An Open-Label Pilot Study to Evaluate the Effects and Safety of the Satiety-Enhancing Topical Formulation TDW on Cravings and Satiety in Obese Adults.
Overview
- Phase
- Post Marketing Surveillance
- Status
- Completed
- Sponsor
- Urrth Naturals LLP
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- 1 Improvement in satiety (measured by New Zealand Eating Behavior Questionnaire (NZ EBQ)
Overview
Brief Summary
This is an open-label pilot clinical study designed to assess the effects and safety of a topical formulation, TDW, intended to enhance satiety and reduce food cravings in obese adults. The study will evaluate changes in self-reported satiety levels and cravings over the treatment period, along with monitoring for any adverse effects to determine the product’s tolerability and feasibility for further clinical development.
Study Design
- Study Type
- Pms
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 25.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •To participate in the study subjects must meet the following criteria 1 Age Male and female participants aged 25 to 60 years 2 Body Mass Index (BMI) BMI between 30.0 to 34.9 kilograms per square meter (Class I obesity) 3 Physical Activity Engaging in at least 30 minutes of moderate physical activity per day on most days of the week five or more days per week, and willing to maintain this activity level throughout the study period 4 Subjective Satiety Dysfunction Participants who score less than or equal to 19 on the Satiety Subscale of the New Zealand Eating Behaviour Questionnaire (NZ-EBQ) indicating moderate to poor satiety regulation 5 High Food Cravings Participants who score greater than or equal to 70 millimeters on VAS for Desire to Eat or Hunger OR self-report persistent cravings for unhealthy snacks despite regular meals 6.Subjective Hunger Index Baseline VAS score for Hunger greater than or equal to 60 millimeters out of 100 mm indicating elevated appetite levels.
- •7 Motivated for Diet Control Participants who selfreport difficulty adhering to a diet despite efforts at weight loss or dietary regulation 8 Consent and Compliance Willing and able to provide written informed consent and comply with all study procedures including daily application of the patch and completion of appetite mood questionnaires.
Exclusion Criteria
- •A subject will be considered unsuitable for the study if they meet any one of the following criteria: 1 Use of appetite suppressants or weight loss medications 2 Presence of metabolic disorders eg diabetes thyroid disease 3 Significant skin conditions or known allergies especially those that may interfere with topical applications 4 Recent participation in any weight loss programs or clinical trials 5 Pregnancy or lactation 6 Current smokers 7 Heavy alcohol consumption.
Outcomes
Primary Outcomes
1 Improvement in satiety (measured by New Zealand Eating Behavior Questionnaire (NZ EBQ)
Time Frame: Visit-1 | Screening | (Day 0) Baseline | Visit-2 | (Day 15) + 2 days | Visit-3 and EOS | (Day 45) + 2 days
2 Reduction in cravings for snacking:
Time Frame: Visit-1 | Screening | (Day 0) Baseline | Visit-2 | (Day 15) + 2 days | Visit-3 and EOS | (Day 45) + 2 days
1 measured by Snacking Craving Scale Validated 3 Item VAS
Time Frame: Visit-1 | Screening | (Day 0) Baseline | Visit-2 | (Day 15) + 2 days | Visit-3 and EOS | (Day 45) + 2 days
2 measured by Visual Analogue Scale VAS Appetite Assessment
Time Frame: Visit-1 | Screening | (Day 0) Baseline | Visit-2 | (Day 15) + 2 days | Visit-3 and EOS | (Day 45) + 2 days
Secondary Outcomes
- 1 Change in mood measured by Profile of Mood States POMS(2 Change in perceived stress measured by Perceived Stress Scale PSS)
Investigators
DrDipti Gupta
Tulsi Multispeciality Hospital.