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Eating Almonds Before a Meal to Control Blood Sugar (NUTS)

15 juli 2026 bijgewerkt door: 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:

  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?

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

25

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Louisiana
      • Baton Rouge, Louisiana, Verenigde Staten, 70808
        • Werving
        • Pennington Biomedical Research Center
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Voedingssupplement: Premeal almond ingestion
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
Experimenteel: 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).
Voedingssupplement: Premeal almond ingestion
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
Experimenteel: 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).
Voedingssupplement: Premeal almond ingestion
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
Experimenteel: 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).
Voedingssupplement: Premeal almond ingestion
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
Experimenteel: 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).
Voedingssupplement: Premeal almond ingestion
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
Experimenteel: 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).
Voedingssupplement: Premeal almond ingestion
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
Experimenteel: 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).
Voedingssupplement: Premeal almond ingestion
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
Experimenteel: 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).
Voedingssupplement: Premeal almond ingestion
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postprandial glucose assessed during acute meal test
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Interindividual variability in the postprandial glucose assessed during acute meal test
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Acute postprandial glucose
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pennington Biomedical Research Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 juni 2026

Primaire voltooiing (Geschat)

1 maart 2028

Studie voltooiing (Geschat)

1 juli 2028

Studieregistratiedata

Eerst ingediend

8 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 mei 2026

Eerst geplaatst (Werkelijk)

22 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

15 juli 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PBRC 2026-009

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Data will be shared upon reasonable request to the study investigator and upon successful execution of a data transfer/sharing agreement.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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