Eating Almonds Before a Meal to Control Blood Sugar (NUTS)
15 июля 2026 г. обновлено: Kaja Falkenhain, Pennington Biomedical Research Center
Interindividual Variability in the Effect of Premeal Almond Supplementation on Glycemic Control - a Double Crossover Study
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?
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
25
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Kaja Falkenhain, PhD
- Номер телефона: 225-763-2558
- Электронная почта: kaja.falkenhain@pbrc.edu
Места учебы
-
-
Louisiana
-
Baton Rouge, Louisiana, Соединенные Штаты, 70808
- Рекрутинг
- Pennington Biomedical Research Center
-
Контакт:
- Kaja Falkenhain, PhD
- Номер телефона: 225-763-2558
- Электронная почта: kaja.falkenhain@pbrc.edu
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Да
Описание
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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).
|
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
|
|
Экспериментальный: 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).
|
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
|
|
Экспериментальный: 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).
|
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
|
|
Экспериментальный: 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).
|
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
|
|
Экспериментальный: 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).
|
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
|
|
Экспериментальный: 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).
|
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
|
|
Экспериментальный: 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).
|
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
|
|
Экспериментальный: 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).
|
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Postprandial glucose assessed during acute meal test
Временное ограничение: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
|
The primary endpoint will be the difference in plasma glucose incremental area under the curve (iAUC) assessed via intravenous blood sampling over three hours following a standardized mixed meal tolerance test (MMTT) with premeal ingestion of 18 g of almonds 30 minutes prior (MMTT+) compared to without (MMTT-).
This effect will be averaged across the replicated acute challenge visits in the repeated crossover design.
|
Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Interindividual variability in the postprandial glucose assessed during acute meal test
Временное ограничение: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
|
Variability in response to the single-dose, acute premeal almond supplementation prior to the MMTT will be characterized according to previously established procedures using Pearson's correlation between the first and second replicate of the control-adjusted treatment effect (i.e., MMTT+ vs MMTT-).
That is, the correlation between the difference in iAUC during the first crossover trial (i.e., iAUC during MMTT+ minus iAUC during MMTT-) and the difference in iAUC during the second crossover trial (i.e., iAUC during MMTT+ minus iAUC during MMTT-).
|
Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
|
|
Consistency between acute glycemic response and longer-term glycemic control
Временное ограничение: Days 1-4: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes. Days 5-25
|
Whether the individual glucose-lowering effect of the almond preload observed during the acute, repeated crossover, controlled in-laboratory MMTT predicts an individual's glycemic control during the 10-day, free-living, controlled-feeding phase in which almonds will be consumed thrice daily prior to each main meal on the background of a Standard American diet.
We will evaluate this via the regression coefficient derived from a linear regression with the magnitude of the acute treatment effect in Days 1-4 (i.e., the difference in iAUC between MMTT+ and MMTT- averaged between both crossover trials) as the predictor and the magnitude of the treatment effect in Days 5-25 (i.e., the difference in average iAUC across the 10-day controlled feeding diet periods between MMTT+ and MMTT-) as the outcome.
|
Days 1-4: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes. Days 5-25
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Acute postprandial glucose
Временное ограничение: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
|
The difference in plasma glucose assessed via intravenous blood sampling over three hours following a standardized mixed meal tolerance test (MMTT) with premeal ingestion of 18 g of almonds 30 minutes prior (MMTT+) compared to without (MMTT-).
This effect will be averaged across the replicated acute challenge visits in the repeated crossover design.
|
Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
|
|
Acute postprandial gastric emptying
Временное ограничение: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
|
The difference in acetaminophen appearance (gastric emptying) assessed via intravenous blood sampling over three hours following a standardized mixed meal tolerance test (MMTT) with premeal ingestion of 18 g of almonds 30 minutes prior (MMTT+) compared to without (MMTT-).
This effect will be averaged across the replicated acute challenge visits in the repeated crossover design.
|
Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
|
|
Acute postprandial insulin
Временное ограничение: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
|
The difference in plasma insulin assessed via intravenous blood sampling over three hours following a standardized mixed meal tolerance test (MMTT) with premeal ingestion of 18 g of almonds 30 minutes prior (MMTT+) compared to without (MMTT-).
This effect will be averaged across the replicated acute challenge visits in the repeated crossover design.
|
Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
|
|
Acute postprandial glucagon-like peptide 1
Временное ограничение: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
|
The difference in plasma glucagon-like peptide 1 assessed via intravenous blood sampling over three hours following a standardized mixed meal tolerance test (MMTT) with premeal ingestion of 18 g of almonds 30 minutes prior (MMTT+) compared to without (MMTT-).
This effect will be averaged across the replicated acute challenge visits in the repeated crossover design.
|
Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
|
|
Cardiometabolic health - fasting glucose
Временное ограничение: Days 5-25
|
The difference in the change of fasting plasma blood glucose from before to after a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
|
Cardiometabolic health - fasting high-density lipoprotein cholesterol
Временное ограничение: Days 5-25
|
The difference in the change of fasting high-density lipoprotein cholesterol from before to after a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
|
Cardiometabolic health - fasting low-density lipoprotein cholesterol
Временное ограничение: Days 5-25
|
The difference in the change of fasting low-density lipoprotein cholesterol from before to after a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
|
Cardiometabolic health - fasting total cholesterol
Временное ограничение: Days 5-25
|
The difference in the change of fasting total cholesterol from before to after a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
|
Cardiometabolic health - fasting insulin
Временное ограничение: Days 5-25
|
The difference in the change of fasting plasma insulin from before to after a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
|
Cardiometabolic health - fasting glucagon-like peptide 1
Временное ограничение: Days 5-25
|
The difference in the change of fasting glucagon-like peptide 1 from before to after a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
|
Cardiometabolic health - fasting C-reactive protein
Временное ограничение: Days 5-25
|
The difference in the change of fasting C-reactive protein from before to after a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
|
Cardiometabolic health - 24-hour glucose
Временное ограничение: Days 5-25
|
The difference in average 24-hour glucose assessed via CGM during a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
|
Cardiometabolic health - glucose incremental area under the curve
Временное ограничение: Days 5-25
|
The difference in average meal blood glucose incremental area under the curve (iAUC) assessed via CGM during a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
|
Cardiometabolic health - glucose area under the curve
Временное ограничение: Days 5-25
|
The difference in average meal blood glucose area under the curve (AUC) assessed via CGM during a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
|
Cardiometabolic health - glucose standard deviation
Временное ограничение: Days 5-25
|
The difference in average blood glucose standard deviation (SD) assessed via CGM during a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
|
Cardiometabolic health - glucose coefficient of variation
Временное ограничение: Days 5-25
|
The difference in average blood glucose coefficient of variation (CV) assessed via CGM during a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
|
Cardiometabolic health - glucose time in range
Временное ограничение: Days 5-25
|
The difference in average glucose time in range assessed via CGM during a 10-day controlled feeding diet period with thrice daily premeal ingestion of 18 g of almonds 30 minutes to each meal (MMTT+) compared to without (MMTT-).
|
Days 5-25
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
23 июня 2026 г.
Первичное завершение (Оцененный)
1 марта 2028 г.
Завершение исследования (Оцененный)
1 июля 2028 г.
Даты регистрации исследования
Первый отправленный
8 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
16 мая 2026 г.
Первый опубликованный (Действительный)
22 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
17 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
15 июля 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- PBRC 2026-009
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
Data will be shared upon reasonable request to the study investigator and upon successful execution of a data transfer/sharing agreement.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .