improve sleep quality when combined with other adaptogens and protein supplementation. | Dietary supplement | VERUM: Plant Protein + Ashwagandha + Rhodiola |
| Ashwagandha KSM-66Also: Withania somnifera, KSM-66 Ashwagandha, Indian GinsengWithania somnifera (Ashwagandha) KSM-66® extract supplement in tablet form containing 500 milligrams per day. One or two tablets taken daily with meals for 30 consecutive days. Ashwagandha is an adaptogenic herb that modulates the hypothalamic-pituitary-adrenal (HPA) axis, reduces cortisol levels, and has gamma-aminobutyric acid (GABA) receptor effects. Extensively studied for improving sleep quality, reducing sleep latency, and decreasing nighttime awakenings. | Dietary supplement | VERUM: Plant Protein + Ashwagandha + Rhodiola |
| PlaceboAlso: Placebo Comparator, MaltodextrinPlacebo intervention consisting of two components: (1) Maltodextrin powder matched to the active protein powder in appearance, taste, texture, color, and packaging, mixed with water or beverage, consumed once daily; and (2) Inert placebo capsules identical in appearance, size, color, shape, and packaging to the active adaptogen tablets, taken with meals. All placebo products contain no active ingredients and are consumed for 30 consecutive days. Participants, care providers, investigators, and outcomes assessors are blinded to treatment assignment. | Dietary supplement | PLACEBO: Maltodextrin + Placebo Capsules |
Primary outcome
Sleep Quality assessed by Sleep Quality Questionnaire (SQQ)
Time frame: 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.
1 secondary outcome
Phase Angle measured by Bioimpedance Analysis (BIA)
Time frame: Baseline (Day 0) and End of Intervention (Day 30)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Results publicationMolina-López A, Leo-Romero A, Molina-López M, Polo-Marco S, Domínguez-Balmaseda D, García-Pérez-de-Sevilla G, Casanova E, Moya-Amaya H, Granizo Bermejo D, Berral-de la Rosa FJ. Effects on Sleep Quality and Bioelectrical Parameters of Cellular Health After Administration of a Plant Protein Supplement Combined with Ashwagandha and Rhodiola: A Randomized, Double-Blind, Placebo-Controlled Trial. Manuscript in preparation. 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article will be available upon reasonable request to qualified researchers for meta-analyses or other legitimate research purposes. Data will be shared after de-identification to protect participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco José Berral-de la Rosa principal investigator
PhD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant Protein Supplement, Rhodiola rosea Extract and Ashwagandha KSM-66 in people with Sleep Quality and Sleep Disorders, run by Universidad Pablo de Olavide at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality assessed by Sleep Quality Questionnaire (SQQ) (time frame: Daily assessments throughout the 30-day intervention period (Day 1 to Day 30)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07461402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.