Metabolic SyndromeWELCOMENCT04136093
Diet for the Maintenance of Weight Loss and Metabolic Health in Obese Postmenopausal Women
A study testing the MED and the DASH in people with Metabolic Syndrome and Diet Modification, run by Poznan University of Life Sciences at 1 site in Poland.
Trial summary
The aim of the study will be comparing the effectiveness of two diets: moderate in fat with a high proportion of monounsaturated fatty acids (MUFAs) - the Mediterranean diet (MED) and 2) the low in fat and high in dietary fiber contents the dietary approaches to stop hypertension diet (DASH) on weight maintenance and… Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Diet Modification, Postmenopause
- What is being tested?
- the MED and the DASH
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 29 Feb 2020to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- postmenopausal women, with the absence of menses of over 12 months or serum follicle stimulating hormone > 30 IU/mL;
- 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.
Who cannot join
- thyroid disease (hypothyroidism, hyperthyroidism, thyroiditis);
- hypercortisolism, Cushing's syndrome;
- kidney diseases;
- type 1 diabetes;
- asthma treated with oral and injectable steroids;
- cancers; mental disorders;
Show all 15Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Life Science
Poznan, 60-624
Lidia Małczak, MSc, +48787656850, lidia.malczak@up.poznan.pl;
Joanna Bajerska, Prof., +48618466056, joanna.bajerska@up.poznan.pl
About this study
Official title: Defining the Optimal Dietary Strategy for the Maintenance of Weight Loss and mEtaboLiC Outcomes in Centrally Obese postMenopausal womEn (WELCOME Study).
The aim of the study will be comparing the effectiveness of two diets: moderate in fat with a high proportion of monounsaturated fatty acids (MUFAs) - the Mediterranean diet (MED) and 2) the low in fat and high in dietary fiber contents the dietary approaches to stop hypertension diet (DASH) on weight maintenance and cardiovascular risks following a recent body weight reduction in centrally obese postmenopausal women. The tested diets will be given ad libitum manner. Moreover, adherence to both prescribed weight-loss maintenance diets will be also evaluated by the plasma concentration of alkylresorcinols (AR) as a possible whole grain wheat/rye dietary biomarker and by the analysis of fatty acids profile in erythrocyte membranes as a dietary biomarker of a fatty acids consumption. The participants of this study will be 150 non-smoking, postmenopausal women with central obesity, who wished to lose weight and have at least one other criterion of metabolic syndrome. The intervention will include 3 phases: Phase I (weeks 1-8), weight loss dietary intervention with 700 kcal/d energy deficit, Phase II (week 9-32), weight loss maintenance intervention for those participants losing ≥10% initial body weight the MED or the DASH diet will be offered in a random manner. The control group will receive oral dietary recommendations based on the Harvard model "Healthy Eating Plate". After this 32 weeks period will be finished, the participants will be discharged to the community with no contact by study personnel, until the 52-weeks follow-up period (Phase III).
Read the detailed description
The treatment of obesity can present a challenge because of the difficulty in maintaining body weight loss beyond one year. The aim of the study will be comparing the effectiveness of two energy-unrestricted diets containing different amount of macronutrients: 1) moderate in fat with high amounts of MUFAs - the MED diet and 2) low in fat with high dietary fiber contents - the DASH diet, on maintenance of weight loss and metabolic outcomes following a recent weight loss in centrally obese postmenopausal women. Since the outcomes of dietary interventions may depend greatly on adherence to the diet, we will measure the plasma AR concentrations and fatty acids profile in red blood cells (RBC). Plasma AR concentrations is a valid marker of intake of whole-grain wheat/rye in the DASH diet and fatty acids concentration in RBC is a valid marker of fatty acids intake (especially MUFAs) in the MED diet. A total of 150 non-smoking, centrally obese, with at least one other criterion of metabolic syndrome postmenopausal women up to 65 old years will be qualified. This study will be divided into 3 phases:
- 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
- Metabolic Syndrome, Diet Modification, Postmenopause
- Being tested
- the MED, the DASH, Control diet
- Keywords
- Weight Loss Maintenance, Metabolic Disorders, Postmenopausal Women, Cardiometabolic Parameters, Diet Therapy, Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the MEDOther
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 DASHOther
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 dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| the MED | Experimental | The 50 postmenopausal women who in phase I will lose ≥10% of initial body weight will be randomly assigned to the MED group Receives: Other: the MED |
| the DASH | Experimental | The 50 postmenopausal women who in phase I will lose ≥10% of initial body weight will be randomly assigned to the DASH group Receives: Other: the DASH |
| The control group | Experimental | The 50 postmenopausal women who in phase I will lose ≥10% of initial body weight will be randomly assigned to the control group. Receives: Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight [kg]
Changes in body weight from 9 to 52 week of weight loss maintenance period
Measured: measurements will be taken after 8 weeks of weight loss diet (before weight loss maintenance period) and after 12, 16, 20, 24, 28, 32 and after 52 week of study.
Changes in waist circumferences (WC) [cm]
Changes in waist circumferences from 9 to 52 week of weight loss maintenance period.
Measured: measurements will be taken after 8 weeks weight loss diet (before weight loss maintenance period) and after 12, 16, 20, 24, 28, 32 and after 52 week of study.
Changes in fat mass [kg]
Changes in fat mass from 9 to 52 weeks of weight loss maintenance period.
Measured: measurements will be taken after 8 weeks weight loss diet (before weight loss maintenance period) and after 12, 16, 20, 24, 28, 32 and after 52 week of study.
Changes in HDL cholesterol [mg/dL]
Changes in HDL cholesterol from 9 to 52 week of weight loss maintenance period.
Measured: Examination will be taken after 8 weeks weight loss diet (before weight loss maintenance period) after 32 and also after 52 week of study.
changes in triglycerides (TG) [mg/dL]
Changes in TG from 9 to 52 week of weight loss maintenance period.
Measured: Examination will be taken after 8 weeks weight loss diet (before weight loss maintenance period) after 32 and also after 52 week of study.
changes in glucose (GLU)
Changes in GLU from 9 to 52 week of weight loss maintenance period.
Measured: Examination will be taken after 8 weeks weight loss diet (before weight loss maintenance period) after 32 and 52 week of study.
Changes in systolic blood pressure (SBP)
Changes in SBP from 9 to 52 week of weight loss maintenance period.
Measured: measurements will be taken after 8 weeks weight loss diet (before weight loss maintenance period) and after 12, 16, 20, 24, 28, 32 and also after 52 week of study.
Changes in diastolic blood pressure (DBP)
Changes in DBP from 9 to 52 weeks of weight loss maintenance period.
Measured: measurements will be taken after 8 weeks weight loss diet (before weight loss maintenance period) and after 12, 16, 20, 24, 28, 32 and also after 52 week of study.
Secondary outcomes (4)
Physical activity level (PAL)
The assessment of the PAL from 9 to 52 week weight loss maintenance period.
Measured: The assessment of the PA level will be done after 8 weeks of weight loss diet (before weight loss maintenance period) and after 32 and 52 week of study.
Eating behaviour (by measurement of dietary restraint, disinhibition and hunger)
The assessment of the eating behaviour from 9 to 52 week weight loss maintenance period.
Measured: The assessment of the eating behaviour will be done after 8 weeks of weight loss diet (before weight loss maintenance period), after 32 and also after 52 week of study.
Adherence to the prescribed diets (assessment of the plasma AR levels and concentration and fatty acids in red blood cells)
The assessment of the adherence from 9 to 32 weeks weight loss maintenance period.
Measured: The assessment of the adherence will be done after 12, 16, 20, 24, 28 and 32 week of study.
Dietary intake
The assessment of the dietary intake from 9 to 52 weeks weight loss maintenance period.
Measured: Each participant"s dietary records will be assessed after 12, 16, 20, 24, 28, and 32 and also after 52 week of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start29 Feb 2020
- Primary completionMay 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lidia Małczak, Poznan University of Life Sciences
- Investigators
- Lidia Małczak, MSc, Principal investigator, Poznań University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136093
- Sponsor's protocol ID
- 445446
- Acronym
- WELCOME
- Status last verified
- Apr 2020
- First submitted
- 21 Oct 2019
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30042488Beavers 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.
PubMed 23183902Beunza 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.
PubMed 20962161Elfhag K, Rossner S. Who succeeds in maintaining weight loss? A conceptual review of factors associated with weight loss maintenance and weight regain. Obes Rev. 2005 Feb;6(1):67-85. doi: 10.1111/j.1467-789X.2005.00170.x.
PubMed 15655039FOLCH 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.
PubMed 13428781Gibson 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.
PubMed 28696389Hedrick 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.
PubMed 23237668Hernaez 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.
PubMed 28193797Kozakowski J, Gietka-Czernel M, Leszczynska D, Majos A. Obesity in menopause - our negligence or an unfortunate inevitability? Prz Menopauzalny. 2017 Jun;16(2):61-65. doi: 10.5114/pm.2017.68594. Epub 2017 Jun 30.
PubMed 28721132Krishnan S, Cooper JA. Effect of dietary fatty acid composition on substrate utilization and body weight maintenance in humans. Eur J Nutr. 2014 Apr;53(3):691-710. doi: 10.1007/s00394-013-0638-z. Epub 2013 Dec 22.
PubMed 24363161Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, McManus K, Champagne CM, Bishop LM, Laranjo N, Leboff MS, Rood JC, de Jonge L, Greenway FL, Loria CM, Obarzanek E, Williamson DA. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med. 2009 Feb 26;360(9):859-73. doi: 10.1056/NEJMoa0804748.
PubMed 19246357Santoro N. The menopausal transition. Am J Med. 2005 Dec 19;118 Suppl 12B:8-13. doi: 10.1016/j.amjmed.2005.09.008.
PubMed 16414322Soeliman FA, Azadbakht L. Weight loss maintenance: A review on dietary related strategies. J Res Med Sci. 2014 Mar;19(3):268-75.
PubMed 24949037Stachowiak G, Pertynski T, Pertynska-Marczewska M. Metabolic disorders in menopause. Prz Menopauzalny. 2015 Mar;14(1):59-64. doi: 10.5114/pm.2015.50000. Epub 2015 Mar 25.
PubMed 26327890Thom G, Lean M. Is There an Optimal Diet for Weight Management and Metabolic Health? Gastroenterology. 2017 May;152(7):1739-1751. doi: 10.1053/j.gastro.2017.01.056. Epub 2017 Feb 15.
PubMed 28214525
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Optimal Dietary Strategy for the Maintenance of Weight Loss and mEtaboLiC Outcomes in Centrally Obese postMenopausal womEn (WELCOME Study).
- ClinicalTrials.gov ID
- NCT04136093
- Acronym / sponsor ID
- WELCOME / 445446
- Conditions
- Metabolic Syndrome, Diet Modification, Postmenopause
- Keywords
- Weight Loss Maintenance, Metabolic Disorders, Postmenopausal Women, Cardiometabolic Parameters, Diet Therapy, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 29 Feb 2020 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study will be comparing the effectiveness of two diets: moderate in fat with a high proportion of monounsaturated fatty acids (MUFAs) - the Mediterranean diet (MED) and 2) the low in fat and high in dietary fiber contents the dietary approaches to stop hypertension diet (DASH) on weight maintenance and cardiovascular risks following a recent body weight reduction in centrally obese postmenopausal women. The tested diets will be given ad libitum manner. Moreover, adherence to both prescribed weight-loss maintenance diets will be also evaluated by the plasma concentration of alkylresorcinols (AR) as a possible whole grain wheat/rye dietary biomarker and by the analysis of fatty acids profile in erythrocyte membranes as a dietary biomarker of a fatty acids consumption. The participants of this study will be 150 non-smoking, postmenopausal women with central obesity, who wished to lose weight and have at least one other criterion of metabolic syndrome. The intervention will include 3 phases: Phase I (weeks 1-8), weight loss dietary intervention with 700 kcal/d energy deficit, Phase II (week 9-32), weight loss maintenance intervention for those participants losing ≥10% initial body weight the MED or the DASH diet will be offered in a random manner. The control group will receive oral dietary recommendations based on the Harvard model "Healthy Eating Plate". After this 32 weeks period will be finished, the participants will be discharged to the community with no contact by study personnel, until the 52-weeks follow-up period (Phase III).
