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Whey Protein and Adaptogenic Supplementation in Physically Active Females

2026年6月3日 更新者：Olivia Charlotte Coope、Sports Performance and Applied Research in Trials and Analysis

Whey Protein and Adaptogenic Herb Supplementation in Physically Active Females: A Randomised Controlled Trial

The goal of this clinical trial is to learn whether whey protein or plant protein supplements, with or without an adaptogenic herb blend, can improve strength, recovery, stress, and wellbeing in active females. The adaptogenic blend contains ashwagandha root extract and shatavari root extract.

The main questions the study aims to answer are:

  • Do whey protein and plant protein supplements improve muscle strength and recovery in physically active females?
  • Does adding ashwagandha and shatavari improve stress, recovery, sleep, and wellbeing compared with protein alone?
  • Are there differences between whey protein and plant protein when combined with the adaptogenic blend?

Researchers will compare four supplement groups:

  • Whey protein
  • Whey protein with ashwagandha and shatavari
  • Plant protein
  • Plant protein with ashwagandha and shatavari

Participants will:

  • Take their assigned supplement daily for 6 weeks
  • Attend testing sessions before and after the intervention
  • Complete questionnaires about recovery, sleep, stress, soreness, and digestive health
  • Provide saliva samples to measure stress, hormone, immune, and inflammation markers
  • Complete muscle strength tests, including handgrip strength and push-up testing
  • Complete a 24-hour dietary recall. The study includes physically active females aged 18 to 45 years who regularly participate in structured training.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イギリス
    • East Sussex
      • Brighton、East Sussex、イギリス
        • 募集
        • Strength and Nutrition Ltd
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  • Female, aged 18-45 years
  • Currently participating in regular structured athletic or physical training (≥3 sessions per week)
  • Free from musculoskeletal injury that would prevent testing
  • Willing to maintain usual diet and training habits during the study
  • Not currently using protein supplements or adaptogenic supplements

Exclusion Criteria:

  • Pregnant, breastfeeding, or planning pregnancy during the study period
  • Known allergy or sensitivity to dairy, pea protein, pumpkin seed, chia seed, ashwagandha, shatavari, or nightshades
  • Current use of prescribed medication that may interact with the supplements
  • Thyroid disorders, autoimmune conditions, hormone-sensitive conditions, or other medical conditions that may be affected by supplementation
  • Diagnosed eating disorder or condition affecting protein metabolism
  • Current musculoskeletal injury preventing participation in testing
  • Current use of other protein supplements or adaptogens

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Whey Protein + Adaptogenic Blend
Participants will consume a whey protein supplement containing ashwagandha KSM-66® (250 mg) and shatavari SRI-81™ (300 mg) daily for 6 weeks. Assessments will be conducted at baseline and post-intervention.
ダイエットサプリメント：Whey Protein With Adaptogenic Blend
Participants will consume a whey protein supplement containing ashwagandha KSM-66® root extract (250 mg) and shatavari SRI-81™ root extract (300 mg) daily for 6 weeks. Supplements will be provided in identical blank tubs. Participants will maintain usual diet and training habits during the study.
他の名前：
  • Ashwagandha and Shatavari Whey Protein
  • Whey Protein Plus Adaptogens
実験的：Plant Protein + Adaptogenic Blend
Participants will consume a plant-based protein supplement containing ashwagandha KSM-66® (250 mg) and shatavari SRI-81™ (300 mg) daily for 6 weeks. Assessments will be conducted at baseline and post-intervention.
ダイエットサプリメント：Plant Protein With Adaptogenic Blend
Participants will consume a plant-based protein supplement containing ashwagandha KSM-66® root extract (250 mg) and shatavari SRI-81™ root extract (300 mg) daily for 6 weeks. Supplements will be provided in identical blank tubs. Participants will maintain usual diet and training habits during the study.
他の名前：
  • Plant Protein Plus Adaptogens
  • Ashwagandha and Shatavari Plant Protein
アクティブコンパレータ：Whey protein
Participants will consume a whey protein supplement daily for 6 weeks. Assessments of muscle strength, recovery, stress, wellbeing, dietary intake, and salivary biomarkers will be conducted at baseline and post-intervention.
ダイエットサプリメント：Whey protein
Participants will consume a whey protein supplement daily for 6 weeks. The supplement will be provided in identical blank tubs. Participants will be instructed to maintain their usual diet and training habits throughout the intervention period.
他の名前：
  • Grass-Fed Whey Protein
  • Whey Protein Powder
アクティブコンパレータ：Plant protein
Participants will consume a plant-based protein supplement daily for 6 weeks. Assessments of muscle strength, recovery, stress, wellbeing, dietary intake, and salivary biomarkers will be conducted at baseline and post-intervention.
ダイエットサプリメント：Plant Protein Supplement
Participants will consume a plant-based protein supplement daily for 6 weeks. The supplement will be provided in identical blank tubs. Participants will be instructed to maintain their usual diet and training habits throughout the intervention period.
他の名前：
  • Plant-Based Protein
  • Vegan Protein Supplement

