Body Composition, Gastrointestinal Health, Gut Health, Hair Growth, Healthy Weight Management, Skin Appearance
Conditions
Brief summary
This study evaluates the effects of Cowboy Colostrum bovine colostrum powder on gut health, body composition, hair growth, and skin appearance in generally healthy adults aged 21-47 with concerns in these areas. The trial is a single-arm, unblinded, virtual study conducted over 12 weeks in 35 participants who will use the test product daily. Participants will complete questionnaires and provide weight and waist circumference measurements at Baseline, Week 4, Week 8, and Week 12. The primary focus is on changes in weight and waist circumference, while secondary outcomes include participants' perceptions of gastrointestinal health, physical activity, hair growth, skin appearance, and overall health and well-being.
Interventions
DIETARY_SUPPLEMENTCowboy Colostrum
All participants take two scoops of Cowboy Colostrum bovine colostrum powder daily (3.4 g serving containing 3 g bovine colostrum, organic Madagascar vanilla powder, monkfruit extract, and sea salt), either directly in the mouth or frothed into cold or warm liquids such as water, iced coffee, iced matcha, smoothies, yogurt, or oatmeal at any time of day for 12 weeks. The product must not be added to any liquid over 140 degrees.
Sponsors
Cowboy Colostrum
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 47 Years
Healthy volunteers
Yes
Inclusion criteria
* Be male or female * Be aged 21-47 * Anyone with concerns regarding all of the following over the past four weeks: gut health, healthy weight management, hair growth, and skin appearance * BMI 25-33 kg/m² * Anyone who is generally healthy and does not live with any uncontrolled chronic disease * Anyone who is physically active at least once per week * If taking any products, herbal remedies, over-the-counter medications, or supplements that target weight, gut health, physical activity, hair growth, or skin appearance, has been doing so consistently for three months and is willing to maintain this routine for the study duration * Willing to maintain their current diet and sleep schedule for the duration of the study * Willing to use the same skincare routine and make-up products for at least one month prior to the study, and willing to maintain this routine for the duration of the study * Resides in the United States
Exclusion criteria
* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders * Anyone who has undergone any surgeries or invasive treatments in the last six months, or has any planned during the study period * Has had any major illness in the last three months * Anyone who has taken an antibiotic in the last three months * Anyone currently taking a weight loss medication, including but not limited to Wegovy, Mounjaro, and Ozempic * History of an autoimmune disorder, diabetes, or endocrine disorder * Food intolerances, allergies, or sensitivities such as dairy allergy and lactose intolerance * Has a known history of severe digestive disorders like acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, or gastrointestinal tract surgeries * Anyone diagnosed with a skin or hair condition * Anyone who does not consume animal products for any reason * Currently undergoing hair treatment or using other hair growth/thickening products * Currently taking any prescription medication for hair loss * Anyone with any conditions that affect the hair or scalp (e.g., alopecia areata) * Anyone planning to undergo facial treatments during the study period, including Botox, dermal fillers, and chemical peels * Anyone with any allergies or sensitivities to any of the study product ingredients * Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period) * Heavy drinkers, defined as a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week * Anyone unwilling to follow the study protocol * Anyone with a history of substance abuse * Anyone who is currently a smoker or has been a smoker in the past 3 months * Currently partaking in another research study or will be partaking in any other research study for the next 12 weeks or at any point during this study's duration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline, Week 4, Week 8, and Week 12 | Self-reported body weight measured daily for three consecutive days at each time point using a Withings smart scale; the average of the two closest values is used |
| Change in Waist Circumference | Baseline, Week 4, Week 8, and Week 12 | Self-reported waist circumference measured using a tape measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastrointestinal Symptoms | Baseline, Week 4, Week 8, and Week 12 | Assessed via the Gastrointestinal Symptoms Rating Scale (GSRS) self-report questionnaire |
| Change in Digestion-associated Quality of Life | Baseline, Week 4, Week 8, and Week 12 | Assessed via the Digestion-associated Quality of Life questionnaire (DQLQ) self-report questionnaire |
| Change in Physical Activity | Baseline, Week 4, Week 8, and Week 12 | Assessed via the Godin Leisure-Time Exercises Questionnaire (GLTE) self-report questionnaire |
| Participants' Perception of Bloating | Baseline, Week 4, Week 8, and Week 12 | Assessed via self-report questionnaire item |
| Participants' Perception of Bowel Movement Frequency | Baseline, Week 4, Week 8, and Week 12 | Assessed via self-report questionnaire item |
| Participants' Perception of Digestion | Baseline, Week 4, Week 8, and Week 12 | Assessed via self-report questionnaire item |
| Participants' Perception of Healthy Weight Management | Baseline, Week 4, Week 8, and Week 12 | Assessed via self-report questionnaire item |
| Participants' Perception of Energy Levels | Baseline, Week 4, Week 8, and Week 12 | Assessed via self-report questionnaire item |
| Participants' Perception of Hair Growth | Baseline, Week 4, Week 8, and Week 12 | Assessed via self-report questionnaire item |
| Participants' Perception of Hair Texture | Baseline, Week 4, Week 8, and Week 12 | Assessed via self-report questionnaire item |
| Participants' Perception of Skin Brightness | Baseline, Week 4, Week 8, and Week 12 | Assessed via self-report questionnaire item |
| Participants' Perception of Skin Clearness | Baseline, Week 4, Week 8, and Week 12 | Assessed via self-report questionnaire item |
| Participants' Perception of Product Efficacy | Baseline, Week 4, Week 8, and Week 12 | Assessed via self-report questionnaire item |
Countries
United States
Outcome results
None listed