Detailed description
The treatment of obesity can present a challenge because of the difficulty in maintaining body weight loss beyond one year. The aim of the study will be comparing the effectiveness of two energy-unrestricted diets containing different amount of macronutrients: 1) moderate in fat with high amounts of MUFAs - the MED diet and 2) low in fat with high dietary fiber contents - the DASH diet, on maintenance of weight loss and metabolic outcomes following a recent weight loss in centrally obese postmenopausal women. Since the outcomes of dietary interventions may depend greatly on adherence to the diet, we will measure the plasma AR concentrations and fatty acids profile in red blood cells (RBC). Plasma AR concentrations is a valid marker of intake of whole-grain wheat/rye in the DASH diet and fatty acids concentration in RBC is a valid marker of fatty acids intake (especially MUFAs) in the MED diet. A total of 150 non-smoking, centrally obese, with at least one other criterion of metabolic syndrome postmenopausal women up to 65 old years will be qualified. This study will be divided into 3 phases:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the MED | Experimental | Other: the MEDThe 50 postmenopausal women who in phase I will lose ≥10% of initial body weight will be randomly assigned to the MED group |
| the DASH | Experimental | Other: the DASHThe 50 postmenopausal women who in phase I will lose ≥10% of initial body weight will be randomly assigned to the DASH group |
| The control group | Experimental | Other: Control dietThe 50 postmenopausal women who in phase I will lose ≥10% of initial body weight will be randomly assigned to the control group. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- postmenopausal women, with the absence of menses of over 12 months or serum follicle stimulating hormone > 30 IU/mL;
- 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.
Key exclusion criteria (15 listed)
- thyroid disease (hypothyroidism, hyperthyroidism, thyroiditis);
- hypercortisolism, Cushing's syndrome;
- kidney diseases;
- type 1 diabetes;
- asthma treated with oral and injectable steroids;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the MEDThe 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. | Other | the MED |
| the DASHThe 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. | Other | the DASH |
| Control dietThe 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. | Other | The control group |
Primary outcome
Changes in body weight [kg]
Time frame: measurements will be taken after 8 weeks of weight loss diet (before weight loss maintenance period) and after 12, 16, 20, 24, 28, 32 and after 52 week of study.
Changes in body weight from 9 to 52 week of weight loss maintenance period
Changes in waist circumferences (WC) [cm]
Time frame: measurements will be taken after 8 weeks weight loss diet (before weight loss maintenance period) and after 12, 16, 20, 24, 28, 32 and after 52 week of study.
Changes in waist circumferences from 9 to 52 week of weight loss maintenance period.
Changes in fat mass [kg]
Time frame: measurements will be taken after 8 weeks weight loss diet (before weight loss maintenance period) and after 12, 16, 20, 24, 28, 32 and after 52 week of study.
Changes in fat mass from 9 to 52 weeks of weight loss maintenance period.
Changes in HDL cholesterol [mg/dL]
Time frame: Examination will be taken after 8 weeks weight loss diet (before weight loss maintenance period) after 32 and also after 52 week of study.
Changes in HDL cholesterol from 9 to 52 week of weight loss maintenance period.
changes in triglycerides (TG) [mg/dL]
Time frame: Examination will be taken after 8 weeks weight loss diet (before weight loss maintenance period) after 32 and also after 52 week of study.
