The Impact of Ashwagandha on Perceived Stress, Sleep and Food Cravings in College Students

NCT05430685 | Completed Phase 2

• 1 other identifier: 19-132
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to compare the impact of 700 mg daily ashwagandha (Withania Somnifera) in healthy college students on sleep, stress and food cravings to healthy college students taking placebo.

Conditions

Stress; Sleep; Craving; Well Being

Keywords

Ashwagandha

Outcome Measures

Primary Outcomes (3)

• Impact of ashwagandha on Sleep

  Restorative Sleep Questionnaire is a 9-item validated scale assessing feelings and experiences about the participant's sleep and their perception of daytime consequences associated with their sleep patterns. Scores range from 0-100 where higher scores indicate better quality sleep.

  Change of restorative sleep quality at 30 days

• Impact of ashwagandha on Perceived Stress

  Stress was assessed using the Perceived Stress Scale a 10-item validated questionnaire measuring the degree to which situations in participant's life were viewed as stressful. Questions addressed anxious thoughts, locus of control, and coping mechanisms. Scores range from 0-40 (higher scores indicate higher stress levels).

  Change of perceived stress at 30 days

• Impact of ashwagandha on Food Cravings

  Eating behavior was assessed using the Food Cravings Questionnaire, a 15-item validated instrument assessing food behavior and appetite using Likert-scales related to intentions for eating, perceived control, hunger cues, emotional states, and guilt associated with cravings. Scores range between 15 and 90 (higher scores indicate more frequent and intense food cravings).

  Change of food cravings at 30 days

Secondary Outcomes (2)

• Qualitative analysis of ashwagandha on college students across sleep, stress and food cravings.

  At 30 days

• Daily check in qualitative analysis

  Up to 30 days

Study Arms (2)

Ashwagandha

EXPERIMENTAL

Generic name: ashwagandha root extract Dose form: Chloroform capsule Dose: 1 capsule 350 mg ashwagandha root extract Frequency: 2 times per day (one capsule in the morning, one capsule in the evening). Total: 700 mg ashwagandha root extract per day Duration: 30 days

Dietary Supplement: Ashwagandha

Placebo

PLACEBO COMPARATOR

Generic name: placebo Dose form: Glycerin equivalent weight to ashwagandha Dose: 1 capsule Frequency: one capsule, 2 times per day (one capsule in morning and one in evening) Duration: 30 dys

Other: Placebo

Interventions

Ashwagandha DIETARY_SUPPLEMENT

Intervention and placebo group each received a bottle of 60 capsules. Subjects were instructed to take one capsule in the morning and 1 capsule in the evening. Intervention group was getting 350 mg ashwagandha root extract per capsule (or 700 mg per day). Each intervention capsule delivered 2.5 mg withanolides with equivalence of 2,700 mg dry herb.

Also known as: Gaia Herbs, Withania somnifera

Ashwagandha

Placebo OTHER

The Placebo group received the same type of bottle with similar looking capsules. Each person in the placebo group was instructed to take 1 capsule twice a day (2 capsules total). Capsules were filled with glycerin to the same weight as ashwagandha. Capsules were indistinguishable from each other.

Also known as: glycerin

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: People of any gender identity were eligible
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Enrolled at the university

You may not qualify if:

• sensitivity to nightshade vegetables;
• peptic ulcer;
• pregnant or expected to become pregnant in the near future;
• breastfeeding;
• had recent or planned surgery;
• hypotensive;
• diagnosed with diabetes;
• and/or taking any of the following classes of medications: benzodiazepines, central nervous system depressants, diabetes medication, thyroid medication, immune suppressors, cardiovascular medication.

Sponsors & Collaborators

• University of Colorado, Colorado Springs: lead

Study Sites (1)

University of Colorado Colorado Springs

Colorado Springs, Colorado, 80918, United States

Location

Related Publications (2)

• O'Connor J, Lindsay K, Baker C, Kirby J, Hutchins A, Harris M. The Impact of Ashwagandha on Stress, Sleep Quality, and Food Cravings in College Students: Quantitative Analysis of a Double-Blind Randomized Control Trial. J Med Food. 2022 Dec;25(12):1086-1094. doi: 10.1089/jmf.2022.0040. Epub 2022 Aug 18.

  PMID: 35984871 DERIVED

• Baker C, Kirby JB, O'Connor J, Lindsay KG, Hutchins A, Harris M. The Perceived Impact of Ashwagandha on Stress, Sleep Quality, Energy, and Mental Clarity for College Students: Qualitative Analysis of a Double-Blind Randomized Control Trial. J Med Food. 2022 Dec;25(12):1095-1101. doi: 10.1089/jmf.2022.0042. Epub 2022 Aug 18.

  PMID: 35984870 DERIVED

MeSH Terms

Interventions

Ashwagandha; Glycerol

Intervention Hierarchy (Ancestors)

Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Margaret Harris, PhD

  University of Colorado, Colorado Springs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The company (Gaia Herbs) prepared the intervention and placebo and had knowledge with Intervention A and B. Neither the investigators, coordinators, subjects or data analyst had knowledge of the group designation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two groups: one intervention, one placebo

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 24, 2022
• Study Start: May 29, 2019
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

US (1)