Effectiveness of an African spice fruit on weight, mood, and health-related quality of life

Not Applicable

Completed

• Conditions: Treatment of overweight and mild obesity; Not Applicable

• Registration Number: ISRCTN10099861
• Lead Sponsor: Gateway Alliances

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-06-01
• Study Start: 2023-12-11
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Overweight and mildly obese adults (BMI between 25.00 to 34.99 kg/m²)

Exclusion Criteria

1. Any metabolic or endocrine related dysregulation including but not limited to: diagnosis of type I or type II diabetes, liver, kidney, or pancreatic dysfunction
2. History of sleep-affecting disorders
3. Recent highly stressful events within 4 weeks of baseline
4. Usage of weight-influencing medications within 1 month of baseline
5. Use of Ca channel blockers, anxiolytics or SSRIs, no more than 5 times per month, and not within seven days of baseline
6. Unstable use of other medication
7. Current hormone therapy
8. Excessive alcohol consumption
9. Smoking
10. Elevated caffeine intake
11. Irregular sleep-inducing work schedules
12. Inability to engage in spontaneous physical activity
13. Metabolic disorder, a sleep disorder, or a psychiatric condition
14. Pregnancy, attempts at conception, or breastfeeding
15. Use of sleep/weight supplements or medications
16. Actively intermittent fasting, are actively trying to lose weight, or have lost more than ± 3kg in previous 3 months
17. Individuals deemed incompatible with the study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified