Metabolomics Workbench : NIH Data Repository

MB Sample ID: SA330446

Local Sample ID:	DS1-28-41
Subject ID:	SU003159
Subject Type:	Human
Subject Species:	Homo sapiens
Taxonomy ID:	9606
Gender:	Female

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Treatment:

Treatment ID:	TR003168
Treatment Summary:	This study was a clinical trial (NCT02653092) and was approved by the Colorado Multiple Institutional Review Board (COMIRB). All participants provided informed consent. Women aged 18-38 with menstrual cycles 25-35 days in length and no use of reproductive hormones within 3 months of enrollment were eligible for the study. Additional eligibility criteria included: a) no history of chronic disease affecting hormone production, metabolism, or clearance and no use of medications known to interact with reproductive hormones or insulin metabolism; b) normal screening prolactin and TSH; c) normal hemoglobin A1c; d) hemoglobin > 11 g/dl at screening; e) use of reliable non-hormonal contraception throughout the study period. Because the goal was to investigate the effects of a high-fat diet, women with a baseline dietary assessment indicative of >40% calories from fat were excluded, as were women who were unable to comply with the protocol, which involved eating only foods provided by the Colorado Clinical and Translational Sciences Institute’s (CCTSI) Nutrition Services. Because of the restrictions on their ability to consume animal or dairy fats, vegans and lactose intolerant individuals were excluded. Cycle 1 was a baseline cycle; Cycle 2 entailed consumption of the high-fat diet which was continued until frequent blood sampling was completed in the early follicular phase of Cycle 3. Cycle 3 was the immediate post-high-fat-diet cycle and Cycle 4 was a recovery cycle. Participants underwent baseline and end-of-diet assessments of gonadotropin dynamics. A 6-hour frequent blood sampling study was performed to determine endogenous LH and FSH secretion (Time 0-240 minutes) and concluded with a physiologic bolus of 75 ng/kg GnRH to assess pituitary responsiveness (Time 240-360 minutes). Frequent sampling studies for gonadotropin determination were all performed in the early follicular phase of the menstrual cycle (cycle days 2-5). Participants were also seen weekly during the high-fat diet cycle and had a blood draw to assess compliance. High-fat diet protocol. Participants completed a food preference screening survey and a 3-day diet diary, which estimated their daily caloric intake and approximate proportion of daily calories derived from fat. Participants were provided with a customized eucaloric high-fat diet comprised of approximately 48% calories from fat, 33% calories from carbohydrates and 19% calories from protein. Food was portioned into individual meals with snacks and boxed into 3-4 days’ worth at a time. Participants picked up food directly from the Clinical and Translational Research Center; when this was not possible, study staff delivered food to the participant. Urinary ketones were measured at each frequent blood sampling session (Siemens Healthineers, Malvern, PA). During administration of the high-fat diet, blood samples were drawn weekly for metabolomic analysis to determine compliance with the protocol.

Treatment ID:

TR003168

Treatment Summary:

This study was a clinical trial (NCT02653092) and was approved by the Colorado Multiple Institutional Review Board (COMIRB). All participants provided informed consent. Women aged 18-38 with menstrual cycles 25-35 days in length and no use of reproductive hormones within 3 months of enrollment were eligible for the study. Additional eligibility criteria included: a) no history of chronic disease affecting hormone production, metabolism, or clearance and no use of medications known to interact with reproductive hormones or insulin metabolism; b) normal screening prolactin and TSH; c) normal hemoglobin A1c; d) hemoglobin > 11 g/dl at screening; e) use of reliable non-hormonal contraception throughout the study period. Because the goal was to investigate the effects of a high-fat diet, women with a baseline dietary assessment indicative of >40% calories from fat were excluded, as were women who were unable to comply with the protocol, which involved eating only foods provided by the Colorado Clinical and Translational Sciences Institute’s (CCTSI) Nutrition Services. Because of the restrictions on their ability to consume animal or dairy fats, vegans and lactose intolerant individuals were excluded. Cycle 1 was a baseline cycle; Cycle 2 entailed consumption of the high-fat diet which was continued until frequent blood sampling was completed in the early follicular phase of Cycle 3. Cycle 3 was the immediate post-high-fat-diet cycle and Cycle 4 was a recovery cycle. Participants underwent baseline and end-of-diet assessments of gonadotropin dynamics. A 6-hour frequent blood sampling study was performed to determine endogenous LH and FSH secretion (Time 0-240 minutes) and concluded with a physiologic bolus of 75 ng/kg GnRH to assess pituitary responsiveness (Time 240-360 minutes). Frequent sampling studies for gonadotropin determination were all performed in the early follicular phase of the menstrual cycle (cycle days 2-5). Participants were also seen weekly during the high-fat diet cycle and had a blood draw to assess compliance. High-fat diet protocol. Participants completed a food preference screening survey and a 3-day diet diary, which estimated their daily caloric intake and approximate proportion of daily calories derived from fat. Participants were provided with a customized eucaloric high-fat diet comprised of approximately 48% calories from fat, 33% calories from carbohydrates and 19% calories from protein. Food was portioned into individual meals with snacks and boxed into 3-4 days’ worth at a time. Participants picked up food directly from the Clinical and Translational Research Center; when this was not possible, study staff delivered food to the participant. Urinary ketones were measured at each frequent blood sampling session (Siemens Healthineers, Malvern, PA). During administration of the high-fat diet, blood samples were drawn weekly for metabolomic analysis to determine compliance with the protocol.