Eating Almonds Before a Meal to Control Blood Sugar (NUTS)
16. maj 2026 opdateret af: 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?
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
25
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Kaja Falkenhain, PhD
- Telefonnummer: 225-763-2558
- E-mail: kaja.falkenhain@pbrc.edu
Studiesteder
-
-
Louisiana
-
Baton Rouge, Louisiana, Forenede Stater, 70808
- Pennington Biomedical Research Center
-
Kontakt:
- Kaja Falkenhain, PhD
- Telefonnummer: 225-763-2558
- E-mail: kaja.falkenhain@pbrc.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postprandial glucose assessed during acute meal test
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Interindividual variability in the postprandial glucose assessed during acute meal test
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Acute postprandial glucose
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. marts 2028
Studieafslutning (Anslået)
1. juli 2028
Datoer for studieregistrering
Først indsendt
8. maj 2026
Først indsendt, der opfyldte QC-kriterier
16. maj 2026
Først opslået (Faktiske)
22. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PBRC 2026-009
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Data will be shared upon reasonable request to the study investigator and upon successful execution of a data transfer/sharing agreement.
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Kliniske forsøg med Ernæring
-
Duke UniversityAfsluttetBehandling og forebyggelse af anæmi efter administration af Gudness Nutrition BarIndien
Kliniske forsøg med Premeal almond ingestion
-
Guy's and St Thomas' NHS Foundation TrustKing's College London; Almond Board of CaliforniaIkke rekrutterer endnu
-
Virginia Polytechnic Institute and State UniversityRekruttering