AS272 - WHI nutrition and physical activity assessment study (NPAAS) (Competitive Renewal)
Investigator Names and Contact Information
Ross Prentice
Introduction/Intent
In addition to analysis and reporting activities arising from data collected in the current project period, the major thrust of the RO1 competitive renewal will be the conduct of a controlled feeding study among 150 women in the Seattle components of the WHI OS and DM comparison group. The data generated will be used to develop biomarkers based on blood or urine for various nutrients, and will examine the potential of ActivPALTM monitors for the objective assessment of physical activity. Calibration equations will be obtained by regressing the new biomarkers on corresponding self-report measures and study subject characteristics for use in association studies with cardiovascular disease, cancer and diabetes, among other clinical outcomes, in WHI cohorts. This competitive renewal application to NCI will be submitted in response to PAR-07-259 “Improving Diet and Physical Activity Assessment.”
Specific Aims
Primary Aims:
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To develop nutritional biomarkers through the conduct of a novel controlled feeding study. WHI participants will complete a two-week controlled feeding study. Feeding study diets will be highly individualized and designed to approximate participant usual diets, thus enabling an accurate evaluation of the relationship between intake of specific nutrients or specified quantities of foods and the biomarkers of interest. Biomarkers will be developed by regressing provided nutrient consumption on corresponding blood or urine measures for the nutrient under study as well as other nutrients, and other objectively measured study subject characteristics (e.g., BMI).
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To use the biomarkers developed from the feeding study in Aim 1 to calibrate nutrient consumption and activity-related energy expenditure with application to a wide range of disease association studies in the WHI cohorts (i.e., cancer, cardiovascular disease, diabetes). Calibration equations will be developed by regressing the new biomarkers on corresponding self-report measures and other study subject characteristics for the 450 women who participated in the current phase of NPAAS.
Secondary Aims:
- To quantitatively estimate urine-derived nutritional biomarkers after two weeks on a controlled feeding study diet. The measures will include: nitrogen (protein), fructose, sucrose (sugars), alkylresorcinols (whole grains) and 1- and 3-methylhistidine (meat).
- To quantitatively estimate blood-derived nutritional measures after two weeks on a controlled feeding study diet. The measures will include: carotenoids (fruits and vegetables), α- and γ-tocopherols (fats and oils), phospholipid fatty acids (fats and oils) and folate (fruits and vegetables).
- To objectively measure total energy expenditure (TEE) using a doubly-labeled water protocol.
- To objectively measure physical activity during the same two-week period as the controlled feeding study using an -ActivPAL™ (PAL Technologies, Glasgow, Scotland) worn for 14 days, and resting energy expenditure (REE) from indirect calorimetry. We will compare the properties of [TEE-REE] vs. ActivPAL™ as biomarkers of activity-related energy expenditure (AREE).
- To measure the reliability of nutrient consumption physical activity biomarkers. A subset of 50 women will repeat all study procedures six months after the first application of the protocol.
- To combine the biomarker-calibrated estimates of nutrient consumption and activity-related energy expenditure in this study with that obtained from previous biomarker studies in the WHI in a wide-range of disease association studies in the WHI cohorts.
To meet these aims, 150 women from the WHI Extension Study (Seattle Field Center) will be recruited to participate in a two-week controlled feeding study. All foods and most beverages during the feeding period will be prepared under highly controlled conditions in the Human Nutrition Laboratory at the Fred Hutchinson Cancer Research Center in Seattle. A subset of 50 women will repeat all procedures six months later.
Data Dictionaries and Study Documentation
This section displays all study-related data dictionaries and study-related files. The investigators for this study will upload the datasets, data dictionaries, and other study-related files. Study-related files will be made available to the public one year after the completion of the ancillary study, with the exception of the datasets, which will only be available to those with a Data Distribution Agreement. Those will be available to those with permission to download and will appear as a download link next to the data dictionary
Data Dictionaries
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Study Documents
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| NameNPAAS protocol (050211) 050511 ver.3(NPAAS-FS_AS272).pdf | Description |
Related Papers
Biomarker-based methods and study designs to calibrate dietary intake for assessing diet-disease associations
Background: Dietary biomarkers measured in biospecimens can play an important role in correcting for random and systematic measurement error in self-reported nutrient intake when assessing diet-disease associations. To date, high-quality biomarkers for calibrating self-reported dietary intake have only been developed for a few nutrients. Objectives: To investigate new study designs and regression calibration approaches for calibrating self-reported nutrient intake for use in disease association ...
Keywords: Biomarker; Diet; Feeding Study; Postmenopausal Women
Related Studies: 272
Using controlled feeding study for biomarker development in regression calibration for disease association estimation
Correction for systematic measurement error in self-reported data is an important challenge in association studies of dietary intake and chronic disease risk. The regression calibration method has been used for this purpose when an objectively measured biomarker is available. However, a big limitation of the regression calibration method is that biomarkers have only been developed for a few dietary components. We propose new methods to use controlled feeding studies to develop valid biomarkers f...
Keywords: Measurement Error; Regression Calibration; Feeding Study; Biomarker; Cvd
Using simultaneous regression calibration to study the effect of multiple error-prone exposures on disease risk utilizing biomarkers developed from a controlled feeding study
Systematic measurement error in self-reported data creates important challenges in association studies between dietary intakes and chronic disease risks, especially when multiple dietary components are studied jointly. The joint regression calibration method has been developed for measurement error correction when objectively measured biomarkers are available for all dietary components of interest. Unfortunately, objectively measured biomarkers are only available for very few dietary components,...
Keywords: Measurement Error; Regression Calibration; Feeding Study; Biomarker; Cvd
Regression calibration utilizing biomarkers developed from high-dimensional metabolites
Addressing systematic measurement errors in self-reported data is a critical challenge in association studies of dietary intake and chronic disease risk. The regression calibration method has been utilized for error correction when an objectively measured biomarker is available; however, biomarkers for only a few dietary components have been developed. This paper proposes to use high-dimensional objective measurements to construct biomarkers for many more dietary components and to estimate the d...
Keywords: Measurement Error; Regression Calibration; High-Dimensional Data; Biomarker; Diabetes
Biomarkers for components of dietary protein and carbohydrate with application to chronic disease risk among postmenopausal women
Background: We recently developed protein and carbohydrate intake biomarkers using metabolomics profiles in serum and urine, and used them to correct self-reported dietary data for measurement error. Biomarker-calibrated carbohydrate density was inversely associated with chronic disease risk, whereas protein density associations were mixed. Objectives: To elucidate and extend this earlier work through biomarker development for protein and carbohydrate components, including animal protein and fib...
Keywords: Biomarker; Hazard Ratio Analyses; Measurement Error; Metabolomics; Nutrition; Carbohydrate; Protein
Metabolomics Biomarkers for Fatty Acid Intake and Biomarker-Calibrated Fatty Acid Associations with Chronic Disease Risk in Postmenopausal Women
Background: A substantial observational literature relating specific fatty acid classes to chronic disease risk may be limited by its reliance on self-reported dietary data.
Objectives: We aimed to develop biomarkers for saturated (SFA), monounsaturated (MUFA), and polyunsaturated (PUFA) fatty acid densities, and to study their associations with cardiovascular disease (CVD), cancer, and type 2 diabetes (T2D) in Women's Health Initiative (WHI) cohorts.
Methods: Biomarker equations were based prim...
Keywords: Biomarker; Cancer; Cardiovascular Disease; Diabetes; Healthy Eating Pattern; Metabolomics
Biomarker-calibrated red and combined red and processed meat intakes with chronic disease risk in a cohort of postmenopausal women
Background: The associations of red and processed meat with chronic disease risk remains unsettled, in part because of measurement error in self-reported diet. Objectives: To develop metabolomics-based biomarkers for red and processed meat, and to associate biomarker-calibrated meat intake with chronic disease risk among postmenopausal women. Design: Women's Health Initiative (WHI) cohorts were utilized. Participants were postmenopausal women aged 50-79 y when enrolled at 40 US clinical centers ...
