WELCOME: Diet for the Maintenance of Weight Loss and Metabolic Health in Obese Postmenopausal Women

Sponsor

Poznan University of Life Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04136093

Collaborator

(none)

150

Enrollment

Location

Arms

30.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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).

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Diet Modification Postmenopause	Other: the MED Other: the DASH Other: Control diet	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Basic Science

Official Title:

Defining the Optimal Dietary Strategy for the Maintenance of Weight Loss and mEtaboLiC Outcomes in Centrally Obese postMenopausal womEn (WELCOME Study).

Actual Study Start Date :

Feb 29, 2020

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: 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.
Experimental: 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	Other: 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.
Experimental: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: 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

Other: 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.

Experimental: 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

Other: 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.

Experimental: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

Changes in body weight [kg] [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] [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] [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] [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] [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) [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) [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) [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.

Secondary Outcome Measures

Physical activity level (PAL) [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.]
The assessment of the PAL from 9 to 52 week weight loss maintenance period.
Eating behaviour (by measurement of dietary restraint, disinhibition and hunger) [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.]
The assessment of the eating behaviour from 9 to 52 week weight loss maintenance period.
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 will be done after 12, 16, 20, 24, 28 and 32 week of study.]
The assessment of the adherence from 9 to 32 weeks weight loss maintenance period.
Dietary intake [Each participant"s dietary records will be assessed after 12, 16, 20, 24, 28, and 32 and also after 52 week of study.]
The assessment of the dietary intake from 9 to 52 weeks weight loss maintenance period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 /

or ongoing treatment of previously diagnosed type 2 diabetes.

Exclusion Criteria:

thyroid disease (hypothyroidism, hyperthyroidism, thyroiditis);
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).