Changes in TG from 9 to 52 week of weight loss maintenance period.
changes in glucose (GLU)
Time frame: Examination will be taken after 8 weeks weight loss diet (before weight loss maintenance period) after 32 and 52 week of study.
Changes in GLU from 9 to 52 week of weight loss maintenance period.
Changes in systolic blood pressure (SBP)
Time frame: measurements will be taken after 8 weeks weight loss diet (before weight loss maintenance period) and after 12, 16, 20, 24, 28, 32 and also after 52 week of study.
Changes in SBP from 9 to 52 week of weight loss maintenance period.
Changes in diastolic blood pressure (DBP)
Time frame: measurements will be taken after 8 weeks weight loss diet (before weight loss maintenance period) and after 12, 16, 20, 24, 28, 32 and also after 52 week of study.
Changes in DBP from 9 to 52 weeks of weight loss maintenance period.
4 secondary outcomes
Physical activity level (PAL)
Time frame: The assessment of the PA level will be done after 8 weeks of weight loss diet (before weight loss maintenance period) and after 32 and 52 week of study.
Eating behaviour (by measurement of dietary restraint, disinhibition and hunger)
Time frame: The assessment of the eating behaviour will be done after 8 weeks of weight loss diet (before weight loss maintenance period), after 32 and also after 52 week of study.
Adherence to the prescribed diets (assessment of the plasma AR levels and concentration and fatty acids in red blood cells)
Time frame: The assessment of the adherence will be done after 12, 16, 20, 24, 28 and 32 week of study.
Dietary intake
Time frame: Each participant"s dietary records will be assessed after 12, 16, 20, 24, 28, and 32 and also after 52 week of study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Background: PubMed 30042488Bajerska 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.
- Background: PubMed 23183902Beavers 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.
- Background: PubMed 20962161Beunza 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.
- Background: PubMed 15655039Elfhag K, Rossner S. Who succeeds in maintaining weight loss? A conceptual review of factors associated with weight loss maintenance and weight regain. Obes Rev. 2005 Feb;6(1):67-85. doi: 10.1111/j.1467-789X.2005.00170.x.
- Background: PubMed 13428781FOLCH 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.
- Background: PubMed 28696389Gibson 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.
- Background: PubMed 23237668Hedrick 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.
- Background: PubMed 28193797Hernaez 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.
- Background: PubMed 28721132Kozakowski J, Gietka-Czernel M, Leszczynska D, Majos A. Obesity in menopause - our negligence or an unfortunate inevitability? Prz Menopauzalny. 2017 Jun;16(2):61-65. doi: 10.5114/pm.2017.68594. Epub 2017 Jun 30.
- Background: PubMed 24363161Krishnan S, Cooper JA. Effect of dietary fatty acid composition on substrate utilization and body weight maintenance in humans. Eur J Nutr. 2014 Apr;53(3):691-710. doi: 10.1007/s00394-013-0638-z. Epub 2013 Dec 22.
- Background: PubMed 19246357Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, McManus K, Champagne CM, Bishop LM, Laranjo N, Leboff MS, Rood JC, de Jonge L, Greenway FL, Loria CM, Obarzanek E, Williamson DA. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med. 2009 Feb 26;360(9):859-73. doi: 10.1056/NEJMoa0804748.
- Background: PubMed 16414322Santoro N. The menopausal transition. Am J Med. 2005 Dec 19;118 Suppl 12B:8-13. doi: 10.1016/j.amjmed.2005.09.008.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lidia Małczak, MSc principal investigator
Poznań University of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the MED and the DASH in people with Metabolic Syndrome and Diet Modification, run by Poznan University of Life Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lidia Małczak, MSc (+48787656850, lidia.malczak@up.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight [kg] (time frame: measurements will be taken after 8 weeks of weight loss diet (before weight loss maintenance period) and after 12, 16, 20, 24, 28, 32 and after 52 week of study.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04136093, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.