Diet, Healthy Clinical Trial
— SYNERGIEOfficial title:
Abdominal Obesity as a Therapeutic Target: Long-term Benefits of Abdominal Fat Loss and Weight Stabilization in High-risk Abdominally Obese Dyslipidemic Patients With the Features of the Metabolic Syndrome (SYNERGIE Study)
Verified date | November 2023 |
Source | Laval University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this clinical trial is to verify whether the beneficial effects of weight loss on visceral fat measured by computed tomography and metabolic risk factors for coronary heart disease are maintained once high-risk patients without symptoms and with visceral obesity and dyslipidemia are stabilized and maintained for two additional years after a one-year weight loss (5-10%) program. Before entering the study, after the one-year intervention program, and after the 2-year maintenance period, participants will be asked to take part in multiple assessments: fasting lipid profile and apolipoproteins measurements, oral glucose tolerance test, anthropometric measurements, computed tomography, dual-energy X-ray absorptiometry, oral lipid tolerance test, measurements of inflammatory markers, physical activity and dietary diaries, cardiorespiratory fitness assessed by a submaximal treadmill test, and measurements of resting and exercise blood pressure. During the one-year intervention, participants will be closely monitored by the study's dietitians and kinesiologists to achieve the target weight loss. Dieticians will not recommend a daily energy deficit greater than 500 calories and will focus on foods rather than the nutrient composition of the diet. Participants will have access to the dieticians at all time, and appointments every two months will be required during the first year. Regarding physical activity, kinesiologists will supervise the exercise prescription which will aim at 160 minutes per week of moderate-intensity aerobic-exercise. The physical activity prescription will be adjusted by the kinesiologist according to the participant's preferences and habits. The investigators hypothesize that there will be a worsening in some features of the metabolic syndrome over the two-year weight maintenance period. However, it is suggested the greater the weight loss during the intervention, the less marked the deterioration will be. Finally, the investigators put forward that even in the absence of weight loss during the intervention, the lifestyle modification program will prevent visceral fat accumulation expected to be observed over the two-year maintenance period in the control group maintaining their usual behaviour.
Status | Completed |
Enrollment | 186 |
Est. completion date | December 15, 2008 |
Est. primary completion date | December 15, 2008 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 30 Years to 65 Years |
Eligibility | Inclusion Criteria: - Body mass index between 25 kilograms/meters² and 40 kilograms/meters² - Waist circumference = 90 centimeters and triglycerides = 2.0 milimoles/liter or HDL < 1.03 milimoles/liter Exclusion Criteria: - Pharmacological treatment for hypertension, dyslipidemias, type 2 diabetes, coronary heart disease, or cardiovascular disease - Type 2 diabetes diagnosis at baseline screening - Use of weight loss medication in the past 6 months |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Laval University |
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* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in body weight following the lifestyle intervention and the maintenance period using dual-energy x-ray absorptiometry | Changes in body weight in kilograms | After the 1-year intervention and at 3 years after the beginning of the study | |
Primary | Changes in visceral adipose tissue area following the lifestyle intervention and the maintenance period using computed tomography | Changes in visceral adipose tissue area in centimeters² | After the 1-year intervention and at 3 years after the beginning of the study | |
Primary | Changes in visceral adipose tissue volume following the lifestyle intervention and the maintenance period using computed tomography | Changes in visceral adipose tissue volume in centimeters³ | After the 1-year intervention and at 3 years after the beginning of the study | |
Primary | Changes in waist circumference following the lifestyle intervention and the maintenance period using a standardized measuring tape | Changes in waist circumference in centimeters | After the 1-year intervention and at 3 years after the beginning of the study | |
Primary | Changes in subcutaneous adipose tissue area following the lifestyle intervention and the maintenance period | Changes in subcutaneous adipose tissue area in centimeters² | After the 1-year intervention and at 3 years after the beginning of the study | |
Primary | Changes in subcutaneous adipose tissue volume following the lifestyle intervention and the maintenance period | Changes in subcutaneous adipose tissue volume in centimeters³ | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in systolic blood pressure following the lifestyle intervention and the maintenance period | Changes in systolic blood pressure in mercury millimeters | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in diastolic blood pressure following the lifestyle intervention and the maintenance period | Changes in diastolic blood pressure in mercury millimeters | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in plasma triglycerides following the lifestyle intervention and the maintenance period | Changes in plasma triglycerides in millimoles per liter | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in fasting total cholesterol following the lifestyle intervention and the maintenance period | Changes in fasting total cholesterol in millimoles per liter | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in fasting HDL cholesterol following the lifestyle intervention and the maintenance period | Changes in fasting HDL cholesterol in millimoles per liter | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in fasting LDL cholesterol following the lifestyle intervention and the maintenance period | Changes in fasting LDL cholesterol in millimoles per liter | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in fasting apolipoproteinA1 following the lifestyle intervention and the maintenance period | Changes in fasting ApolipoproteinA1 in grams per liter | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in fasting apolipoproteinB following the lifestyle intervention and the maintenance period | Changes in fasting ApolipoproteinB in grams per liter | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in fasting glucose following the lifestyle intervention and the maintenance period | Changes in fasting glucose in millimoles per liter | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in fasting insulin following the lifestyle intervention and the maintenance period | Changes in fasting insulin in picomoles per liter | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in glucose area under the curve after an oral glucose tolerance test following the lifestyle intervention and the maintenance period | Changes in glucose area under the curve in millimoles per liter * 180 minutes | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in insulin area under the curve after an oral glucose tolerance test following the lifestyle intervention and the maintenance period | Changes in insulin area under the curve in picomoles per liter * 180 minutes | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in insulin resistance following the lifestyle intervention and the maintenance period | Changes in insulin resistance assessed by the homeostasis model assessment of insulin resistance (HOMA-IR) | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in cardiorespiratory fitness following the lifestyle intervention and the maintenance period | Changes in Metabolic Equivalent of Tasks (METs) reach at a heart rate of 150 beats per minutes | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in physical activity behaviours following the lifestyle intervention and the maintenance period | Changes in daily physical activity practice according to the three-day Bouchard physical activity journal. Days in the journal were divided into 15-min periods and energy expenditure was qualified on a scale of 1 to 9 for each period. A higher number indicates a greater energy expenditure for that period. | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in the number of steps per day following the lifestyle intervention and the maintenance period | Changes in the number of steps per day with a pedometer | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in total energy intake following the lifestyle intervention and the maintenance period | Changes in total energy intake in kilocalories | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in the macronutrient composition of the diet following the lifestyle intervention and the maintenance period | Changes in the macronutrient composition of the diet in percentage | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in fat mass following the lifestyle intervention and the maintenance period | Changes in fat mass in kilograms | After the 1-year intervention and at 3 years after the beginning of the study | |
Secondary | Changes in fat-free mass following the lifestyle intervention and the maintenance period | Changes in fat-free mass in kilograms | After the 1-year intervention and at 3 years after the beginning of the study |
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