Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome
Expectancy, Self-Efficacy and Outcomes in Metabolic Syndrome
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health and Science University General Clinical Research Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Sham-komparator: 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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Annen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Cholesterol
Tidsramme: baseline (Week 1) and outcome (Week 12)
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baseline (Week 1) and outcome (Week 12)
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insulin function
Tidsramme: baseline (Week 1) and outcome (Week 12)
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baseline (Week 1) and outcome (Week 12)
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weight loss
Tidsramme: baseline (Week 1) and outcome (Week 12)
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baseline (Week 1) and outcome (Week 12)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Cortisol levels
Tidsramme: baseline (Week 1) and outcome (Week 12)
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baseline (Week 1) and outcome (Week 12)
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- U19AT002656 (U.S. NIH-stipend/kontrakt)
- U19AT002656-03 (U.S. NIH-stipend/kontrakt)
- U19AT002656-02 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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