Keywords: Biomarker; Calibration; Cancer; Cardiovascular Disease; Diabetes; Feeding Study; Metabolomics; Processed Meat; Red Meat
Related Studies: 272
Four-day food record macronutrient intake, with and without biomarker calibration, and chronic disease risk in postmenopausal women
We recently presented associations of biomarker-calibrated protein, protein density, carbohydrate, and carbohydrate density with the incidence of cardiovascular diseases, cancers, and diabetes in Women's Health Initiative cohorts (1993 to present, at 40 US clinical centers) of postmenopausal women. The biomarkers relied on serum and urine metabolomics profiles, and biomarker-calibration used regression of biomarkers on food frequency questionnaires. Here corresponding calibration equations are d...
Keywords: Biomarker; Odds Ratio; Measurement Error; Metabolomics; Nutrition
Related Studies: 272
Metabolomics-Based Biomarker for Dietary Fat and Associations with Chronic Disease Risk in Postmenopausal Women
Background: The Women's Health Initiative (WHI) randomized, controlled Dietary Modification (DM) trial of a low-fat dietary pattern suggested intervention benefits related to breast cancer, coronary heart disease (CHD), and diabetes. Here we use WHI observational data for the further insight into the chronic disease implications of adopting this type of low-fat dietary pattern.
Objectives: We aim to use our earlier work on metabolomics-based biomarkers of carbohydrate and protein to develop a fa...
Keywords: Biomarker; Cancer; Cardiovascular Disease; Diabetes; Dietary Fat; Metabolomics; Regression Calibration
Use of a urinary sugars biomarker to assess measurement error in self-reported sugars intake in the Nutrition and Physical Activity Assessment Study (NPAAS)
Measurement error in self-reported sugars intake may be obscuring the association between sugars and cancer risk in nutritional epidemiologic studies.We used 24-hour urinary sucrose and fructose as a predictive biomarker for total sugars, to assess measurement error in self-reported sugars intake. The Nutrition and Physical Activity Assessment Study (NPAAS) is a biomarker study within the Women's Health Initiative (WHI) Observational Study that includes 450 postmenopausal women ages 60 to 91 yea...
Keywords: Dietary Biomarkers; Urinary Sugars; Total Sugars; Diet; Npaas; Measurement Error
Pooled results from 5 validation studies of dietary self-report instruments using recovery biomarkers for energy and protein intake
We pooled data from 5 large validation studies of dietary self-report instruments that used recovery biomarkers as references to clarify the measurement properties of food frequency questionnaires (FFQs) and 24-hour recalls. The studies were conducted in widely differing US adult populations from 1999 to 2009. We report on total energy, protein, and protein density intakes. Results were similar across sexes, but there was heterogeneity across studies. Using a FFQ, the average correlation coeffic...
Keywords: 24-Hour Recall; Attenuation Factors; Calibration Equations; Dietary Measurement Error; Food Frequency Questionnaire; Under-Reporting
Associations of biomarker-calibrated sodium and potassium intake and cardiovascular disease risk among postmenopausal women
Studies of sodium and potassium intake and cardiovascular disease incidence often rely on self-reported dietary data. Here self-reported intakes from postmenopausal women at 40 participating U.S. clinical centers are calibrated using 24-hour urinary excretion measures in Women's Health Initiative cohorts, with follow-up over 1993-2010. Hypertension incidence related positively to (calibrated) sodium intake and to the ratio of sodium-to-potassium. The sodium-to-potassium ratio was associated with...
