Understanding the Paradoxical Rise in Blood Glucose in the Context of a Low-carbohydrate Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Interstitial glucose (continuous glucose monitoring)
研究概览
简要总结
The purpose of this project was to elucidate the phenomenon of elevated blood glucose in the context of dietary carbohydrate restriction. Accordingly, we sought to quantify glucagon, and related hormones, between individuals that are adhering to a low-carbohydrate diet that manifests with normal vs. elevated glucose. Moreover, we sought to test the dynamic effect of macronutrients on these same outcomes. Each participant completed 3 testing periods that included the consumption of a glucose drink, protein drink, or fat (olive oil) drink in a random order and separated by at least 2 days. Each drink was matched for volume and total calories and bloodwork was taken every 30 minutes to assess the outcomes of interest.
详细描述
Using a randomized crossover design with counterbalanced treatment conditions, participants were enrolled in the study for the duration of 4 weeks. Baseline testing took place during the first week and the three intervention conditions took place from weeks 2-4. Participants completed all three intervention arms with a 6- to 10-day washout pe-riod between each intervention session. The order of conditions was randomly deter-mined (randomizer.org) and assigned to participant numbers prior to the start of the study. Participant numbers were given sequentially based on the order in which they signed the consent form and officially enrolled in the study. Before each intervention session, participants were screened for contraindications to ensure continued eligibility. Approval from the university's Institutional Review Board was obtained prior to initiating any aspect of this study.
2.1 Participants
Participants were between 18 and 65 years of age and were weight stable (± 3% body weight) for the past 3 months. Additionally, participants must have been adhering to a low-carbohydrate (50g carbohydrates or less per day) diet at least 2 weeks prior to and during the duration of the one-month study. Requirements for inclusion were vetted through the initial qualification screening and further confirmed at the initial screening appointment. Individuals interested in the study were sent a qualification survey (Qualtrics.com) before enrollment to determine participation eligibility. Potential par-ticipants were excluded if they did not provide written consent for participation or if they met any of the following criteria:
- Diagnosed with chronic disease(s) including cardiac disease, cancer, or liver disease
- Were pregnant or lactating
- Were taking medications including anticoagulants and those that may alter me-tabolism (i.e.- insulin, metformin, and amphetamine-based ADHD medications)
- Had allergies to latex, cow's milk/milk products, olives, chlorhexidine, or dextrose.
- Have had more than 5 X-rays within the past year
2.2 Measurements Blood pressure and heart rate were taken using an automated sphygmomanometer (Omron Inc., Model HEM-907XL) at each visit prior to phlebotomy to ensure safety. If the systolic pressure was less than 100mmHg or if the diastolic pressure was below 60mmHg, phlebotomy was not performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •weight stable (± 3% body weight) for the past 3 months
- •adhering to a low-carbohydrate (50g carbohydrates or less per day) diet at least 2 weeks prior to and during the duration of the one-month study
排除标准
- •unwilling to provide written consent
- •diagnosed with chronic disease(s) including cardiac disease, cancer, or liver disease,
- •pregnant or lactating,
- •taking medications that alter metabolism,
- •allergies to latex, cow's milk/milk products, olives, chlorhexidine, or dextrose,
- •have had more than 5 x-rays in the past year.
结局指标
主要结局
Interstitial glucose (continuous glucose monitoring)
时间窗: 2 hours after consuming the beverage
Interstitial subcutaneous glucose concentrations were measured using the Freestyle Libre 2 continuous glucose monitor (CGM) (Abbott Laboratories).
Plasma Hormone Concentrations
时间窗: At baseline and then at 30, 60, 90, and 120 minutes after consuming the beverage
The Human Metabolic Hormone Magnetic Bead Panel multiplex kit (Sigma-Aldrich, Inc., St. Louis, MO; Catalog # HMHEMAG-34K) was utilized to quantify the plasma concentrations of 13 metabolic hormones including amylin, ghrelin, glucagon, gluca-gon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), inter-leukin 6 (IL-6), insulin, c-peptide, leptin, monocyte chemoattractant protein-1 (MCP-1), pancreatic polypeptide (PP), peptide YY (PYY), and tumor necrosis factor alpha (TNF-α). Venipuncture took place in the human performance laboratory by a trained phlebotomist using standard phlebotomy procedures.
次要结局
- Blood Pressure(Immediately before intervention)
- Weight(Before the start of the intervention (baseline visit).)
- Height(Before the start of the intervention (baseline visit).)
- Body Composition Estimates(Before the start of the intervention (baseline visit).)
- Body Mass Index Computation(Before the start of the intervention (baseline visit).)
研究者
Bruce Bailey
Professor
Brigham Young University