Plant Protein With Ashwagandha-Rhodiola for Sleep Quality

NCT07461402 | Completed

• 2 other identifiers: Universidad Pablo de Olavide2061-N-21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep Quality; Sleep Disorders; Insomnia

Keywords

Rhodiola rosea; Adaptogens; Ashwagandha; Plant protein; Sleep quality; Nutritional intervention; Bioimpedance; Stress management

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  Daily assessments throughout the 30-day intervention period (Day 1 to Day 30)

Secondary Outcomes (1)

• Phase Angle measured by Bioimpedance Analysis (BIA)

  Baseline (Day 0) and End of Intervention (Day 30)

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Plant Protein Supplement DIETARY_SUPPLEMENT

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.

Also known as: Pea Protein Isolate, Rice Protein Isolate, Hemp Protein Isolate

VERUM: Plant Protein + Ashwagandha + Rhodiola

Rhodiola rosea Extract DIETARY_SUPPLEMENT

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.

Also known as: Rhodiola, Golden Root, Arctic Root

VERUM: Plant Protein + Ashwagandha + Rhodiola

Ashwagandha KSM-66 DIETARY_SUPPLEMENT

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.

Also known as: Withania somnifera, KSM-66 Ashwagandha, Indian Ginseng

VERUM: Plant Protein + Ashwagandha + Rhodiola

Placebo DIETARY_SUPPLEMENT

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.

Also known as: Placebo Comparator, Maltodextrin

PLACEBO: Maltodextrin + Placebo Capsules

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Pablo de Olavide: lead
• Universidad Europea de Madrid: collaborator

Study Sites (1)

Farmacia Molina

Seville, Cordoba, 14400, Spain

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Interventions

Ashwagandha; maltodextrin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisco José Berral-de la Rosa

  PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, PhD, CTS-595 Research Group, Centre for Research into Physical and Sporting Performance

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 10, 2026
• Study Start: November 1, 2025
• Primary Completion: December 2, 2025
• Study Completion: December 4, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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: 1. Submit a detailed research proposal describing the aims, methods, and planned analyses 2. Demonstrate appropriate ethical approval from their institution (if required) 3. Sign a data access agreement committing to: * Use data only for approved research purposes * Maintain participant confidentiality * Acknowledge the original study in any publications * Not attempt to re-identify participants Requests 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.

Locations

ES (1)