Keywords: Bias (Epidemiology); Cardiovascular Disease; Energy Consumption; Hazard Ratio; Measurement Error; Odds Ratio; Potassium; Regression Calibration; Sodium
Dietary biomarker evaluation in a controlled feeding study in women from the Women's Health Initiative cohort
BACKGROUND: Controlled human feeding studies are necessary for robust nutritional biomarker development and validation. Previous feeding studies have typically evaluated single nutrients and tested relatively few diets. OBJECTIVES: The objectives were 1) to simultaneously associate dietary intake with a range of potential nutritional biomarkers in postmenopausal women by using a controlled feeding study whereby each participant was provided a diet similar to her usual diet and 2) to evaluate ser...
Keywords: Carotenoids; Doubly Labeled Water; Energy; Fatty Acids; Folate; Human Feeding Study; Nutrition Assessment; Protein; Tocopherols; Vitamin B-12
Measuring diet by metabolomics: a 14-d controlled feeding study of weighed food intake
Background: Metabolomics has the potential to enhance dietary assessment by revealing objective measures of many aspects of human food intake. Although metabolomics studies indicate that hundreds of metabolites are associated with dietary intake, correlations have been modest (e.g., r < 0.50), and few have been evaluated in controlled feeding studies. Objectives: The aim of this study was to evaluate associations between metabolites and weighed food and beverage intake in a controlled feeding st...
Keywords: Serum; Urine; Metabolite; Metabolomics; Diet; Nutrition; Weighed Food; Biomarker
Novel application of nutritional biomarkers from a controlled feeding study and observational study toward dietary pattern characterization in postmenopausal women
Dietary guidance emphasizes healthy dietary patterns, but supporting evidence comes from measurement-error prone self-reported diet. We explored whether nutritional biomarkers from the Women's Health Initiative Nutrition and Physical Activity Assessment Study Feeding Study (n=153; 2010-2014) and the WHI-NPAAS Observational Study (NPAAS-OS; n=450; 2006-2009) could identify biomarker signatures of dietary patterns for development of corresponding regression calibration equations to help mitigate m...
Keywords: Biomarkers; Dietary Assessment; Healthy Eating Index; Measurement Error; Dietary Patterns
Biomarker-assessed total energy intake and its association with all-cause mortality in postmenopausal women
Background: The association of total energy intake (EI) with all-cause mortality is uncertain, as are the dependencies of this association on age and weight change history. Objectives: To identify an EI biomarker suitable for use in epidemiologic association studies, and to study EI associations with total mortality in a Women's Health Initiative (WHI) cohort of postmenopausal U.S. females (1993-present). Design: EI biomarkers were developed based on doubly-labeled water (DLW) total energy expen...
Keywords: Body Weight; Cancer; Diabetes; Doubly-Labeled Water; Energy Intake
Total energy expenditure as assessed by doubly labeled water and all-cause mortality in a cohort of postmenopausal women
Background: The association of TEE with all-cause mortality is uncertain, as is the dependence of this association on age. Objectives: To examine the association between TEE and all-cause mortality, and its age interaction, in a Women's Health Initiative (WHI) cohort of postmenopausal United States women (1992-present). Methods: A cohort of 1131 WHI participants having DLW TEE assessment of ∼10.0 y (median) following WHI enrollment with ∼13.7 y (median) of subsequent follow-up, was used to study...
Keywords: Body Mass Index; Cancer; Cardiovascular Disease; Diabetes; Doubly-Labeled Water; Energy Consumption
Association of biomarker-calibrated animal protein intake with cardiovascular disease risk and mortality in postmenopausal women
Keywords: Animal Protein Intake; Protein Intake Pattern; Carbon Isotope Ratio; Biomarker-Calibrated Dietary Intake Estimates; Cardiovascular Disease
Biomarker-calibrated estimates of added sugar intake and associations with chronic disease outcomes in postmenopausal women
Keywords: Added Sugar; Amino Acid Carbon Isotope Ratio; Metabolomics; Biomarker-Calibrated Dietary Intake Estimates; Type 2 Diabetes; Cardiovascular Disease; Cancer
