Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:26 PM
Study NCT ID:
NCT07461402
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plant Protein With Ashwagandha-Rhodiola for Sleep Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030693', 'term': 'Ashwagandha'}, {'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Quality assessed by Sleep Quality Questionnaire (SQQ)', 'timeFrame': 'Daily assessments throughout the 30-day intervention period (Day 1 to Day 30)', 'description': '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:\n\n1. Sleep Difficulty subscale (range: 0-16 points)\n2. Daytime Sleepiness subscale (range: 0-24 points)\n3. Total Sleep Score (range: 0-40 points)\n\nHigher 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.'}], 'secondaryOutcomes': [{'measure': 'Phase Angle measured by Bioimpedance Analysis (BIA)', 'timeFrame': 'Baseline (Day 0) and End of Intervention (Day 30)', 'description': 'Phase angle is a bioelectrical parameter that reflects cellular health and membrane integrity, measured using bioelectrical impedance analysis (BIA) with the BIA-TELELAB device.\n\nPhase 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.\n\nThe measurement will be performed under standardized conditions (fasting, hydration controlled, supine position).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rhodiola rosea', 'Adaptogens', 'Ashwagandha', 'Plant protein', 'Sleep quality', 'Nutritional intervention', 'Bioimpedance', 'Stress management'], 'conditions': ['Sleep Quality', 'Sleep Disorders', 'Insomnia']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nOne 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.\n\nSleep 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.\n\nThe 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.', 'detailedDescription': "BACKGROUND AND RATIONALE\n\nSleep 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.\n\nNatural 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.\n\nAdaptogens 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.\n\nThis 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.\n\nSTUDY DESIGN\n\nThis 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.\n\nPARTICIPANTS\n\nOne 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.\n\nINTERVENTION\n\nVERUM 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.\n\nPLACEBO Group: Participants will receive maltodextrin powder (matched for appearance and taste) plus placebo capsules (identical in appearance) for 30 consecutive days.\n\nAll participants and investigators will be blinded to group assignment throughout the study period.\n\nOUTCOME MEASURES\n\nPrimary Outcome: Sleep quality will be assessed using the validated Sleep Quality Questionnaire (SQQ), completed daily by participants. The SQQ evaluates three domains:\n\n* Sleep Difficulty subscale (range 0-16)\n* Daytime Sleepiness subscale (range 0-24)\n* Total Sleep Score (range 0-40)\n\nHigher scores indicate worse sleep quality.\n\nSecondary 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).\n\nSTATISTICAL ANALYSIS\n\nSleep 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.\n\nPROPOSED MECHANISMS\n\nThe 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.\n\nSAMPLE SIZE JUSTIFICATION\n\nA 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%.\n\nSAFETY MONITORING\n\nParticipants will be monitored for adverse events throughout the study. Any adverse events will be recorded and reported according to institutional and regulatory requirements."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 35 to 70 years (inclusive)\n* Experiencing sleep disturbances or sleep quality problems\n* Willing and able to consume plant protein supplement daily for 30 days\n* Willing and able to take adaptogen tablets daily for 30 days\n* Able to provide written informed consent\n* Able to complete daily sleep quality questionnaires\n* Available for baseline and follow-up assessments\n* Willing to maintain regular lifestyle habits during the study period\n\nExclusion Criteria:\n\n* Age less than 35 years or greater than 70 years\n* Known allergies or hypersensitivity to any study ingredients (pea protein, rice protein, hemp protein, Rhodiola rosea, Withania somnifera/ashwagandha, or excipients)\n* Current use of prescription sleep medications or hypnotics\n* Current use of other herbal supplements for sleep (washout period may be allowed)\n* Serious or unstable medical conditions that could interfere with study participation or safety\n* Severe psychiatric disorders requiring medication\n* Uncontrolled metabolic diseases (for example, uncontrolled diabetes, thyroid disorders)\n* Pregnancy or lactation\n* Planning to become pregnant during the study period\n* Participation in another clinical trial within the past 30 days\n* Inability to understand or comply with study procedures\n* Shift workers or individuals with irregular sleep schedules\n* Recent major life events significantly affecting sleep patterns'}, 'identificationModule': {'nctId': 'NCT07461402', 'acronym': 'TECOS', 'briefTitle': 'Plant Protein With Ashwagandha-Rhodiola for Sleep Quality', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Pablo de Olavide'}, 'officialTitle': 'Effects on Sleep Quality and Bioelectrical Parameters of Cellular Health After Administration of a Plant Protein Supplement Combined With Ashwagandha and Rhodiola', 'orgStudyIdInfo': {'id': 'Universidad Pablo de Olavide'}, 'secondaryIdInfos': [{'id': '2061-N-21', 'type': 'REGISTRY', 'domain': 'Research Ethics Committee - Virgen Macarena and Virgen del Rocío University Hospitals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VERUM: Plant Protein + Ashwagandha + Rhodiola', 'description': '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.', 'interventionNames': ['Dietary Supplement: Plant Protein Supplement', 'Dietary Supplement: Rhodiola rosea Extract', 'Dietary Supplement: Ashwagandha KSM-66']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO: Maltodextrin + Placebo Capsules', 'description': '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.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Plant Protein Supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Pea Protein Isolate', 'Rice Protein Isolate', 'Hemp Protein Isolate'], 'description': '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.', 'armGroupLabels': ['VERUM: Plant Protein + Ashwagandha + Rhodiola']}, {'name': 'Rhodiola rosea Extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Rhodiola', 'Golden Root', 'Arctic Root'], 'description': '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.', 'armGroupLabels': ['VERUM: Plant Protein + Ashwagandha + Rhodiola']}, {'name': 'Ashwagandha KSM-66', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Withania somnifera', 'KSM-66 Ashwagandha', 'Indian Ginseng'], 'description': '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.', 'armGroupLabels': ['VERUM: Plant Protein + Ashwagandha + Rhodiola']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo Comparator', 'Maltodextrin'], 'description': '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.', 'armGroupLabels': ['PLACEBO: Maltodextrin + Placebo Capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14400', 'city': 'Seville', 'state': 'Cordoba', 'country': 'Spain', 'facility': 'Farmacia Molina', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Francisco José Berral-de la Rosa', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PhD'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Individual participant data (IPD) will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication. Requests received after this period will be considered on a case-by-case basis depending on data storage and accessibility at that time.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'IPD will be shared with qualified researchers who provide a methodologically sound proposal for legitimate research purposes, including meta-analyses, systematic reviews, or secondary analyses. Requestors must:\n\n1. Submit a detailed research proposal describing the aims, methods, and planned analyses\n2. Demonstrate appropriate ethical approval from their institution (if required)\n3. Sign a data access agreement committing to:\n\n * Use data only for approved research purposes\n * Maintain participant confidentiality\n * Acknowledge the original study in any publications\n * Not attempt to re-identify participants\n\nRequests should be directed to the corresponding author at fjberde@upo.es (Dr. Francisco José Berral-de la Rosa, Universidad Pablo de Olavide, Seville, Spain). Proposals will be reviewed within 30 days. Approved requestors will receive de-identified IPD in a secure format.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Pablo de Olavide', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator, PhD, CTS-595 Research Group, Centre for Research into Physical and Sporting Performance', 'investigatorFullName': 'Antonio Molina Lopez', 'investigatorAffiliation': 'Universidad Pablo de Olavide'}}}}