Şekerleri Kalorisiz Tatlandırıcılar veya Su ile Değiştirme Stratejileri (STOP Sugars NOW) Çalışması

Sade dilde özet

Bu çalışma, şekerli içeceklerin (sugar-sweetened beverage) yerine kalorisiz tatlandırıcılı içecekler (non-nutritive sweetened beverages) veya su konulmasının etkilerini karşılaştırmaktadır. Çalışmaya, düzenli olarak şekerli içecek tüketen, fazla kilolu veya obez, 18-75 yaş arası sağlıklı yetişkinler katılmıştır. Çalışma Faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz dışı

Durum

Tamamlandı

Sponsor

University of Toronto

Müdahale

Sugar-sweetened beverage (SSB), Non-nutritive sweetened beverages (NSB), Water

Başlangıç

31.05.2018

Tahmini bitiş

15.10.2020

Ülkeler

Canada

İlgili genler

Merkezler

• Toronto, Canada

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Healthy, adult (age, 18-75 years) men and non-pregnant women;
* Overweight or obese (BMI \> 23 kg/m2 for Asian individuals and \> 25 kg/m2 other individuals);
* High waist circumference (\> 94 cm in men, \> 80 cm in women in Europid, Sub-Saharan African, Eastern Mediterranean, and Middle Eastern individuals; \> 90 cm in men and \> 80 cm in women for South Asian, Chinese, Japanese, and South and Central American individuals);
* Currently report drinking SSBs regularly (≥ 1 serving daily);
* Have a primary care physician;
* Nonsmoker;
* Free of any diseases or illnesses;
* Not regularly taking any medications that have a clinically relevant effect on the primary outcomes, as deemed inappropriate by investigators

Exclusion Criteria:

* Age \< 18 or \> 75 years;
* BMI \< 23 kg/m2 for Asian individuals and \< 25 kg/m2 other individuals;
* Waist circumference \< 94cm in men, \< 80cm in women in Europid, Sub-Saharan African, Eastern Mediterranean, and Middle Eastern individuals; \< 90cm in men and \< 80 cm in women for South Asian, Chinese, Japanese, and South and Central American individuals;
* Not regularly drinking SSBs (≥1 serving per day);
* Pregnant or breast feeding females, or women planning on becoming pregnant throughout study duration;
* Regular medication use that have a clinically relevant effect on the primary outcomes, as deemed inappropriate by investigators
* Antibiotic use in the last 3 months;
* Complementary or alternative medicine (CAM) use as deemed inappropriate by investigators;
* Self-reported diabetes;
* Self-reported uncontrolled hypertension (or systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg \[26\]);
* Self-reported polycystic ovarian syndrome;
* Self-reported cardiovascular disease;
* Self-reported gastrointestinal disease;
* Previous bariatric surgery;
* Self-reported liver disease;
* Self-reported uncontrolled hyperthyroidism or hypothyroidism;
* Self-reported kidney disease;
* Self-reported chronic infection;
* Self-reported lung disease;
* Self-reported cancer/malignancy;
* Self-reported schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, and dissociative disorders;
* Major surgery in the last 6 months;
* Other major illness or health-related incidence within the last 6 months;
* Smoker;
* Regular recreational drug users;
* Heavy alcohol use (\> 3 drinks/day);
* Do not have a primary care physician;
* Participation in any trials within the last 6 months or for the duration of this study;
* Individuals planning on making dietary or physical activity changes throughout study duration;
* If participating in MRI portion of study: any condition or circumstance which would prevent the participant from having an MRI (e.g. having prostheses or metal implants, tattoos, or claustrophobia)