Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome
Expectancy, Self-Efficacy and Outcomes in Metabolic Syndrome
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Metabolic syndrome is a serious condition involving abnormal glucose and lipid metabolism and obesity; these symptoms are associated with a two- to fourfold increased risk for cardiovascular disease and diabetes. The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.
This study will last 12 weeks. Participants will be randomly assigned to one of three arms. Participants in Arm 1 will receive the supplement; participants in Arm 2 will have a 50% chance of receiving either the supplement or placebo; participants in Arm 3 will receive placebo. Participants will take their assigned pills 3 times daily for 12 weeks. A follow-up visit will occur at the end of the 12 weeks; there will be a debriefing visit shortly after the follow-up visit. Participants in all 3 arms will receive weekly education and counseling sessions on healthy lifestyle changes to encourage weight loss. Blood collection will occur at study start and at the end of 12 weeks for assessment of fasting blood glucose, insulin, cholesterol, and levels of certain hormones. Participants will also be asked to complete questionnaires at study entry and at Week 12; the questionnaires will assess depression, stress, self-absorption, optimism, food cravings, hunger, the degree to which participants seek pleasure from activities, and participants' thoughts about their ability to make behavioral changes.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- Oregon Health and Science University General Clinical Research Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Body mass index (BMI) between 30 and 45
- Live in the Portland, Oregon metropolitan area
- Willing and able to complete a 12-week weight loss program
- Meet at least 3 of the following 5 criteria: 1) waist circumference greater than 40 inches for men and 35 inches for women; 2) fasting triglycerides higher than 150 mg/dl; 3) high density lipoprotein (HDL) lower than 40 mg/dl for men and 50 mg/dl for women; 4) systolic blood pressure (BP) of 130 mmHg or higher or diastolic BP of 85 mmHg or higher; 5) fasting glucose of 100 mg/dl or higher
Exclusion Criteria:
- Any medications, including dietary supplements, that could interfere with the study
- Medical conditions contraindicating a diet and exercise weight loss program
- History of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic cardiovascular disease
- Current diagnosis of cancer
- Hospitalization for a psychiatric condition within 12 months prior to study entry
- Weight loss medications within 6 months prior to study entry
- Change in body weight greater than 5% within 6 months prior to study entry
- Consumption of more than 21 alcoholic drinks per week
- Current participation in another clinical trial OR living in the same household with another participant in this study
- Currently exercising for more than 30 minutes, 3 times per week
- Fasting blood glucose higher than 125 mg/dl
- BP higher than 145/90
- Triglycerides higher than 500 mg/dl
- Training as a health care provider or health scientist
- Pregnancy or breastfeeding
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 1
Has 100% expectation of receiving supplement
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The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.
Hour and a half weight loss education session weekly for 12 weeks.
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Comparatore fittizio: 2
Has 50% expectation of receiving supplement
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The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.
Hour and a half weight loss education session weekly for 12 weeks.
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Altro: 3
Has 0% expectation of receiving supplement.
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Hour and a half weight loss education session weekly for 12 weeks.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Cholesterol
Lasso di tempo: baseline (Week 1) and outcome (Week 12)
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baseline (Week 1) and outcome (Week 12)
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insulin function
Lasso di tempo: baseline (Week 1) and outcome (Week 12)
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baseline (Week 1) and outcome (Week 12)
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weight loss
Lasso di tempo: baseline (Week 1) and outcome (Week 12)
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baseline (Week 1) and outcome (Week 12)
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Cortisol levels
Lasso di tempo: baseline (Week 1) and outcome (Week 12)
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baseline (Week 1) and outcome (Week 12)
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- U19AT002656 (Sovvenzione/contratto NIH degli Stati Uniti)
- U19AT002656-03 (Sovvenzione/contratto NIH degli Stati Uniti)
- U19AT002656-02 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Dietary supplement for weight loss
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Tufts UniversityCompletatoQualità della vita | Obesità | SovrappesoStati Uniti