Effectiveness of an African spice fruit on weight, mood, and health-related quality of life
| ISRCTN | ISRCTN10099861 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10099861 |
| Secondary identifying numbers | NIl known |
- Submission date
- 08/12/2023
- Registration date
- 11/12/2023
- Last edited
- 24/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Background and study aims
This study aimed to investigate the effects of a herbal product called Dyglomera® made from Dichrostachys glomerata fruit pods
Who can participate?
Overweight and mildly obese adults aged 25 - 60 years
What does the study involve?
Participants were randomly divided into two groups, one receiving Dyglomera® and the other a placebo. They were assessed for weight, food cravings, mood, and quality of life over 60 days.
What are the possible benefits and risks of participating?
Where is the study run from?
Wellness Discovery Labs (USA)
When is the study starting and how long is it expected to run for?
November 2022 to June 2023
Who is funding the study?
Gateway Alliances (USA)
Who is the main contact?
Prof Heather Hausenblas, hhausenblas@wellnessdiscoverylabs.com
Contact information
Prof Heather Hausenblas
Public, Scientific, Principal Investigator
Public, Scientific, Principal Investigator
3525 Pine St
Jacksonville
32205
United States of America
 ORCID ID |
0000-0002-0127-9184 |
|---|---|
| Phone | +1 9048919746 |
| hhausenblas@wellnessdiscoverylabs.com |
Study information
| Study design | Randomized double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | 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 |
| Study hypothesis | The purpose of this study was to investigate the weight, food cravings, mood, and health-related quality of life effects of Dyglomera® on overweight and mildly obese adults |
| Ethics approval(s) |
Approved 11/11/2022, Sterling IRB (6300 Powers Ferry Rd Suite 600-351, Atlanta, 30339, United States of America; +1 888-636-1062; support@sterlingirb.com), ref: 10504-HAHausenblas |
| Condition | Treatment of overweight and mild obesity |
| Intervention | 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 dependent variables were body weight (primary outcome) and food cravings, mood, anxiety, stress, and health-related quality of life (secondary outcomes). Sample size power calculation indicated that 35 participants were needed in each group to achieve a power of 80% and alpha < .05 (https://clincalc.com/stats/samplesize.aspx). Procedures: Following preliminary screening, eligible participants provided Institutional Review Board approved informed consent prior to enrolment. Participants completed psychometrically validate self-report questionnaires on Day 0 (Pre), Day 30, and Day 60. In addition, participants maintained a daily diary to document adherence and adverse events. Participants completed the self-report surveys via a SurveyMonkey link that was sent via email or text. Completion of the surveys took about 25 minutes at each assessment. Participants were instructed to maintain their habitual lifestyle patterns and refrain from introducing new exercise, diet, or health interventions during the study. These data were collected from March 2023 to June 2023 and were stored electronically. Intervention: A randomized double-blind placebo-controlled trial design was employed, with participants randomly assigned to either the Dichrostachys glomerata group (DG) or Placebo Control Group (PC) for the duration of the two-month trial. We used a computer-based randomization via SPSS to automate the random assignment process. Participants were directed to consume 300 mg, 1/d of the allocated substance. Dyglomera®, an aqueous ethanol extract of Dichrostachys glomerata fruit pods (standardized to Myricetin 1.6% and Luteolin 1.0%), was supplied by Gateway Health Alliances, Inc (https://www.ghainc.com/; Fairfield, CA, USA). The manufacturing process was as follows: Dichrostachys glomerata fruit pods were extracted using aqueous ethanol. The resulting solution was concentrated and dried to yield Dyglomera®. The placebo was rice protein. |
| Intervention type | Supplement |
| Primary outcome measure | Weight (kg) measured using a smart scale (BodyTrace, Inc.), at Baseline, Day 30 and Day 60. |
| Secondary outcome measures | 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. |
| Overall study start date | 11/11/2022 |
| Overall study end date | 01/06/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 61 |
| Participant inclusion criteria | Overweight and mildly obese adults (BMI between 25.00 to 34.99 kg/m²) |
| Participant 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 |
| Recruitment start date | 02/01/2023 |
| Recruitment end date | 04/01/2023 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Wellness Discovery Labs
76 S Laura St
Jacksonville
32202
United States of America
Jacksonville
32202
United States of America
Sponsor information
Gateway Alliances
Industry
Industry
Gateway Health Alliances, Inc.
4769 Mangels Blvd
Fairfield
94534
United States of America
| Phone | +1 707-863-0265 |
|---|---|
| skothari@ghainc.com | |
| Website | https://www.ghainc.com/ |
Funders
Funder type
Industry
Gateway Health Alliances
No information available
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Data and/or statistical analyses are available upon request on a case-by-case basis for noncommercial scientific inquiry and/or educational use as long as Institutional Review Board restrictions and research agreement terms are not violated. Contact H. Hausenblas at hhausen@ju.edu |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/09/2024 | 24/09/2024 | Yes | No |
Editorial Notes
24/09/2024: Publication reference added.
11/12/2023: Trial's existence confirmed by Sterling IRB.
