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NCT Number: NCT07603739

Eating Almonds Before a Meal to Control Blood Sugar

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:

1. Does eating almonds before a meal reduce the rise in blood sugar after eating? 2. Do some people consistently benefit more than others from eating almonds before meals?

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Key information

Conditions

Glucose Control Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Nutritional and Metabolic Diseases Precision Medicine Prediabetes (Insulin Resistance, Impaired Glucose Tolerance) Prediabetic State

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location status: Recruiting

Location contact

Kaja Falkenhain, PhD

CONTACT

[email protected]

225-763-2558

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Premeal almond ingestion

Dietary Supplement

Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal

Primary outcomes

  1. Postprandial glucose assessed during acute meal test

    Time frame: 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.

Secondary outcomes

  1. Interindividual variability in the postprandial glucose assessed during acute meal test

    Time frame: 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-).

  2. Consistency between acute glycemic response and longer-term glycemic control

    Time frame: 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.

Other outcomes

  1. Acute postprandial glucose

    Time frame: 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.

  2. Acute postprandial gastric emptying

    Time frame: 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.

  3. Acute postprandial insulin

    Time frame: 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.

  4. Acute postprandial glucagon-like peptide 1

    Time frame: 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.

  5. Cardiometabolic health - fasting glucose

    Time frame: 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-).

  6. Cardiometabolic health - fasting high-density lipoprotein cholesterol

    Time frame: 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-).

  7. Cardiometabolic health - fasting low-density lipoprotein cholesterol

    Time frame: 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-).

  8. Cardiometabolic health - fasting total cholesterol

    Time frame: 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-).

  9. Cardiometabolic health - fasting insulin

    Time frame: 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-).

  10. Cardiometabolic health - fasting glucagon-like peptide 1

    Time frame: 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-).

  11. Cardiometabolic health - fasting C-reactive protein

    Time frame: 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-).

  12. Cardiometabolic health - 24-hour glucose

    Time frame: 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-).

  13. Cardiometabolic health - glucose incremental area under the curve

    Time frame: 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-).

  14. Cardiometabolic health - glucose area under the curve

    Time frame: 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-).

  15. Cardiometabolic health - glucose standard deviation

    Time frame: 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-).

  16. Cardiometabolic health - glucose coefficient of variation

    Time frame: 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-).

  17. Cardiometabolic health - glucose time in range

    Time frame: 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-).

Study contacts

Contact information is provided by the study sponsor or research team.

Kaja Falkenhain, PhD

CONTACT

[email protected]

225-763-2558

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Interindividual Variability in the Effect of Premeal Almond Supplementation on Glycemic Control - a Double Crossover Study

Acronym: NUTS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 22, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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