Diet for the Maintenance of Weight Loss and Metabolic Health in Obese Postmenopausal Women
NCT ID: NCT04136093
Last Updated: 2020-04-09
Study Results
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Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-02-29
2022-09-30
Brief Summary
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Detailed Description
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* Phase I lasting eight weeks (weeks 1-8). All participants will be introduced to a weight loss intervention with a daily energy deficit of 700 kcal per day. During this phase, changes in body weight and body composition (DEXA) and waist circumference will be measured every four weeks. Moreover, at each control visit, compliance with the prescribed diets will be measured by three-day food records. Moreover, the physical activity level will be done. Before and after weight loss phase changes in lipid and non-lipid parameters as well as eating behavior will be measured.
* Participants who will loss ≥10% initial body weight will be randomly assigned to phase II of the study (weight loss maintenance intervention). This phase will be lasting 24 weeks (weeks 9-32). Participants will receive the MED (n = 50) or DASH diet (n = 50). The control group (n = 50) will receive oral dietary recommendations based on the Harvard model "Healthy Eating Plate". During this phase, changes in body weight, body composition, and waist circumference will be measured every four weeks. Moreover, at each control visit, compliance with the prescribed diets will be measured by three-day food records. Moreover, the physical activity level will be done. Before and after weight loss phase changes in lipid and non-lipid parameters as well as valid markers of whole-grain wheat/rye and faty acids intake and eating behavior will be measured.
* After this 32 weeks period will be finished, the participants will be discharged to the community with no contact from study personnel for 20 weeks, until follow-up at 52 weeks study (Phase III - weeks 33 - 52). After this time changes in body weight, body composition and waist circumference will be measured. Moreover, the physical activity level will be done again and changes in lipid and non-lipid parameters, as well as valid markers of intake and eating behavior, will be measured.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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the MED
The 50 postmenopausal women who in phase I will lose ≥10% of initial body weight will be randomly assigned to the MED group
the MED
The MED diet will be composed of the basis food items traditional for the Mediterranean region i.e. olive oil, nuts, vegetables, fruits, and fish and this diet will be given an ad libitum approach. The MED diet will be giving a higher proportion of fat, at least 40% of the total energy, with 20% of the total energy from MUFAs, and less proportion of carbohydrates. To ensure the assumed supply of MUFAs and polyunsaturated fatty acids (PUFAs), the participants will be asked to daily intake 60 g (6 spoons) of extra virgin olive oil and 30 g (6 pieces) walnuts.
the DASH
The 50 postmenopausal women who in phase I will lose ≥10% of initial body weight will be randomly assigned to the DASH group
the DASH
The DASH diet will be giving a higher proportion of carbohydrates, at least 60% of total energy and less fat. The DASH diet will be composed wholegrain cereal products, fruit, vegetables, low-fat dairy products, fish, seafood, poultry, beans, seeds and nuts and will be recommending eating of the traditional polish food items for example oatmeal, rye bread, barley groats, apples, plums, etc. and reducing the supply of salt, sweets, sugars, fats especially saturated fats and red meat. In our study, the DASH diet will be given an ad libitum approach. The sufficient supply of carbohydrates and β glucans in the DASH diet will be ensured by daily consumption at least 50g oatmeal and 50g of barley groats.
The control group
The 50 postmenopausal women who in phase I will lose ≥10% of initial body weight will be randomly assigned to the control group.
Control diet
The control group will only receive oral dietary recommendations based on the Harvard model "Healthy Eating Plate", that recommend to eat a half of plate of vegetables and fruit, a quarter of plate of whole grains products, and a quarter of plate of protein products for one meal.
Interventions
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the MED
The MED diet will be composed of the basis food items traditional for the Mediterranean region i.e. olive oil, nuts, vegetables, fruits, and fish and this diet will be given an ad libitum approach. The MED diet will be giving a higher proportion of fat, at least 40% of the total energy, with 20% of the total energy from MUFAs, and less proportion of carbohydrates. To ensure the assumed supply of MUFAs and polyunsaturated fatty acids (PUFAs), the participants will be asked to daily intake 60 g (6 spoons) of extra virgin olive oil and 30 g (6 pieces) walnuts.
the DASH
The DASH diet will be giving a higher proportion of carbohydrates, at least 60% of total energy and less fat. The DASH diet will be composed wholegrain cereal products, fruit, vegetables, low-fat dairy products, fish, seafood, poultry, beans, seeds and nuts and will be recommending eating of the traditional polish food items for example oatmeal, rye bread, barley groats, apples, plums, etc. and reducing the supply of salt, sweets, sugars, fats especially saturated fats and red meat. In our study, the DASH diet will be given an ad libitum approach. The sufficient supply of carbohydrates and β glucans in the DASH diet will be ensured by daily consumption at least 50g oatmeal and 50g of barley groats.
