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Effects of a low-fat dietary intervention on glucose, insulin, and insulin resistance in the Women's Health Initiative (WHI) Dietary Modification trial.

ABSTRACT: BACKGROUND:Glycemic effects of the Women's Health Initiative (WHI) low-fat dietary intervention are unknown. OBJECTIVE:Our objective was to analyze the effects of the WHI low-fat dietary intervention on serum glucose and insulin and insulin resistance up to 6 y after random assignment. DESIGN:Postmenopausal WHI Dietary Modification trial intervention (DM-I) and comparison (DM-C) participants with blood measures at least at baseline and year 1 (n = 2263) were included. Anthropometric measures, dietary assessments, serum glucose and insulin concentrations, homeostasis model assessment of insulin resistance (HOMA-IR) measures, and quantitative insulin sensitivity check index (QUICKI) values were obtained at baseline, year 1, year 3, and year 6. Changes in measures were compared between groups at years 1, 3, and 6 overall and within stratified analyses. RESULTS:Mean (±SD) differences in changes at year 1 between the DM-I and DM-C groups were as follows: glucose, -1.7 ± 17.9 mg/dL; insulin, -0.7 ± 5.1 ?IU/mL; HOMA-IR, -0.2 ± 1.9; and QUICKI, 0.004 ± 0.019 (all P < 0.05). Similar findings resulted from repeated-measures analyses comparing the intervention and comparison groups over the 6 y. Whereas normoglycemic women at baseline had a decrease in glucose at year 1 that was 1.9 ± 17.2 mg/dL greater in the DM-I than in the DM-C group, diabetic women had an increase in glucose that was 7.9 ± 20.3 mg/dL greater in the DM-I than in the DM-C group (P for interaction <0.001). CONCLUSIONS:A low-fat diet was not significantly associated with adverse glycemic effects up to 6 y after random assignment in postmenopausal women. However, diabetic women experienced adverse glycemic effects of the low-fat diet. This trial is registered at clinicaltrials.gov as NCT00000611.

SUBMITTER: Shikany JM

PROVIDER: S-EPMC3127523 | biostudies-literature | 2011 Jul

REPOSITORIES: biostudies-literature

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Effects of a low-fat dietary intervention on glucose, insulin, and insulin resistance in the Women's Health Initiative (WHI) Dietary Modification trial.

Shikany James M JM Margolis Karen L KL Pettinger Mary M Jackson Rebecca D RD Limacher Marian C MC Liu Simin S Phillips Lawrence S LS Tinker Lesley F LF

The American journal of clinical nutrition 20110511 1

<h4>Background</h4>Glycemic effects of the Women's Health Initiative (WHI) low-fat dietary intervention are unknown.<h4>Objective</h4>Our objective was to analyze the effects of the WHI low-fat dietary intervention on serum glucose and insulin and insulin resistance up to 6 y after random assignment.<h4>Design</h4>Postmenopausal WHI Dietary Modification trial intervention (DM-I) and comparison (DM-C) participants with blood measures at least at baseline and year 1 (n = 2263) were included. Anthr ...[more]

PMID: 21562091

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Project description:BackgroundMeta-analyses of observational studies associate adherence to several dietary patterns with cognitive health. However, limited evidence from full scale, randomized controlled trials precludes causal inference regarding dietary effects on cognitive function.MethodsThe Women's Health Initiative (WHI) Dietary Modification (DM) randomized trial, in 48,835 postmenopausal women, included a subset of 1,606 WHI Memory Study (WHIMS) participants >= 65 years old, to assess low-fat dietary pattern influence on global cognitive function, evaluated with annual screening (Modified Mini-Mental State Examinations [3MSE]). Participants were randomized by a computerized, permuted block algorithm, stratified by age group and center, to a dietary intervention (40%) to reduce fat intake to 20% of energy and increase fruit, vegetable and grain intake or usual diet comparison groups (60%). The study outcome was possible cognition impairment (failed cognitive function screening) through the 8.5 year (median) dietary intervention. Those failing screening received a comprehensive, multi-phase cognitive function assessment to classify as: no cognitive impairment, mild cognitive impairment, or probable dementia. Exploratory analyses examined the composite endpoint of death after possible cognitive impairment through 18.7 years (median) follow-up. The WHI trials are registered at ClinicalTrials.gov:NCT00000611.FindingsAmong the 1,606 WHIMS participants, the dietary intervention statistically significantly reduced the incidence of possible cognitive impairment (n = 126; hazard ratio [HR] 0.59 95% confidence interval [CI] 0.38-0. 91, P = 0.01) with HR for dietary influence on subsequent mild cognitive impairment of 0.65 (95% CI 0.35-1.19) and HR of 0.63 (95% CI 0.19-2.10) for probable dementia (PD). Through 18.7 years, deaths from all-causes after possible cognitive impairment were non-significantly lower in the dietary intervention group (0.56% vs 0.77%, HR 0.83 95% CI 0.35 to 2.00, P = 0.16).InterpretationAdoption of a low-fat eating pattern, representing dietary moderation, significantly reduced risk of possible cognitive impairment in postmenopausal women.FundingSeveral Institutes of the US National Institutes of Health.

Project description:BACKGROUND:Intensive dietary intervention programs may lead to benefits in vitality and other components of health quality. The Women's Health Initiative Dietary Modification (DM) intervention includes a large randomized controlled trial of an intensive intervention. OBJECTIVE:To evaluate whether the intervention is associated with improved health-related quality of life (HRQoL) subscales, overall self-reported health, depression symptoms, cognitive functioning, and sleep quality. DESIGN:This randomized controlled trial was analyzed as intent to treat. PARTICIPANTS:Between 1993 and 1998, 48,835 women aged 50 to 79 years were recruited by 40 clinical centers across the United States. Eligibility included having fat intake at baseline ?32% of total calories, and excluded women with any prior colorectal or breast cancer, recent other cancers, type 1 diabetes, or medical conditions with predicted survival <3 years. INTERVENTION:Goals were to reduce calories from fat to 20%, increase vegetables and fruit to 5+ servings, and increase grain servings to 6+ servings a day. During the first year, 18 group sessions were held, with quarterly sessions thereafter. MAIN OUTCOME MEASURES:The RAND 36-Item Health Survey was used to assess HRQoL at baseline, Year 1, and close-out (about 8 years postrandomization), and estimate differential HRQoL subscale change scores. STATISTICAL ANALYSES PERFORMED:Mean change in HRQoL scores (Year 1 minus baseline) were compared by randomization group using linear models. RESULTS:At 1 year, there was a differential change between intervention and comparison group of 1.7 units (95% CI 1.5, 2.0) in general health associated with the intervention. DM intervention improved physical functioning by 2.0 units (95% CI 1.7, 2.3), vitality by 1.9 units (95% CI 1.6, 2.2), and global quality of life by 0.09 units (95% CI 0.07, 0.12). With the exception of global quality of life, these effects were significantly modified by body mass index at baseline. CONCLUSIONS:DM intervention was associated with small, but significant improvements in three HRQoL subscales: general health, physical functioning, and vitality at 1 year follow-up, with the largest improvements seen in the women with the greatest baseline body mass index.

Project description:BackgroundThe Women's Health Initiative Dietary Modification (DM) Randomized Controlled Trial evaluated the effects of a low-fat dietary pattern on chronic disease incidence, with breast cancer and colorectal cancer as primary outcomes. The trial protocol also listed ovarian cancer and endometrial cancer as outcomes that may be favorably affected by the intervention.MethodsA total of 48,835 postmenopausal women were randomly assigned during 1993-1998 to a DM intervention (n = 19,541) or comparison (usual diet; n = 29,294) group and followed up for an average of 8.1 years. The intervention goal was to reduce total fat intake to 20% of energy and to increase consumption of vegetables, fruits, and grains. Cancer outcomes were verified by pathology report review. We used weighted log-rank tests to compare incidence of invasive cancers of the ovary and endometrium, total invasive cancer, and invasive cancers at other sites between the groups. All statistical tests were two-sided.ResultsOvarian cancer risk was lower in the intervention than in the comparison group (P = .03). Although the overall ovarian cancer hazard ratio (HR) was not statistically significantly less than 1.0, the hazard ratio decreased with increasing intervention duration (P(trend) = .01). For the first 4 years, the risk for ovarian cancer was similar in the intervention and control groups (0.52 cases per 1000 person-years in the intervention group versus 0.45 per 1000 person-years in the comparison group; HR = 1.16, 95% confidence interval [CI] = 0.73 to 1.84); over the next 4.1 years, the risk was lower in the intervention group (0.38 cases per 1000 person-years in the intervention group versus 0.64 per 1000 person-years in the comparison group; HR = 0.60, 95% CI = 0.38 to 0.96). Risk of cancer of the endometrium did not differ between the groups (P = .18). The estimated risk of total invasive cancer was slightly lower in the intervention group than in the control group (HR = 0.95, 95% CI = 0.89 to 1.01; P = .10).ConclusionsA low-fat dietary pattern may reduce the incidence of ovarian cancer among postmenopausal women.

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Effects of a low-fat dietary intervention on glucose, insulin, and insulin resistance in the Women's Health Initiative (WHI) Dietary Modification trial.

Publications

Effects of a low-fat dietary intervention on glucose, insulin, and insulin resistance in the Women's Health Initiative (WHI) Dietary Modification trial.

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