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NCT Number: NCT07215351

Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women

The purpose of the present study is to investigate the impact of a natural dietary supplement, Inno Cleanse™, to reduce bloating in a population of otherwise healthy men and women, who claim to feel frequently bloated. Inno CleanseTM dietary supplement is manufactured in the United States under current Good Manufacturing Practices (cGMP) and is marketed by InnoSupps as a digestive health aid. It is sold in the United States on the company's website, Amazon, and in many large retail outlets. It remains a very popular product, with close to 1.4 million units sold since 2020, with a reported 66,000 units sold in the past three months.

Despite the prevalence of dietary supplements identifying as digestive aids, detoxification, and cleanses, very little research has been done to determine their effectiveness. The product appears to be well-designed, with multiple ingredients included which have scientific evidence of effectiveness. That said, and despite the overall positive reviews, there is no known clinical research to support the product's effectiveness.

Therefore, the aim of this study is to evaluate the efficacy of the Inno Cleanse product to reduce bloating and result in other positive outcomes (weight loss). This study will be run as a double-blind placebo-controlled trial, in which subjects will use the product or placebo for two weeks. It is hypothesized that treatment with the dietary supplement Inno Cleanse will result in reduced bloating, as evidenced by self-reported reductions in bloating and hunger, as well as moderate weight loss and a reduction in body circumference measures due to the reduced bloating. In addition, multiple anecdotal reports of improved skin health have been noted in those using the product. Additionally, routine blood and urine sample analysis will be performed as a secondary outcome, as a safety measure.

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Key information

Conditions

Constipation Bloating Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location status: Recruiting

Location contact

Jacquelyn Pence, PhD

CONTACT

[email protected]

901-678-1547

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • experience regular (2 or more days per week) bloating or constipation
  • able to fast a minimum of 12 hours prior to testing visit

Exclusion criteria

  • pregnant, planning to become pregnant, or breastfeeding
  • sensitivity or allergic to any components of the study product (cascara sagrada bark powder, cape aloe leaves extract, senna leaf powder, frangula bark powder fennel seed powder, bentonite clay, burdock root powder, licorice root extract, slippery elm bark powder, Capiscum annuum L. Fruit powder, milk thistle seed powder, hydroxypropyl methylcellulose, cellulose, and silicon dioxide).
  • experienced a severe allergic reaction that resulted in emergency care
  • diagnosed with medical disorders linked to digestive/gut health such as celiac disease, crohn's disease, gastroesophageal reflux disease, heartburn, irritable bowel syndrome, ulcerative colitis, ulcers, etcetera.
  • experiencing regular diarrhea
  • active infection or illness
  • diabetic
  • hypertensive
  • cardiovascular disease
  • breast, uterine, or ovarian cancer
  • uterine fibroids or endometriosis
  • taking medications or supplements that may alter gut health including but not limited to diuretics, laxatives, anti-diarrheal, anticholinergic agents, or antispasmodic agents.
  • previous adverse experience with laxatives
  • taking medications known to interact with the dietary supplement's ingredients including blood pressure medications, anticoagulants, antiplatelets, blood thinners, cholesterol-lowering medications, diuretics, water pills, estrogen based contraceptives, non-steroidal anti-inflammatory drugs, digoxin, corticosteroids, Monoamine oxidase inhibitors, insulin, medications processed in the liver, diclofenac, fluvastatin, glipizide, ibuprofen, piroxicam, phenytoin, phenobarbital, or secobarbital.
  • tobacco user
  • strenuous activity within 24 hours of testing visits
  • caffeine within 24 hours of testing visit
  • alcohol within 24 hours of testing visit

Treatment and study plan

Dietary supplement for digestive health

Dietary Supplement

Dietary supplement contains cascara sagrada bark powder, cape aloe leaves extract, senna leaf powder, frangula bark powder fennel seed powder, bentonite clay, burdock root powder, licorice root extract, slippery elm bark powder, Capiscum annuum L. Fruit powder, milk thistle seed powder, hydroxypropyl methylcellulose, and silicon dioxide.

