Impact of a strong fiber, low-fat diet intervention... Part #2

Impact of a strong fiber, low-fat diet intervention... Part #2

PARTICIPANTS AND METHODS

The participants

The data were from a subgroup of 400 women, the Women's Healthy Eating and Living (WHELAN) behind them, the study of the assessment of food and blood, a collection of reference and 12 months. WHELAN, the minutes of the study, including selection criteria, data collection, methodology and the intervention is offered elsewhere. Consideration of the application, the information on the history of medicine and the application of drugs were. The participants for this section were the first systematic sample of 400 women in the study WHELAN. Within each group (and the comparison), we have the first 100 participants in the electricity supply and the data that are less than 50 years in the amount of tuition fees and 100 women over 50 years. On average, the women 2 years after diagnosis of cancer at the time of recording. Each participant in the a-, or tamoxifen daily during the study does not consider the tamoxifen or during the study with tamoxifen does not change over time in an individual before. This medicine may be the circulating concentrations of reproductive steroid hormones, and it may therefore interfere with the analysis. Six women were as a result of this analysis because of insufficient data.

Collections of blood in the study did not WHELAN phase of the menstrual cycle and the interpretation of the relationships between the data of the hormone balance and nutrition of women in the fluctuations of the economy, the subject of an error. In particular, most participants in the study, which préménopause WHELAN his diagnosis of breast cancer has the ovulatory failure in combination with the initial treatment. Therefore, we have two criteria for the participants in the serum concentrations of estrogen can be examined in order to change over time in response to changes in diet, which in this analysis: Each participant has the message no menses in the 12 months before or after the date of registration and the serum follicle stimulating hormone (FSH)> 10 mIU / ml to 12 months and the clinic (n = 291). The aim of this FSH fraction "is for women after menopause, which is clearly a verdict of FSH> 30 to 35 mU / ml The participants of this subsidiary was managed by women, it is unlikely that the cycle of secretion of estrogen and exhibition are therefore primarily killed or mail.

Procedure

The participants were given at random to one of the two studies were laminated according to the stage of the disease, age and location of the clinic. The group of comparison is recommended to consume a food, with the general dietary recommendations for cancer prevention (five servings of fruit and vegetables per day, 20 g / day of dietary fiber, and ≤ 30% of energy from fats). The intervention group were, therefore, should be five servings of vegetables per day, three servings of fruit per day, 16 fluid ounces vegetable juice per day, 30 g / day of dietary fiber, and 15% to 20% of energy from fat. Intensive telephone-based nutrition counseling program, a group of twelve cookery courses and printed materials were used for the modification of diet in the intervention. The participants in the comparison group were invited to four cooking lessons with the intervention were the goals and the supply of material for the orientation state agency.

Relevant in this submenu, the clinical visits during the registration and 1 year in which a blood sample taken on an empty stomach was the size and weight have been developed using the standard, and the Body Mass Index (BMI, weight [kg] / size [m2]) was calculated. The institutional system for the review of all procedures used by the participating institutions for this study and written consent was signed by all the participants in the study prior to the start.

Nutrition and physical data

The most important method for the assessment of nutrition in this study consisted of 24-hour recalls are repeated. Details on the methodology of the diet is, incidentally. In short, each participant has four study the 24-hour recalls, including 2 days and 2 days weekend in a period of 3 weeks. Food assessors trained, blind, or the intervention group compared with distribution of participants in the course of telephone conversations. Calculations of nutrients were compared with data from the system of nutrition for the software database of food and nutrients 31, Version 4 / 03, published in November 2000 (Coordination Center for Nutrition, University of Minnesota, Minneapolis, MN).

Start and 12 months, the frequency, duration and intensity of physical activity was by questionnaire and converted metabolic equivalents (METS). Total expenditure on energy is determined by weighting the time per week per METS light physical activity was weighted 3 Mets, moderate activity was weighted 5 Food and strong activity was weighted 8 Mets. METS were walking by the slow speed. Unknown or 2 mph travel speed was weighted Mets 2, 3 mph was the weighted METS 3, 4 mph walking was weighted 4 Mets and ≥ 5 mph walking was weighted 6 Mets. METS are not in the hour of the meeting or to sleep.

The biochemical

Blood samples were immediately put on ice and in darkness, and separated by 1 hour after the collection, using centrifugation 2300 xg at 4 ° C for 10 minutes. Serum aliquots were preserved at -80 ° C in cryogenic tubes until analysis. Serum concentrations of these hormones were in the samples, during the registration and 1 year: estradiol, bioavailable estradiol, estrone, estrone sulfate, Androstendion, testosterone and dehydroepiandrosterone (DHEA)-sulfate. Bioavailable estradiol is globulin between the sex hormones (SHBG), estradiol (free estradiol specific albumin).

The method for measurement of estradiol to estrone and testosterone Androstendion which is a modification of the method of Anderson et al, using radioimmunoassay (RIA) for quantification. Measuring the bioavailability of estradiol based on the method of Tremblay and Dubé. The results of the commercially available kits (Diagnostic Systems Laboratories, Webster, TX) were used to estrone sulfate and DHEA sulfate. The laboratory inter-assay coefficient of variation (CV) was 9.9% estradiol, 5.12% of the bioavailability of estradiol, estrone on the 11.8%, 3.88% estrone sulfate, 7.92% of Androstendion of 9.2% for testosterone and DHEA sulfate 5.07%. The concentrations of steroids were found in comparison to a standard, commercially available (ICN Pharmaceuticals, Costa Mesa, CA). Cross-reactivity of antibodies in the ARI was by comparison to all the substances that are very close, and cross-reacting substances in the chromatographic column by step in front of the entrance there.

Commercially available kits were used for the quantification of FSH and SHBG. SHBG is helpful in the interpretation of serum concentrations of FSH and estrogen on the screen of the topics for inclusion in this section. The method of SHBG is determined in fluoroimmunoassay (Delphia SHBG, EG & G, Diagnostic Systems Laboratories) and the inter-laboratory assay CV is 5.94%. The method is an RIA FSH (FSH immunoradiometric dosage, Diagnostic Products Corp., Los Angeles, CA) and the inter-laboratory assay CV is 3.59%.

Statistical analysis

Descriptive analysis and a summary of statistical data to describe the sample of investigation, and () 2 Chi or independent t-tests were used to display the properties of the two groups of the study to register. Independent T tests were used to the consumption of the two groups in the study and 1-year follow-up. Serum hormone concentrations of distributions that are very different, so that these values were log to the standard prior to analysis. Basic and 1 year and the serum concentrations of the hormone to the differences of 1 year were the changes in the intervention group compared with independent t tests Independent T tests were used for the serum levels of estradiol and bioavailable estradiol and different concentrations of 1 year on changes in the use of tamoxifen in the study groups. Paired t-tests were used to the changes in the database of 1 year in serum concentrations of the hormone in the intervention and comparison. Using the linear regression analysis, the changes in the bioavailability of estradiol and the sum of the concentrations of estradiol were modeled as a change in the fiber and energy percent fat, the serum concentration of hormones to control the use of tamoxifen and change in BMI. All analyzes were carried out with the Statistical Analysis System (SAS) Version 8 / 01 and SAS STAT User's Guide, Version 6 (SAS Institute Inc., Cary, NC).

Table 1 shows the demographic characteristics and the other participants of the study. There were no significant differences in age, and BMI, physical activity and the use of tamoxifen between the two groups in the study are presented in this analysis. Although racial and ethnic distribution was in both groups of study in the clinical trial population of this sample of women after menopause have a greater number of minorities in the intervention compared with the comparison group (16% versus 8% at P < .05). Nonmenstruating This sub-sample of 291 women with FSH> 10 mU / ml for registration and 1 years, 110 had an FSH concentration of> 10 and less than 30 mU / ml

Table 1. Participant Demographic and Clinical Characteristics at Enrollment, by Study Group Assignment

	Comparison Group (n = 138)		Intervention Group (n = 153)
	No. of Participants %		No. of Participants %
Age, years
Mean	56		54
SD	8		8
Body mass index, kg/m2
Mean	27.5		27.7
SD	6.0		6.6
Exercise METs/week
Mean	878		935
SD	864		879
Cancer stage
I	56	41	49	32
II	75	54	101	66
IIIA	7	5	3	2
Tamoxifen use
No	60	43	59	39
Yes	78	57	94	61
Ethnicity
Non-Hispanic white	127	92	129	84
Minority	11	8	24	16*