Interindividual Variability in the Effect of Premeal Almond Supplementation on Glycemic Control - a Double Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
The goal of this study is to learn whether eating a small serving of almonds before meals can improve blood sugar control in adults who have early signs of problems with blood sugar regulation. The main questions it aims to answer are:
- Does eating almonds before a meal reduce the rise in blood sugar after eating?
- Do some people consistently benefit more than others from eating almonds before meals?
详细描述
Large rises in blood sugar after eating are an early warning sign of type 2 diabetes, and simple dietary strategies may help lower this risk. This study aims to understand whether eating a small serving of almonds before meals can help reduce postprandial blood sugar levels in adults who are at increased risk for developing type 2 diabetes. Participants will take part in two phases of the study: one conducted in a research clinic to carefully measure short-term blood sugar responses, and another conducted while participants follow a provided diet at home over a longer period. Sometimes participants will eat almonds before meals, and sometimes they will not. The study hypothesis is that eating almonds before meals will lower blood sugar rises after eating, and that some people will benefit more than others in a consistent way that can be observed both in the clinic and during everyday living.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 25-50 years
- •Females over 40 years must have had a cycle in the last 6 months
- •Body mass index (BMI) at least 18.5 and at most 55.0 kg/m2
- •Impaired blood glucose by at least one of the following criteria:
- •Fasting blood glucose at least 100 mg/dL (5.6 mmol/L) and less than 125 mg/dL (6.9 mmol/L)
- •HbA1c at least 5.7% and less than 6.5%
- •Willing and able to comply with study foods
- •Willing and able to ingest acetaminophen as part of study procedures
- •Able to read, speak, and understand English
排除标准
- •Weight change ≥5% in past 6 months, actively trying to lose weight, or unwilling to remain weight stable throughout the study based on self-report
- •Recent history within past 12 months of medical provider-diagnosed cardiovascular, renal, or liver disease that required treatment
- •Current or past diagnosis of cancer (except skin cancer) in the last 5 years
- •Current or past diagnosis of type 1 or type 2 diabetes
- •Recent history within past 12 months of medical provider-diagnosed gastrointestinal or neurological disorders if not managed/stable for at least 3 months (with or without treatment)
- •Recent history within past 12 months of medical provider-diagnosed psychiatric disorders including eating disorders or severe depression if not managed/stable for at least 3 months (with or without treatment)
- •Food allergies or other reasons preventing consumption of study foods
- •Any glucose-lowering medication except biguanides (e.g., Metformin) if stable for at least 3 months or incretins (i.e., GLP-1RA-based) if stable for at least 3 months
- •Current smoking or vaping or history of smoking or vaping in the past 6 months
- •Binge and/or heavy drinking (i.e., >3 drinks on any given occasion and/or >7 drinks/week)
- •Currently pregnant or planning to become pregnant or breastfeed in the next 3 months by self-report
研究组 & 干预措施
Randomization Sequence 1
One of the randomization sequences. Phase 1: MMTT+, MMTT-, MMTT+, MMTT- | Phase 2: SAD+, SAD-. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition).
干预措施: Premeal almond ingestion (Dietary Supplement)
Randomization Sequence 2
One of the randomization sequences. Phase 1: MMTT-, MMTT+, MMTT-, MMTT+ | Phase 2: SAD+, SAD-. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition).
干预措施: Premeal almond ingestion (Dietary Supplement)
Randomization Sequence 3
One of the randomization sequences. Phase 1: MMTT+, MMTT-, MMTT-, MMTT+ | Phase 2: SAD+, SAD-. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition).
干预措施: Premeal almond ingestion (Dietary Supplement)
Randomization Sequence 4
One of the randomization sequences. Phase 1: MMTT-, MMTT+, MMTT+, MMTT- | Phase 2: SAD+, SAD-. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition).
干预措施: Premeal almond ingestion (Dietary Supplement)
Randomization Sequence 5
One of the randomization sequences. Phase 1: MMTT+, MMTT-, MMTT+, MMTT- | Phase 2: SAD-, SAD+. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition).
干预措施: Premeal almond ingestion (Dietary Supplement)
Randomization Sequence 7
One of the randomization sequences. Phase 1: MMTT+, MMTT-, MMTT-, MMTT+ | Phase 2: SAD-, SAD+. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition).
干预措施: Premeal almond ingestion (Dietary Supplement)
Randomization Sequence 8
One of the randomization sequences. Phase 1: MMTT-, MMTT+, MMTT+, MMTT-, | Phase 2: SAD-, SAD+. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition).
干预措施: Premeal almond ingestion (Dietary Supplement)
Randomization Sequence 6
One of the randomization sequences. Phase 1: MMTT-, MMTT+, MMTT-, MMTT+ | Phase 2: SAD-, SAD+. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition).
干预措施: Premeal almond ingestion (Dietary Supplement)
研究者
Kaja Falkenhain
Postdoctoral Fellow
Pennington Biomedical Research Center