placebo capsule

Dietary Supplement

Contains hydroxypropyl methylcellulose and cellulose

Primary outcomes

  1. Alanine transaminase

    Time frame: baseline

    Alanine transaminase measured as part of metabolic panel in international units per liter

  2. Alanine transaminase

    Time frame: 2 weeks of assigned intervention

    Alanine transaminase measured as part of metabolic panel in international units per liter

  3. Aspartate transferase

    Time frame: baseline

    Aspartate transferase measured as part of metabolic panel in international units per liter

  4. Aspartate transferase

    Time frame: 2 weeks of assigned intervention

    Aspartate transferase measured as part of metabolic panel in international units per liter

  5. Albumin

    Time frame: baseline

    Albumin measured as part of metabolic panel in grams per deciliter

  6. Albumin

    Time frame: 2 weeks of assigned intervention

    Albumin measured as part of metabolic panel in grams per deciliter

  7. Alkaline phosphatase

    Time frame: baseline

    Alkaline phosphatase measured as part of metabolic panel in international units per liter

  8. Alkaline phosphatase

    Time frame: 2 weeks of assigned intervention

    Alkaline phosphatase measured as part of metabolic panel in international units per liter

  9. Total bilirubin

    Time frame: baseline

    Total bilirubin measured as part of metabolic panel in milligrams per deciliter

  10. Total Bilirubin

    Time frame: 2 weeks of assigned intervention

    Total bilirubin measured as part of metabolic panel in milligrams per deciliter

  11. Blood urea nitrogen

    Time frame: baseline

    Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter

  12. Blood urea nitrogen

    Time frame: 2 weeks of assigned intervention

    Blood urea nitrogen measured as part of metabolic panel in milligrams per deciliter

  13. Calcium

    Time frame: baseline

    Calcium measured as part of metabolic panel in milligrams per deciliter

  14. Calcium

    Time frame: 2 weeks of assigned intervention

    Calcium measured as part of metabolic panel in milligrams per deciliter

  15. Carbon dioxide

    Time frame: baseline

    Carbon dioxide measured as part of metabolic panel in millimoles per liter

  16. Carbon dioxide

    Time frame: 2 weeks of assigned intervention

    Carbon dioxide measured as part of metabolic panel in millimoles per liter

  17. Chloride

    Time frame: baseline

    Chloride measured as part of metabolic panel in millimoles per liter.

  18. Chloride

    Time frame: 2 weeks of assigned intervention

    Chloride measured as part of metabolic panel in millimoles per liter.

  19. Creatinine

    Time frame: baseline

    Creatinine measured as part of metabolic panel in milligrams per deciliter

  20. Creatinine

    Time frame: 2 weeks of assigned intervention

    Creatinine measured as part of metabolic panel in milligrams per deciliter

  21. Estimated glomerular filtration rate

    Time frame: baseline

    Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73

  22. Estimated glomerular filtration rate

    Time frame: 2 weeks of assigned intervention

    Estimated glomerular filtration rate as part of metabolic panel in milliliters per minute per 1.73

  23. Blood Glucose

    Time frame: baseline

    Glucose measured as part of metabolic panel in milligrams per deciliter

  24. Blood Glucose

    Time frame: 2 weeks of assigned intervention

    Glucose measured as part of metabolic panel in milligrams per deciliter

  25. Potassium

    Time frame: baseline

    Potassium measured as part of metabolic panel in millimoles per liter.

  26. Potassium

    Time frame: 2 weeks of assigned intervention

    Potassium measured as part of metabolic panel in millimoles per liter.

  27. Sodium

    Time frame: baseline

    Sodium measured as part of metabolic panel in millimoles per liter.

  28. Sodium

    Time frame: 2 weeks of assigned intervention

    Sodium measured as part of metabolic panel in millimoles per liter.

