Status:
COMPLETED
Sucralose and Glucose Metabolism in Young Healthy Adults
Lead Sponsor:
University of Ottawa
Conditions:
Glucose Intolerance
Glucose and Insulin Response
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
This study aimed to investigate the effects of a three-week consumption of sucralose-sweetened beverages (low-calorie sweetener) on postprandial glycemic responses in healthy adults, compared with sug...
Detailed Description
PRELIMINARY SESSION (duration of 2h15) : To determine eligibility, participants were asked to undergo a fasted in-person preliminary session during which the following measures were taken: height, we...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA included ages 18-35 y, body mass index (BMI) between 18.0 and 34.9 kg/m2, waist circumference \< 102cm (men) and \< 88cm (women) and a self-reported stable weight during the prior 6 months (+ or - 2kg) of beginning the study.
- Additional Considerations related to the menstrual cycle and the use of hormonal contraceptives : All women who participated in this study were premenopausal. Recognizing the crucial importance of including women in our study while ensuring the highest quality data, additional considerations were applied to meet inclusion criteria: Women using no form of hormonal contraception or using copper intrauterine device (IUD) required to report having a regular menstrual cycle to be included; Women using anovulants (birth control pills) were advised to take their daily anovulant continuously for a period of 28 days to ensure stable hormone levels throughout the study (informed consent was obtained). Oral contraceptives release a low and stable daily amount of progestins, which were reported to have minor or no effects on glycemic responses of pre-menopausal women in a recent meta-analysis38; Women using hormonal contraception such as hormonal IUD and subdermal contraceptive implant were included regardless of their menstrual cycle. Like anovulants, hormonal IUD release a low and stable amount of a progestin (levonorgestrel) into the uterus, therefore preventing periodic fluctuations in hormonal levels during the menstrual cycle. Since Levonorgestrel was included as one of the progestins in the aforementioned meta-analysis38, it was therefore assumed that HIUD would also not have a significant impact on glycemic responses, especially as its effect is local rather than systemic; Women using medroxyprogesterone acetate injections (Depo-Provera shot) were excluded given the pro-inflammatory effects associated with high doses of progestin; Women experiencing pregnancy or lactation were excluded.
- EXCLUSION CRITERIA consisted of prediabetes (fasting glucose ≥ 6.1 mmol/L), diabetes (fasting glucose ≥ 7.0 mmol/L), hypertension (\> 140/90 mmHg), personal medical history for dyslipidemias (including hypercholesterolemia and hypertriglyceridemia), and surgery for weight loss. In addition, individuals who smoke tobacco (including vaping), habitually ingest \>2 alcoholic beverages/day, use cannabis or cannabis-derived products \>1 time/month , exercise \>3.5 h/week at a level more vigorous than walking, or use thyroid, lipid-lowering, glucose-lowering, antihypertensive, antidepressant/antianxiety, antibiotics in the prior 3 months or weight-loss medications were excluded. Finally, individuals susceptible to exhibit clinically relevant levels of food cravings as indicated by a score \> 50 on the Food Cravings Questionnaire - Trait reduced (FCQ-T-r)36, were also excluded. FCQ-T-r (15 items) is a validated questionnaire37 that assesses four factors: (1) preoccupation with food (i.e., obsessive thought about food and eating), (2) loss of control (i.e., difficulty regulating eating behavior when exposed to food cues), (3) positive outcome expectancy (i.e., believing eating to be positively reinforcing), and (4) emotional craving (i.e., tending to crave food when experiencing negative emotion).
Exclusion
Key Trial Info
Start Date :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT07194772
Start Date
March 16 2022
End Date
June 12 2024
Last Update
September 26 2025
Active Locations (1)
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1
Behavioural and Metabolic Research Unit, School of Human Kinetics, Faculty of Health Sciences, University of Ottawa
Ottawa, Ontario, Canada, K1S 5S9