Plant Protein With Ashwagandha-Rhodiola for Sleep Quality
Plant Protein With Ashwagandha-Rhodiola for Sleep Quality
NCT ID: NCT07461402 Phase: NA Status: COMPLETED Enrollment: 100 Completion: 2025-12-04
Conditions
Sleep Quality, Sleep Disorders, Insomnia
Interventions
Plant Protein Supplement, Rhodiola rosea Extract, Ashwagandha KSM-66, Placebo
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.
Primary Outcome
Sleep Quality assessed by Sleep Quality Questionnaire (SQQ)