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 |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Laval University |
Barrett-Connor EL. Obesity, atherosclerosis, and coronary artery disease. Ann Intern Med. 1985 Dec;103(6 ( Pt 2)):1010-9. doi: 10.7326/0003-4819-103-6-1010. — View Citation
Bray G, Bouchard C, James W. Handbook of obesity. United States of America: Marcel Dekker, Inc.; 1998
Burnham KP, Anderson DR. Model Selection and Inference. A Pratical Information-Theoretic Approach. Springer; 1998: Chapters 2.2, 2.4, pp43-48, pp51-54.
Couillard C, Bergeron N, Prud'homme D, Bergeron J, Tremblay A, Bouchard C, Mauriege P, Despres JP. Postprandial triglyceride response in visceral obesity in men. Diabetes. 1998 Jun;47(6):953-60. doi: 10.2337/diabetes.47.6.953. — View Citation
Despres JP, Couillard C, Gagnon J, Bergeron J, Leon AS, Rao DC, Skinner JS, Wilmore JH, Bouchard C. Race, visceral adipose tissue, plasma lipids, and lipoprotein lipase activity in men and women: the Health, Risk Factors, Exercise Training, and Genetics (HERITAGE) family study. Arterioscler Thromb Vasc Biol. 2000 Aug;20(8):1932-8. doi: 10.1161/01.atv.20.8.1932. — View Citation
Despres JP, Moorjani S, Ferland M, Tremblay A, Lupien PJ, Nadeau A, Pinault S, Theriault G, Bouchard C. Adipose tissue distribution and plasma lipoprotein levels in obese women. Importance of intra-abdominal fat. Arteriosclerosis. 1989 Mar-Apr;9(2):203-10. doi: 10.1161/01.atv.9.2.203. — View Citation
Despres JP, Nadeau A, Tremblay A, Ferland M, Moorjani S, Lupien PJ, Theriault G, Pinault S, Bouchard C. Role of deep abdominal fat in the association between regional adipose tissue distribution and glucose tolerance in obese women. Diabetes. 1989 Mar;38(3):304-9. doi: 10.2337/diab.38.3.304. — View Citation
Despres JP. Lipoprotein metabolism in visceral obesity. Int J Obes. 1991 Sep;15 Suppl 2:45-52. No abstract available. — View Citation
Després JP. Obesity and lipid metabolism: relevance of body fat distribution. Curr Opin Lipidol. 1991;2:5-15.
Despres JP. The insulin resistance-dyslipidemia syndrome: the most prevalent cause of coronary artery disease? CMAJ. 1993 Apr 15;148(8):1339-40. No abstract available. — View Citation
Després JP. Visceral obesity: A component of the insulin resistance-dyslipidemic syndrome. Can J Cardiol. 1994;10:17B-22B.
Doucet E, Imbeault P, Almeras N, Tremblay A. Physical activity and low-fat diet: is it enough to maintain weight stability in the reduced-obese individual following weight loss by drug therapy and energy restriction? Obes Res. 1999 Jul;7(4):323-33. doi: 10.1002/j.1550-8528.1999.tb00415.x. — View Citation
Doucet E, St-Pierre S, Almeras N, Imbeault P, Mauriege P, Pascot A, Despres JP, Tremblay A. Reduction of visceral adipose tissue during weight loss. Eur J Clin Nutr. 2002 Apr;56(4):297-304. doi: 10.1038/sj.ejcn.1601334. — View Citation
Hubert HB, Feinleib M, McNamara PM, Castelli WP. Obesity as an independent risk factor for cardiovascular disease: a 26-year follow-up of participants in the Framingham Heart Study. Circulation. 1983 May;67(5):968-77. doi: 10.1161/01.cir.67.5.968. — View Citation
Kissebah AH, Freedman DS, Peiris AN. Health risks of obesity. Med Clin North Am. 1989 Jan;73(1):111-38. doi: 10.1016/s0025-7125(16)30695-2. — View Citation
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512. — View Citation
Krauss RM, Eckel RH, Howard B, Appel LJ, Daniels SR, Deckelbaum RJ, Erdman JW Jr, Kris-Etherton P, Goldberg IJ, Kotchen TA, Lichtenstein AH, Mitch WE, Mullis R, Robinson K, Wylie-Rosett J, St Jeor S, Suttie J, Tribble DL, Bazzarre TL. AHA Dietary Guidelines: revision 2000: A statement for healthcare professionals from the Nutrition Committee of the American Heart Association. Circulation. 2000 Oct 31;102(18):2284-99. doi: 10.1161/01.cir.102.18.2284. No abstract available. — View Citation
Lemieux I, Pascot A, Prud'homme D, Almeras N, Bogaty P, Nadeau A, Bergeron J, Despres JP. Elevated C-reactive protein: another component of the atherothrombotic profile of abdominal obesity. Arterioscler Thromb Vasc Biol. 2001 Jun;21(6):961-7. doi: 10.1161/01.atv.21.6.961. — View Citation
Lemieux S, Despres JP, Moorjani S, Nadeau A, Theriault G, Prud'homme D, Tremblay A, Bouchard C, Lupien PJ. Are gender differences in cardiovascular disease risk factors explained by the level of visceral adipose tissue? Diabetologia. 1994 Aug;37(8):757-64. doi: 10.1007/BF00404332. — View Citation
Lemieux S, Despres JP. Metabolic complications of visceral obesity: contribution to the aetiology of type 2 diabetes and implications for prevention and treatment. Diabete Metab. 1994 Jul-Aug;20(4):375-93. No abstract available. — View Citation
