Neoplasms

Skin and Connective Tissue Diseases

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Symptoms and General Pathology

Breast Neoplasms

Weight Loss

Body Weight

Breast Diseases

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Body Weight Changes

All Drugs and Chemicals

Hormones

The diet-induced weight loss group will follow a calorie restricted diet. They are asked to keep their habitual sedentary lifestyle. The aim of this group is to loose 5-6 kg of body weight in 14 weeks time.

Participants in the exercise- plus diet-induced weight loss group are enrolled in an exercise programme. Next to the exercise programme, they will follow a calorie restricted diet.

The aim of this group is to loose 5-6 kg of body weight in 14 weeks time.

The control group is asked to follow a baseline isocaloric diet and to not change their habitual sedentary lifestyle.

Energy restricted diet, according the national guidelines for healthy nutrition, creating a mean energy deficit of 500 kCal/day.

Diet

Exercise programme of 2 hours per week fitness containing endurance and resistance training. And 2 hours of Nordic Walking. Equivalent to an energy expenditure of 350 kCal/day.

Next to the exercise programme participants will follow an energy restricted diet according to the national guidelines of healthy nutrition creating an extra energy deficit of 250 kCal/day.

Mainly exercise induced weight loss

evelyn Monninkhof, PhD

Physical inactivity and overweight are two accepted risk factors for breast cancer. However, because of their correlation it is not clear which is most relevant to risk. The investigators now set out to study whether physical activity in addition to weight loss by diet only, affects sex hormone levels, known to be related to breast cancer risk.

In the SHAPE-2 study 250 healthy overweight/obese and physically inactive women are randomly allocated to a diet-induced weight loss group, a combined exercise- and diet-induced weight loss group or a control group. The aim of the first two intervention groups is to loose 5-6 kg of bodyweight, either by dieting or mainly by increased physical activity. Measurements are performed at baseline and after 21 weeks, the end of the study period.

The aim of this study is to provide insight into the effect of weight loss mainly driven by exercise compared to equivalent weight loss due to nutritional calorie restriction on breast cancer biomarkers.

Postmenopausal women who are sedentary or overweight, have an increased breast cancer risk. It is suggested that these two factors mediate breast cancer risk mainly through sex hormone-related pathways. However, an inactive lifestyle and obesity are highly correlated and it is not clear which is most relevant to risk.

Literature shows that weight loss/ fat loss reduces postmenopausal sex hormone levels, but the question is if there is an additional beneficial effect on hormones of reaching this weight loss by physical activity instead of nutritional interventions.

In this three-armed, two-center intervention study, 250 sedentary postmenopausal women who are aged 50-69 years will first enter a run-in period of 5 weeks. During this period, all participants get a diet, adapted to the guidelines for healthy nutrition, meeting their energy expenditures to maintain stable weight. After this run-in phase they are randomly allocated to a (1) diet induced weight loss group, (2) a combined exercise and diet induced weight loss group or (3) a control group. Participants allocated to the dietgroup will get a calorie restricted diet of -500 kCal/day, they will remain their habitual exercise pattern. Participants in the combined group will follow an exercise programme (combined endurance and strength) of 4 hours of sports per week with an average energy expenditure of 350 kCal/day and a, less strict. And a calorie restricted diet of -250 kCal/day. The aim of both intervention groups is to loose 5-6 kg of body weight during the 14 week intervention period. Participants in the control group are requested to retain the baseline diet and their habitual exercise pattern. Primary study parameters measured at baseline and after 21 weeks are: serum concentrations of endogenous estrogens, endogenous androgens and sex hormone binding globulin. Other study parameters include: body fat distribution, amount of total and abdominal fat, weight, BMI, physical fitness, blood pressure and lifestyle factors.

The aim of this study is to provide insight into the effect of weight loss mainly driven by exercise compared to equivalent weight loss due to nutritional calorie restriction on breast cancer biomarkers. Furthermore, we are specifically interested whether weight loss mainly due to physical exercise induces greater amounts of fat loss (total and abdominal) and subsequently results in more favourable effects on these hormones compared to equivalent diet-induced weight loss.

Analyses of the blood assays and MRI data were masked.

The Effects of Equivalent Weight Loss With or Without Exercise Training on Breast Cancer Risk (SHAPE-2)

The Effects of Equivalent Weight Loss With or Without Exercise Training on Breast Cancer Risk Biomarkers in Postmenopausal Women: the SHAPE-2 Study

Estradiol (total, free), estrone, testosterone, sex hormone binding globulin.

BMI, weight, waist- and hip-circumference, total body fat (DEXA scan), abdominal fat (subcutaneous and visceral, MRI-abdomen) and physical fitness (maximal exercise capacity test by the ramp protocol).