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Salivary Cortisol Concentration
時間枠：Baseline and Week 6
Change in salivary cortisol concentration from baseline to post-intervention following 6 weeks of whey protein or plant protein supplementation with or without an adaptogenic herb blend containing ashwagandha KSM-66® and shatavari SRI-81™. Results will be reported in ng/mL.
Baseline and Week 6

二次結果の測定

結果測定
メジャーの説明
時間枠
Handgrip Strength
時間枠：Baseline and Week 6
Change in maximal handgrip strength measured using a CAMRY dynamometer from baseline to post-intervention.
Baseline and Week 6
Upper Body Muscular Endurance
時間枠：Baseline and Week 6
Change in upper body muscular endurance assessed using the 90-degree push-up test protocol from baseline to post-intervention.
Baseline and Week 6
Perceived Gastrointestinal Health
時間枠：Baseline and Week 6
Change in gastrointestinal symptoms and digestive comfort assessed using a gastrointestinal distress questionnaire.
Baseline and Week 6
Dietary Intake
時間枠：Baseline and Week 6
Dietary intake assessed using a 24-hour dietary recall to evaluate habitual nutritional intake during the study period.
Baseline and Week 6
Perceived Recovery and Wellbeing
時間枠：Baseline and Week 6
Participants will complete the Hooper Index Questionnaire, which assesses four domains: sleep quality, fatigue, stress, and muscle soreness. Each domain is rated on a 10-point Likert scale ranging from 1 to 10, with total scores ranging from 4 to 40. Higher scores indicate poorer wellbeing and recovery status, whereas lower scores indicate better perceived wellbeing and recovery.
Baseline and Week 6
Salivary DHEA-S Concentration
時間枠：Baseline and Week 6
Salivary DHEA-S concentration will be measured from saliva samples using enzyme-linked immunosorbent assay (ELISA) techniques. Results will be reported in ng/mL.
Baseline and Week 6
Salivary Oestradiol Concentration
時間枠：Baseline and Week 6
Salivary oestradiol concentration will be measured from saliva samples using ELISA. Results will be reported in pg/mL.
Baseline and Week 6
Salivary Secretory Immunoglobulin A (sIgA) Concentration
時間枠：Baseline and Week 6
Salivary secretory immunoglobulin A (sIgA) concentration will be measured from saliva samples using ELISA. Results will be reported in µg/mL.
Baseline and Week 6
Salivary C-reactive Protein Concentration
時間枠：Baseline to Week 6
Salivary C-reactive protein will be measured from saliva samples using ELISA. Results will be reported in pg/mL.
Baseline to Week 6

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Sports Performance and Applied Research in Trials and Analysis

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2026年8月12日

研究の完了 (推定)

2026年9月20日

試験登録日

最初に提出

2026年5月12日

QC基準を満たした最初の提出物

2026年5月12日

最初の投稿 (実際)

2026年5月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月5日

QC基準を満たした最後の更新が送信されました

2026年6月3日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • ASH-WHEY-001

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data (IPD) will not be shared with other researchers. Data collected in this study will be anonymised and retained only for the duration of analysis before permanent deletion, in accordance with the study protocol, participant consent, and UK GDPR requirements.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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