Eating Almonds Before a Meal to Control Blood Sugar

NCT07603739 | Not Yet Recruiting

• 1 other identifier: PBRC 2026-009
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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. 1.Does eating almonds before a meal reduce the rise in blood sugar after eating?
2. 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Postprandial glucose assessed during acute meal test

  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.

Secondary Outcomes (2)

• Interindividual variability in the postprandial glucose assessed during acute meal test

  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

  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

Other Outcomes (17)

• Acute postprandial glucose

  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

  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

  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.

Study Arms (8)

Randomization Sequence 1

EXPERIMENTAL

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).

Dietary Supplement: Premeal almond ingestion

Randomization Sequence 2

EXPERIMENTAL

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).

Dietary Supplement: Premeal almond ingestion

Randomization Sequence 3

EXPERIMENTAL

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).

Dietary Supplement: Premeal almond ingestion

Randomization Sequence 4

EXPERIMENTAL

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).

Dietary Supplement: Premeal almond ingestion

Randomization Sequence 5

EXPERIMENTAL

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).

Dietary Supplement: Premeal almond ingestion

Randomization Sequence 6

EXPERIMENTAL

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).

Dietary Supplement: Premeal almond ingestion

Randomization Sequence 7

EXPERIMENTAL

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).

Dietary Supplement: Premeal almond ingestion

Randomization Sequence 8

EXPERIMENTAL

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).

Dietary Supplement: Premeal almond ingestion

Interventions

Premeal almond ingestion DIETARY_SUPPLEMENT

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

Randomization Sequence 1; Randomization Sequence 2; Randomization Sequence 3; Randomization Sequence 4; Randomization Sequence 5; Randomization Sequence 6; Randomization Sequence 7; Randomization Sequence 8

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Hyperglycemia

Central Study Contacts

Kaja Falkenhain, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Model Details: The study consists of two phases using a crossover interventional design. In Phase 1, participants complete two cross-over trials (i.e., a total of four acute visits), including twice with an almond preload (active condition) and twice without (control condition). In Phase 2, participants complete one cross-over trial (i.e., a total of two 10-day study periods), including one with an almond preload prior to each meal (active condition) and one without (control condition). Given the repeated crossover nature of Phase 1 and the single crossover nature of Phase 2 of the study, there are a total of 8 possible visit sequences (i.e., "arms").

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)