Control diet
The control group will only receive oral dietary recommendations based on the Harvard model "Healthy Eating Plate", that recommend to eat a half of plate of vegetables and fruit, a quarter of plate of whole grains products, and a quarter of plate of protein products for one meal.
Eligibility Criteria
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Inclusion Criteria
* with central obesity waist circumference (WC) ≥ 80 cm
* with low physical activity (PAL = 1,40);
* who wished to lose weight and weight loss maintenance;
* and have at least one other criterion of metabolic syndrome increased systolic blood pressure ≥ 130 mm Hg or high blood pressure diastolic ≥ 85 mm Hg or ongoing treatment of previously diagnosed hypertension, increased serum triglyceride levels above \>150 mg/dl (1.7 mmol/l) or ongoing therapy hypertriglyceridemia, decreased HDL cholesterol below than \<50 mg/dl (1.3 mmol/l), and fasting blood glucose \> 100 mg/dl (5.6 mmol / l) or ongoing treatment of previously diagnosed type 2 diabetes.
Exclusion Criteria
* hypercortisolism, Cushing's syndrome;
* kidney diseases;
* type 1 diabetes;
* asthma treated with oral and injectable steroids;
* cancers; mental disorders;
* New York Heart Association (NYHA) Class III heart failure;
* as well as any drug is known to influence liver function;
* endocrine disorders;
* hormonal replacement therapy;
* significant weight change in the six months prior to the current study;
* impaired absorption of nutrients (celiac disease, inflammatory bowel disease);
* intolerance or food allergy to key components of the intervention diets;
* smoking
* excessive alcohol consumption (consumption of more than 2 alcohol units per day - one alcohol unit equals one bottle of beer (340 g) or one glass of wine (140 g) or one glass of spirits (42.5 g of 40% spirit).
50 Years
65 Years
FEMALE
Yes
Sponsors
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Poznan University of Life Sciences
OTHER
Responsible Party
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Lidia Małczak
Principal Investigator
Principal Investigators
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Lidia Małczak, MSc
Role: PRINCIPAL_INVESTIGATOR
Poznań University of Life Sciences
Locations
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Poznan University of Life Science
Poznan, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Bajerska J, Chmurzynska A, Muzsik A, Krzyzanowska P, Madry E, Malinowska AM, Walkowiak J. Weight loss and metabolic health effects from energy-restricted Mediterranean and Central-European diets in postmenopausal women: A randomized controlled trial. Sci Rep. 2018 Jul 24;8(1):11170. doi: 10.1038/s41598-018-29495-3.
Beavers DP, Beavers KM, Lyles MF, Nicklas BJ. Cardiometabolic risk after weight loss and subsequent weight regain in overweight and obese postmenopausal women. J Gerontol A Biol Sci Med Sci. 2013 Jun;68(6):691-8. doi: 10.1093/gerona/gls236. Epub 2012 Nov 26.
Beunza JJ, Toledo E, Hu FB, Bes-Rastrollo M, Serrano-Martinez M, Sanchez-Villegas A, Martinez JA, Martinez-Gonzalez MA. Adherence to the Mediterranean diet, long-term weight change, and incident overweight or obesity: the Seguimiento Universidad de Navarra (SUN) cohort. Am J Clin Nutr. 2010 Dec;92(6):1484-93. doi: 10.3945/ajcn.2010.29764. Epub 2010 Oct 20.
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FOLCH J, LEES M, SLOANE STANLEY GH. A simple method for the isolation and purification of total lipides from animal tissues. J Biol Chem. 1957 May;226(1):497-509. No abstract available.
Gibson AA, Sainsbury A. Strategies to Improve Adherence to Dietary Weight Loss Interventions in Research and Real-World Settings. Behav Sci (Basel). 2017 Jul 11;7(3):44. doi: 10.3390/bs7030044.
Hedrick VE, Dietrich AM, Estabrooks PA, Savla J, Serrano E, Davy BM. Dietary biomarkers: advances, limitations and future directions. Nutr J. 2012 Dec 14;11:109. doi: 10.1186/1475-2891-11-109.
Hernaez A, Castaner O, Elosua R, Pinto X, Estruch R, Salas-Salvado J, Corella D, Aros F, Serra-Majem L, Fiol M, Ortega-Calvo M, Ros E, Martinez-Gonzalez MA, de la Torre R, Lopez-Sabater MC, Fito M. Mediterranean Diet Improves High-Density Lipoprotein Function in High-Cardiovascular-Risk Individuals: A Randomized Controlled Trial. Circulation. 2017 Feb 14;135(7):633-643. doi: 10.1161/CIRCULATIONAHA.116.023712.
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Other Identifiers
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445446
Identifier Type: -
Identifier Source: org_study_id
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