Manson JE, Colditz GA, Stampfer MJ, Willett WC, Rosner B, Monson RR, Speizer FE, Hennekens CH. A prospective study of obesity and risk of coronary heart disease in women. N Engl J Med. 1990 Mar 29;322(13):882-9. doi: 10.1056/NEJM199003293221303. — View Citation
National Institutes of Health. The practical guide. Identification, evaluation, and treatment of overweight and obesity in adults. National Heart, Lung, and Blood Institute and North American Association for the Study of Obesity; October 2000:1-77
Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253. — View Citation
Pare A, Dumont M, Lemieux I, Brochu M, Almeras N, Lemieux S, Prud'homme D, Despres JP. Is the relationship between adipose tissue and waist girth altered by weight loss in obese men? Obes Res. 2001 Sep;9(9):526-34. doi: 10.1038/oby.2001.69. — View Citation
Pascot A, Lemieux I, Prud'homme D, Tremblay A, Nadeau A, Couillard C, Bergeron J, Lamarche B, Despres JP. Reduced HDL particle size as an additional feature of the atherogenic dyslipidemia of abdominal obesity. J Lipid Res. 2001 Dec;42(12):2007-14. — View Citation
Pouliot MC, Despres JP, Nadeau A, Moorjani S, Prud'Homme D, Lupien PJ, Tremblay A, Bouchard C. Visceral obesity in men. Associations with glucose tolerance, plasma insulin, and lipoprotein levels. Diabetes. 1992 Jul;41(7):826-34. doi: 10.2337/diab.41.7.826. — View Citation
Tchernof A, Labrie F, Belanger A, Prud'homme D, Bouchard C, Tremblay A, Nadeau A, Despres JP. Androstane-3alpha,17beta-diol glucuronide as a steroid correlate of visceral obesity in men. J Clin Endocrinol Metab. 1997 May;82(5):1528-34. doi: 10.1210/jcem.82.5.3924. — View Citation
Tchernof A, Lamarche B, Prud'Homme D, Nadeau A, Moorjani S, Labrie F, Lupien PJ, Despres JP. The dense LDL phenotype. Association with plasma lipoprotein levels, visceral obesity, and hyperinsulinemia in men. Diabetes Care. 1996 Jun;19(6):629-37. doi: 10.2337/diacare.19.6.629. — View Citation
Tremblay A, Despres JP, Maheux J, Pouliot MC, Nadeau A, Moorjani S, Lupien PJ, Bouchard C. Normalization of the metabolic profile in obese women by exercise and a low fat diet. Med Sci Sports Exerc. 1991 Dec;23(12):1326-31. — View Citation
Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801. — View Citation
* 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06111040 -
Nurturing Needs Study: Parenting Food Motivated Children
|
N/A | |
Completed |
NCT06299072 -
A Cross-sectional Online Survey Among Saudi Arabian Population in the Age Group 18-40 Years to Assess Whole Grain (WG) Awareness, Consumption Levels, and Dietary Habits Around Breakfast
|
||
Recruiting |
NCT05863559 -
Super Chef - an Online Program Promoting the Mediterranean Dietary Pattern to Lower Income Families
|
N/A | |
Active, not recruiting |
NCT04583683 -
Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities
|
N/A | |
Not yet recruiting |
NCT05783141 -
Prebiotic Effects in Healthy Toddlers
|
N/A | |
Not yet recruiting |
NCT05934968 -
Mad Dog Cooking Class Series: Effects on Dietary Self-efficacy, Eating Behaviors and Health Outcomes
|
N/A | |
Active, not recruiting |
NCT05544461 -
Piloting a Web-based Personalised Nutrition App (eNutri) With UK University Students
|
N/A | |
Active, not recruiting |
NCT04991142 -
Models of Nutrition From Continuous Glucose Monitors
|
||
Recruiting |
NCT04946448 -
COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
|
N/A | |
Not yet recruiting |
NCT06464497 -
Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
|
N/A | |
Terminated |
NCT04067362 -
Chicory Fiber Effect on Satiety and GI Tolerance
|
N/A | |
Completed |
NCT04084028 -
Cooking as a Health Behavior in College Students
|
N/A | |
Recruiting |
NCT05512247 -
Hearty Meals for Mom- Pilot Study of Meal Delivery for Cardiometabolic Health During Pregnancy
|
N/A | |
Recruiting |
NCT06145009 -
Time Restricted Eating, Eating Behaviors, and Cardiometabolic Risk in Emerging Adult Women
|
N/A | |
Recruiting |
NCT06022302 -
Effects of Changing Intestinal Transit Time on Gut Microbial Composition and Metabolism
|
N/A | |
Completed |
NCT05173376 -
SEP and the Impact of Portion Size on Daily Energy Intake
|
N/A | |
Recruiting |
NCT04374747 -
Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk
|
N/A | |
Recruiting |
NCT04876053 -
Home Food Delivery for Diabetes Management in Patients of Rural Clinics
|
N/A | |
Not yet recruiting |
NCT06298253 -
Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2
|
N/A | |
Not yet recruiting |
NCT05566587 -
Designing a Personalized Diet to Reduce the Risk of Crohn's Disease Onset
|
N/A |