  29. Total Globulin

    Time frame: baseline

    Total Globulin measured as part of metabolic panel in grams per deciliter

  30. Total Globulin

    Time frame: 2 weeks of assigned intervention

    Total Globulin measured as part of metabolic panel in grams per deciliter

  31. Total Protein

    Time frame: baseline

    Total Protein measured as part of metabolic panel in grams per deciliter

  32. Total Protein

    Time frame: 2 weeks of assigned intervention

    Total Protein measured as part of metabolic panel in grams per deciliter

  33. Albumin/globulin ratio

    Time frame: baseline

    Albumin/globulin ratio measured as part of metabolic panel

  34. Albumin/globulin ratio

    Time frame: 2 weeks of assigned intervention

    Albumin/globulin ratio measured as part of metabolic panel

  35. Blood urea nitrogen/creatinine ratio

    Time frame: baseline

    Blood urea nitrogen/creatinine ratio measured as part of metabolic panel

  36. Blood urea nitrogen/creatinine ratio

    Time frame: 2 weeks of assigned intervention

    Blood urea nitrogen/creatinine ratio measured as part of metabolic panel

  37. Hematocrit

    Time frame: baseline

    Hematocrit as part of a complete blood count panel measured as percentage

  38. Hematocrit

    Time frame: 2 weeks of assigned intervention

    Hematocrit as part of a complete blood count panel measured as percentage

  39. Hemoglobin

    Time frame: baseline

    Hemoglobin as part of a complete blood count panel measured in grams per deciliter

  40. Hemoglobin

    Time frame: 2 weeks of assigned intervention

    Hemoglobin as part of a complete blood count panel measured in grams per deciliter

  41. Mean corpuscular volume

    Time frame: baseline

    Mean corpuscular volume as part of a complete blood count panel measured in femtoliters

  42. Mean corpuscular volume

    Time frame: 2 weeks of assigned intervention

    Mean corpuscular volume as part of a complete blood count panel measured in femtoliters

  43. Mean corpuscular hemoglobin

    Time frame: baseline

    Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms

  44. Mean corpuscular hemoglobin

    Time frame: 2 weeks of assigned intervention

    Mean corpuscular hemoglobin as part of a complete blood count panel measured in picograms

  45. Mean corpuscular hemoglobin concentration

    Time frame: baseline

    Mean corpuscular hemoglobin concentration as part of a complete blood count panel measured in grams per deciliter

  46. Mean corpuscular hemoglobin concentration

    Time frame: 2 weeks of assigned intervention

    Mean corpuscular hemoglobin concentration as part of a complete blood count panel measured in grams per deciliter

  47. Red cell distribution width

    Time frame: baseline

    Red cell distribution width as part of a complete blood count panel measured as a percentage

  48. Red cell distribution width

    Time frame: 2 weeks of assigned intervention

    Red cell distribution width as part of a complete blood count panel measured as a percentage

  49. Platelets

    Time frame: baseline

    Platelets as part of a complete blood count panel measured as a count per 1000 per microliter

  50. Platelets

    Time frame: 2 weeks of assigned intervention

    Platelets as part of a complete blood count panel measured as a count per 1000 per microliter

  51. Specific gravity

    Time frame: baseline

    Specific gravity as measured as part of urinalysis (no units)

  52. Specific gravity

    Time frame: 2 weeks of assigned intervention

    Specific gravity as measured as part of urinalysis (no units)

  53. pH

    Time frame: baseline

    pH as measured as part of urinalysis (no units)

  54. pH

    Time frame: 2 weeks of assigned intervention

    pH as measured as part of urinalysis (no units)

  55. Urine color

    Time frame: baseline

    Urine color as reported as part of urinalysis (no units)

  56. Urine color

    Time frame: 2 weeks of assigned intervention

    Urine color as reported as part of urinalysis (no units)

  57. Urine Appearance

    Time frame: baseline

    Urine Appearance as reported as part of urinalysis (no units)

  58. Urine Appearance

    Time frame: 2 weeks of assigned intervention

    Urine Appearance as reported as part of urinalysis (no units)

