Recruiting

Almonds

Sponsor:

Pennington Biomedical Research Center

Code:

NCT07603739

Conditions

Glucose Control

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Precision Medicine

Nutrition

Eligibility Criteria

Sex: All

Age: 25 - 50

Healthy Volunteers: Accepted

Interventions

Premeal almond ingestion

Study Details

Brief summary:

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?

Conditions

Glucose Control

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Precision Medicine

Nutrition

Study ID

NCT07603739

Start date

Jun 23, 2026

Status verified date

May, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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).

experimental: 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).

experimental: 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).

experimental: 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).

experimental: 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).

experimental: 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).

experimental: 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).

experimental: 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).

Interventions

Premeal almond ingestion

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Kaja Falkenhain, PhD

225-763-2558kaja.falkenhain@pbrc.edu

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Kaja Falkenhain, PhD

225-763-2558kaja.falkenhain@pbrc.edu

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Jul 17, 2026

Last verified

May, 2026

Keywords

  • Nutrition
  • Precision Medicine
  • Precision Nutrition
  • Glucose Control
  • Impaired Glucose Tolerance
  • Insulin Resistance
  • Prediabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2026-07-17.