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

Effectiveness of African spice fruit (Dichrostachys glomerate) supplementation on overweight and mildly obese adult’s weight, mood, and health-related quality of life: a randomized double-blind placebo-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10099861
Enrollment
60
Registered
2023-12-11
Start date
2023-01-02
Completion date
Unknown
Last updated
2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of overweight and mild obesity Not Applicable

Interventions

This study was conducted in a double-blind, parallel treatment, stratified random, placebo-controlled manner. The independent variable was the Dichrostachys glomerata nutritional supplementation. The

Sponsors

Gateway Alliances
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Weight (kg) measured using a smart scale (BodyTrace, Inc.), at Baseline, Day 30 and Day 60.

Secondary

MeasureTime frame
1. Food cravings measured using the Food Cravings Questionnaire (Meule et al., 2014) at Baseline, Day 30 and Day 60. 2. Health-related quality of life measured using the CDC Health-related Quality of Life Core Healthy Days at Baseline, Day 30 and Day 60. 3. Mood measured using Profile of Mood States (POMS) Questionnaire (McNair et al., 1992) at Baseline, Day 30, and Day 60. 4. Anxiety measured using the Trait Anxiety Inventory (Spielberger et al., 1983) at Baseline, Day 30, and Day 60. 5. Perceived stress measured using the Perceived Stress Scale-4 (Cohen et al., 1983) at Baseline, Day 30, and Day 60.

Countries

United States of America

Contacts

Public ContactHeather Hausenblas
hhausenblas@wellnessdiscoverylabs.com+1 9048919746

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026