  59. White Blood Cell esterase

    Time frame: baseline

    White blood cell esterase as measured as part of urinalysis, if present

  60. White blood cell esterase

    Time frame: 2 weeks of assigned intervention

    White blood cell esterase as measured as part of urinalysis, if present

  61. Protein

    Time frame: baseline

    Protein as measured as part of urinalysis, if present

  62. Protein

    Time frame: 2 weeks of assigned intervention

    Protein as measured as part of urinalysis, if present

  63. Glucose

    Time frame: baseline

    Glucose as measured as part of urinalysis, if present

  64. Glucose

    Time frame: 2 weeks of assigned intervention

    Glucose as measured as part of urinalysis, if present

  65. Ketones

    Time frame: baseline

    Ketones as measured as part of urinalysis, if present

  66. Ketones

    Time frame: 2 weeks of assigned intervention

    Ketones as measured as part of urinalysis, if present

  67. Occult blood

    Time frame: baseline

    Occult blood as measured as part of urinalysis, if present

  68. Occult blood

    Time frame: 2 weeks of assigned intervention

    Occult blood as measured as part of urinalysis, if present

  69. Bilirubin

    Time frame: baseline

    Bilirubin as measured as part of urinalysis, if present

  70. Bilirubin

    Time frame: 2 weeks of assigned intervention

    Bilirubin as measured as part of urinalysis, if present

  71. Urobilinogen

    Time frame: baseline

    Urobilinogen as measured as part of urinalysis in milligrams per deciliter

  72. Urobilinogen

    Time frame: 2 weeks of assigned intervention

    Urobilinogen as measured as part of urinalysis in milligrams per deciliter

  73. Microscopic examination

    Time frame: baseline

    Microscopic examination as reported as part of urinalysis, if indicated

  74. Microscopic examination

    Time frame: 2 weeks of assigned intervention

    Microscopic examination as reported as part of urinalysis, if indicated

  75. Total Cholesterol

    Time frame: baseline

    Total Cholesterol as reported as part of lipid panel in milligrams per deciliter

  76. Total Cholesterol

    Time frame: 2 weeks of assigned intervention

    Total Cholesterol as reported as part of lipid panel in milligrams per deciliter

  77. Triglycerides

    Time frame: baseline

    Triglycerides as reported as part of lipid panel in milligrams per deciliter

  78. Triglycerides

    Time frame: 2 weeks of assigned intervention

    Triglycerides as reported as part of lipid panel in milligrams per deciliter

  79. High-Density Lipoprotein Cholesterol

    Time frame: baseline

    High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter

  80. High-Density Lipoprotein Cholesterol

    Time frame: 2 weeks of assigned intervention

    High-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter

  81. Very Low-Density Lipoprotein Cholesterol

    Time frame: baseline

    Very Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter

  82. Very Low-Density Lipoprotein Cholesterol

    Time frame: 2 weeks of assigned intervention

    Very Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter

  83. Low-Density Lipoprotein Cholesterol

    Time frame: baseline

    Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter

  84. Low-Density Lipoprotein Cholesterol

    Time frame: 2 weeks of assigned intervention

    Low-Density Lipoprotein Cholesterol as reported as part of lipid panel in milligrams per deciliter

  85. Mood questionnaire

    Time frame: baseline

    Visual analog scale used to assess mood (attentive, tired, alert, groggy, focused, sluggish, energetic, lethargic, fatigued, mental clarity, motivation, happiness, and feeling from 0 (None) to 10 (Extreme) as well as "Flushed out" from 0 (not at all) to 10 (completely empty)

  86. Mood questionnaire

    Time frame: 2 weeks of assigned intervention

    Visual analog scale used to assess mood (attentive, tired, alert, groggy, focused, sluggish, energetic, lethargic, fatigued, mental clarity, motivation, happiness, and feeling from 0 (None) to 10 (Extreme) as well as "Flushed out" from 0 (not at all) to 10 (completely empty)

  87. 36-item short form survey

    Time frame: baseline

    36-item questionnaire that measures health-related quality of life with responses used to calculate scores on a scale of 0-100, where higher scores indicate better health.

  88. 36-item short form survey

    Time frame: 2 weeks of assigned intervention

    36-item questionnaire that measures health-related quality of life with responses used to calculate scores on a scale of 0-100, where higher scores indicate better health.

  89. Tolerability Questionnaire

    Time frame: baseline

    18 item questionnaire covering upper abdominal, lower abdominal, and other symptoms using a 0-9 scale (0-no problem at all to 9-the worst it has ever been)

  90. Tolerability Questionnaire

    Time frame: 1 day of assigned treatment

    18 item questionnaire covering upper abdominal, lower abdominal, and other symptoms using a 0-9 scale (0-no problem at all to 9-the worst it has ever been)

  91. Tolerability Questionnaire

    Time frame: 3 days of assigned treatment

    18 item questionnaire covering upper abdominal, lower abdominal, and other symptoms using a 0-9 scale (0-no problem at all to 9-the worst it has ever been)

  92. Tolerability Questionnaire

    Time frame: 1 week of assigned treatment

    18 item questionnaire covering upper abdominal, lower abdominal, and other symptoms using a 0-9 scale (0-no problem at all to 9-the worst it has ever been)

  93. Tolerability Questionnaire

    Time frame: 2 weeks of assigned treatment

    18 item questionnaire covering upper abdominal, lower abdominal, and other symptoms using a 0-9 scale (0-no problem at all to 9-the worst it has ever been)

  94. Bristol Chart

    Time frame: 3 days before baseline

    Self-reported number and consistency of daily bowel movements

  95. Bristol Chart

    Time frame: 2 days before baseline

    Self-reported number and consistency of daily bowel movements

  96. Bristol Chart

    Time frame: 1 day before baseline

    Self-reported number and consistency of daily bowel movements

  97. Bristol Chart

    Time frame: 1 day of assigned treatment

    Self-reported number and consistency of daily bowel movements

  98. Bristol Chart

    Time frame: 2 days on assigned treatment

    Self-reported number and consistency of daily bowel movements

  99. Bristol Chart

    Time frame: 3 days of assigned treatment

    Self-reported number and consistency of daily bowel movements

  100. Bristol Chart

    Time frame: 7 days of assigned treatment

    Self-reported number and consistency of daily bowel movements

  101. Bristol Chart

    Time frame: 14 days of assigned treatment

    Self-reported number and consistency of daily bowel movements

  102. Weight

    Time frame: baseline

    Body weight measured in kg

  103. Weight

    Time frame: 2 weeks of assigned treatment

    Body weight measured in kg

  104. Skin age

    Time frame: baseline

    a quantitative skin age based on skin parameters will be determined by the 3D P Plus system

  105. Skin age

    Time frame: 2 weeks of assigned treatment

    a quantitative skin age based on skin parameters will be determined by the 3D P Plus system

  106. Diastolic blood pressure

    Time frame: baseline

    Diastolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury

  107. Diastolic blood pressure

    Time frame: 2 weeks of assigned treatment

    Diastolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury

  108. Systolic blood pressure

    Time frame: baseline

    Systolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury

  109. Systolic blood pressure

    Time frame: 2 weeks of assigned treatment

    Systolic blood pressure will be measured using an automated blood pressure machine in units millimeters of mercury

  110. Heart rate

    Time frame: baseline

    Heart rate will be measured using an automated blood pressure machine in units beats per minute

  111. Heart Rate

    Time frame: 2 weeks of assigned treatment

    Hear rate will be measured using an automated blood pressure machine in units beats per minute

Secondary outcomes

  1. Daily food diary

    Time frame: 3 days prior to baseline visit

    Daily food diary of all food and drink consumed that day

  2. Daily food diary

    Time frame: 2 days prior to baseline visit

    Daily food diary of all food and drink consumed that day

  3. Daily food diary

    Time frame: 1 day prior to baseline visit

    Daily food diary of all food and drink consumed that day

  4. Daily food diary

    Time frame: 3 days prior to 2 week visit

    Daily food diary of all food and drink consumed that day

  5. Daily food diary

    Time frame: 2 days prior to 2 week visit

    Daily food diary of all food and drink consumed that day

  6. Daily food diary

    Time frame: 1 day prior to 2 week visit

    Daily food diary of all food and drink consumed that day

Study contacts

Contact information is provided by the study sponsor or research team.

Jacquelyn Pence, PhD

CONTACT

[email protected]

901-678-1547

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • INNOSUPPS

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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