UMC Utrecht

Other Dietary Supplements

Omega 3 Fatty Acid

Low Fat diet

Low Fat high n3 diet

High Fat Diet

Susan K Raatz, PhD, RD

The primary objective of this investigation is to determine whether diets designed to increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment), will favorably affect sex hormone distribution in women in a direction associated with reduced risk of sex hormone-mediated cancer development. Specifically, we hypothesize that an increased concentration of circulating n3 fatty acids will reduce the biochemical markers associated with increased risk for developing certain sex hormone mediated cancers such as breast cancer

The guiding concept of our proposal is that both the total fat and the fatty acid composition of the diet contribute to a milieu associated with the risk for sex-hormone mediated cancers. Specifically, we hypothesize that an increased concentration of circulating n3 fatty acids will reduce the biochemical markers associated with increased risk for developing certain sex hormone mediated cancers such as breast cancer. When compared with the high fat diet, we expect n3 concentrations to increase and sex hormone levels to decrease after both low fat and low fat/n3 rich diets, with the greatest response in the low fat-n3 supplemented group. The aims of this project are: 1) to evaluate the effects of total fat and n3 fatty acid consumption on plasma and urine sex hormone concentrations in postmenopausal women, 2) to evaluate the relationship between plasma concentrations of fatty acids and plasma and urinary sex hormone concentrations, and 3) to evaluate the effects of total fat and n3 fatty acid consumption on the associations between sex hormone concentrations and urinary prostaglandin E2 and thromboxane B2 concentrations.

The primary objective of this investigation is to determine whether diets designed to increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment), will favorably affect sex hormone distribution in women in a direction associated with reduced risk of sex hormone-mediated cancer development. The primary endpoints to be evaluated include plasma and urinary sex hormone concentrations as follows:

Endpoints associates with increased risk factors for breast cancer risk: plasma estradiol (E2), estrone (E1), estrone sulfate (E1 sulfate), testosterone, androstenedione, sex hormone binding globulin (SHBG), dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEAS), Measures of estrogen action: plasma follicle stimulating hormone (FSH), urinary estrogen metabolites.

Measures of systemic arachidonic acid-derived eicosanoids: urinary bicyclo-prostaglandin E2 (PGEa), 2,3-dinor thromboxane B2 (TXB2).

Measures reflecting influence of dietary fat and fatty acid intake: plasma phospholipid, cholesterol ester, triglyceride and free fatty acid composition.

Dietary Fat, Eicosanoids and Breast Cancer Risk

USDA Grand Forks Human Nutrition Research Center

Low Fat Diet

Low Fat, High n3 Diet

Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3

Low Fat, High Fat, Low Fat High Omega 3

Low Fat, Low Fat High Omega 3, High Fat

High Fat, Low Fat, Low Fat High Omega 3

High Fat, Low Fat High Omega 3, Low Fat

Low Fat High Omega 3, High Fat, Low Fat

Low Fat High Omega 3, Low Fat, High Fat

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Susan Raatz, PhD, RD

Plasma Sex Hormone Levels

1st Intervention (8 Weeks)

Washout (8 Weeks)

2nd Intervention (8 Weeks)

3rd Intervention (8 Weeks)

Nutritional and Metabolic Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Overweight

Polycystic Ovary Syndrome

Insulin Resistance

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

Gastrointestinal Agents

Mineral

Insulin

Insulin, Globin Zinc

Magnesium Oxide

Antacids

Anti-Ulcer Agents

Magnesium Supplement

magnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet

Placebo tablets, the same in color, odor and appearance with magnesium tablets, 8 weeks, one tablet every day

This is a double-blind randomized clinical trial which will be started at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size was calculated to be 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic and inflammatory profiles,sex hormone levels will be measured at the beginning and end of the study as well as anthropometric measurements.

Placebo

Ahmad Esmaeilzadeh, Professor

maryam farsinejadmarj, Bachelor

Ahmad Esmaeilzadeh, professor

This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size calculated 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including sex hormone levels, metabolic and inflammatory profiles will be measured at the beginning and end of the study as well as anthropetric measurements.

Effect of Magnesium Supplementation on Polycystic Ovary Syndrome

Effect of Magnesium Supplementation on Metabolic Profile and Sex Hormone Levels in Overweight Women With Polycystic Ovary Syndrome.

Isfahan University of Medical Sciences

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effects of Equivalent Weight Loss With or Without Exercise Training on Breast Cancer Risk (SHAPE-2)	NCT01511276	Breast Cancer R...	Diet Mainly exercise...	50 Years - 69 Years	UMC Utrecht
Dietary Fat, Eicosanoids and Breast Cancer Risk	NCT01824498	Breast Cancer	Low Fat diet Low Fat high n3... High Fat Diet	40 Years - 70 Years	USDA Grand Forks Human Nutrition Research Center
Effect of Magnesium Supplementation on Polycystic Ovary Syndrome	NCT02178150	Polycystic Ovar...	Magnesium Oxide Placebo	20 Years - 45 Years	Isfahan University of Medical Sciences
Effect of Magnesium Supplementation on Polycystic Ovary Syndrome	NCT02178150	Polycystic Ovar...	Magnesium Oxide Placebo	20 Years - 45 Years	Isfahan University of Medical Sciences

Spots Global Cancer Trial Database for sex hormones

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