Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    curcumin denver

RCT of Adjunctive Curcumin and the Meru Health Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04744545
Recruitment Status : Not yet recruiting
First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Meru Health, Inc.

Brief Summary:
This is a randomized controlled trial (RCT) to compare the Meru Health Program plus adjunctive curcumin (MHP-CUR) versus Meru Health Program only (MHP-ONLY) for adults with depression. Meru Health is a 12-week integrative treatment program based on several evidence-based practices and overseen by licensed clinical therapists that is delivered via a Smartphone app. The primary objective of the study is to determine the feasibility, initial efficacy (depressive symptoms), and potential harms of taking adjunctive curcumin supplementation during the 12-week MHP among adults with depression. Secondary objectives include comparing changes in inflammation biomarkers, anxiety, worker productivity, and burnout that occur during the program between those in MHP-CUR and MHP-ONLY.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Meru Health Program Dietary Supplement: Curcumin Not Applicable

Detailed Description:

This is a randomized controlled trial (RCT) to compare the Meru Health Program plus adjunctive curcumin (MHP-CUR) versus Meru Health Program only (MHP-ONLY) for adults with depression. Meru Health is a 12-week integrative treatment program based on several evidence-based practices and overseen by licensed clinical therapists that is delivered via a Smartphone app. The primary objective of the study is to determine the feasibility, initial efficacy (depressive symptoms), and potential harms of taking adjunctive curcumin supplementation during the 12-week MHP among adults with depression. Secondary objectives include comparing changes in inflammation biomarkers, anxiety, worker productivity, and burnout that occur during the program between those in MHP-CUR and MHP-ONLY.

This feasibility study will use a randomized controlled trial of up to 60 adult patients with depression. Patients will be recruited through Facebook ads, complete online and telephone/Zoom screening and, if eligible, invited to participate in the 12-week Meru Health program. One group will be randomized to being in the MHP plus receiving curcumin supplementation (MHP-CUR) and the other will be randomized to being in the MHP only (MHP-only). The MHP overseen by a licensed therapist who is available to the participant as needed via text messaging and, when requested, telephone. The program is delivered via an app downloaded to the user's Smartphone made available via email. The lab orders will be sent to each patient's Ultalabs center of choice or, if preferred, done in the patient's home. All study participants (in both groups) will be asked to get their blood drawn before starting the program, 6 weeks into the program, and just after the 12-week program. Two vials of blood will be taken at each visit, one to test for high sensitivity-CRP (hs-CRP) levels and the other to test for interleukin (IL-6) levels. 2ml of serum is needed for each vial. Patients in both groups will receive a wearable HRVB device via US mail; patients in the MHP-CUR group will also receive curcumin supplements via US mail. All non-laboratory study assessments will be made via the app and online via email.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with two study groups.
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessors will not have information about each participant's study group.
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Adjunctive Curcumin and the Meru Health Program for Adults With Depression
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Meru Health Program plus adjunctive curcumin (MHP-CUR)
Meru Health Program (12 week program) with participants taking 2 turmeric supplements (1500mg/day) curcumin.
Behavioral: Meru Health Program
12 week evidence-based mental health intervention overseen by a licensed clinical therapist delivered via Smartphone app

Dietary Supplement: Curcumin
1500mg/day curcumin plus black pepper to aid absorption

Active Comparator: Meru Health Program (MHP-ONLY)
Meru Health Program (12 week program)
Behavioral: Meru Health Program
12 week evidence-based mental health intervention overseen by a licensed clinical therapist delivered via Smartphone app




Primary Outcome Measures :
  1. Depression [ Time Frame: 12 weeks ]
    Mean changes in the Patient Health Questionnaire, 9 item scale (PHQ-9) made during the program will be calculated. Scores range from 0 (no depression) to 27 (most severe depression)

  2. Patient-reported adverse events [ Time Frame: during the 12 week program ]
    The proportion of patients reporting at least one adverse event during the 12-week intervention will be reported.


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: 12 weeks ]
    Mean changes in the Generalized Anxiety Disorder-7 item scale (GAD-7) will be reported. GAD-7 scores range from 0 (no anxiety) to 21 (most severe anxiety)

  2. Burnout [ Time Frame: 12 weeks ]
    The proportion of patients with changes in burnout will be reported. A validated, single-item burnout question will be used to assess burnout that has 5 response categoreis ranging from 1 (no burnout) to 5 (completed burned out) and dichotomized as <3 (no to low burnout) versus >=3 (at least moderate levels of burnout)

  3. Worker productivity and activity impairment [ Time Frame: 12 weeks ]
    The mean percent difference in each of the 4 subscales of the Worker Productivity and Activity Impairment (WPAI) scale will be reported. Subscales include absenteeism, presenteeism, overall worker productivity impairment, and impairment with daily activities and range from 0 (no impairment) to 100% (complete impairment).

  4. Therapist rating [ Time Frame: 12 weeks ]
    The proportion of patients who reported being satisfied with their program therapist will be reported as dichotmized by a 5-category scale that ranges from 1 (not at all satisfied) to 5 (extremely satisfied). Responses "1" and "2" (not at all satisfied and not satisfied) will be combined into a "not satisfied" dichotomous category and responses 2 (satisfied), 3 (very satisfied) and 4 (extremely satisfied) will be combined into a "satisfied" dichotomous category, with the proportion of patients falling into each category being reported.

  5. Interleukin-6 [ Time Frame: 12 weeks ]
    Mean changes in Interleukin-6 (IL-6) will be calculated for each participant to measure changes in inflammation made during the program.

  6. High Sensitivity C Reactive Protein [ Time Frame: 12 weeks ]
    Mean changes in high-sensitivity c reactive protein (hs-crp) will be calculated for each participant to measure changes in inflammation made during the program.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or older
  • Patient presenting to the Meru Health online clinic
  • Able to read and understand English
  • Own a Smartphone
  • Willing to commit to doing program practices for 10 minutes a day, 6 days a week for 12 weeks
  • PHQ-9 of 10 or higher

Exclusion Criteria:

  • Lifetime bipolar disorder or a psychotic disorder
  • Possible cognitive impairment
  • Substance use disorder in the past 3 months
  • Active suicidal ideation with at least some intent to act
  • Pregnant, breastfeeding, or desiring to become pregnant in the next 6 months
  • Self-reported current suffering from a major medical illness including neurodegenerative/neuroinflammatory disorders, anemia, Alzheimer's disease, stroke, Parkinson's disease, or multiple sclerosis, autoimmune disorders, diabetes, inflammatory bowel disease, chronic obstructive pulmonary disease, asthma, coagulation disorder, cardiovascular disease, hypertension, chronic fatigue syndrome, fibromyalgia
  • Self-reported current use of glucocorticoids, antibiotics, anticoagulant medications, antioxidant supplements (including curcumin), herbal supplements, or ω3 polyunsaturated fatty acids
  • Self-reported past suffering from an infection or illness over the past month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04744545


Contacts
Layout table for location contacts
Contact: Valerie F Hoffman, PhD, MPH 13193214901 valerie@meruhealth.com

Locations
Layout table for location information
United States, Colorado
Online
Denver, Colorado, United States, 80014
Sponsors and Collaborators
Meru Health, Inc.
Layout table for additonal information
Responsible Party: Meru Health, Inc.
ClinicalTrials.gov Identifier: NCT04744545    
Other Study ID Numbers: #20-MERU-106
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Curcumin
Depression
Behavioral Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action