Plant Protein With Ashwagandha-Rhodiola for Sleep Quality

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

Interventions

DIETARY_SUPPLEMENT

Plant Protein 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.

DIETARY_SUPPLEMENT

Rhodiola rosea Extract

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.

DIETARY_SUPPLEMENT

Ashwagandha KSM-66

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.

DIETARY_SUPPLEMENT

Placebo

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.

Sponsors & Collaborators

• Universidad Europea de Madrid

  collaborator OTHER

• Universidad Pablo de Olavide

  lead OTHER

Principal Investigators

• Francisco José Berral-de la Rosa · PhD

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-01

Primary Completion

2025-12-02

Completion

2025-12-04

Countries

• Spain

Study Locations