Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
Parole chiave
Astratto
Descrizione
Rationale: Current treatment strategies for Nonalcoholic fatty liver disease, NAFLD, have focused on lifestyle management through a combination of diet and exercise but there are no recommendations for dietary changes that have been proven superior to others. Preliminary data showing an improvement in liver enzymes and fibrosis in mice has demonstrated a novel use of rebaudioside, the non-caloric sweetener (NCS) Stevia leaf's extract, potentially identifying this NCS as a therapeutic intervention where currently there are no targeted treatments.
Intervention: All participants will receive standard of care for diet and nutrition. Additionally, participants will be randomized to one of four 8-week liquid diet interventions:
1. Standard of Care
2. Water Delivery
3. Water with Rebaudioside (Stevia Natural Sweetener)
Objectives and Purpose: To determine whether rebaudioside consumption can be used as a treatment for adolescents with NAFLD by demonstrating a decrease in ALT levels.
Date
| Ultimo verificato: | 10/31/2019 |
| Primo inviato: | 06/05/2019 |
| Iscrizione stimata inviata: | 06/11/2019 |
| Primo pubblicato: | 06/12/2019 |
| Ultimo aggiornamento inviato: | 11/12/2019 |
| Ultimo aggiornamento pubblicato: | 11/13/2019 |
| Data di inizio effettiva dello studio: | 07/25/2019 |
| Data di completamento primaria stimata: | 09/07/2020 |
| Data stimata di completamento dello studio: | 12/07/2020 |
Condizione o malattia
Intervento / trattamento
Other: Stevia Intervention
Other: Water Intervention
Fase
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| No Intervention: Standard of Care The control group will receive standard of care dietary advice for their solid food and beverage intake. | |
| Active Comparator: Water Intervention We will order and deliver bottled water to the homes of subjects in the treatment group. We will provide each participant with a weekly supply of about 36 16.9 fl oz single-serving containers. We will instruct subjects to notify us by calling a dedicated telephone line on occasions when a delivery is expected but not received so that the problem can be corrected expeditiously. | Other: Water Intervention Bottled Water |
| Experimental: Stevia Intervention We will order and deliver a commercially-available stevia-sweetened soft drink Zevia (Los Angeles, CA) to each participant in the treatment group. We will provide each participant with a weekly supply of 24 12 fl oz single-serving containers. Zevia will be provided in an assortment of flavors for the first week, then catered to the preference of the participant for the remainder of the study. We will instruct subjects to notify us by calling a dedicated telephone line on occasions when a delivery is expected but not received so that the problem can be corrected expeditiously. Participants will also be asked to keep track of how many containers they consume using a sticker chart, and we will also phone parents weekly to verify the sticker charts | Other: Stevia Intervention We will use commercially available stevia sweetened soft drink Zevia. |
Criteri di idoneità
| Età idonea per lo studio | 10 Years Per 10 Years |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | Inclusion Criteria: - Age: 10-18 years - ALT > 45 IU/L (twice the normal amount) - BMI >85% - Fat >5% and kPa> 2.7 Exclusion Criteria: - Physician diagnosis of a major medical illness including, but not limited to, chronic liver disease, immunodeficiency disorder, hypothalamic obesity, or a genetic cause of obesity. - Familial hyperlipidemia - Positive hepatitis lab - Antibiotics within 1 month of beginning the study - Physical, mental, or cognitive issues preventing participation - Pregnancy - Smoking or drinking |
Risultato
Misure di esito primarie
1. Change in ALT [Week 1 to week 8 (IU/L)]
Misure di esito secondarie
1. Change in Fat percentage [week 1 to 8 weeks (%)]
2. Change in kPA levels [week 1 to 8 weeks (kPA)]
3. Change in Height [week 1 to 8 weeks (cm)]
4. Change in Weight [week 1 to 8 weeks (kg)]
5. Change in Waist Circumference [week 1 to 8 weeks (cm)]
6. Change in Acanthosis nigricans skin exam [week 1 to 8 weeks]
7. Change in Triglyceride levels [week 1 to 8 weeks]
8. Change in Glucose Level [Week 1 to week 8 (mg/dl)]
9. Change in Insulin Level [Week 1 to week 8 (UIU/mL)]
