Health TrialsbyHealthPanel

A1-Free vs. Conventional Milk Metabolic Response Study

ConditionsPostprandial Glucose ResponseInsulin ResponseLactose DigestionPostprandial Metabolism
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPurdue University

About this trial

This study will examine how different types of milk affect blood sugar and insulin responses after eating. Specifically, the study compares milk that contains only A2 beta-casein protein (A1-free milk) to conventional milk, which contains both A1 and A2 proteins.

Participants will complete four study visits in which they will consume different milk-based beverages. These include lactose-containing milk and lactose-free milk followed by a lactose drink given later. Blood samples will be collected over several hours to measure glucose and insulin responses. Breath tests and questionnaires will also be used to assess digestion and gastrointestinal symptoms.

The goal of this study is to determine whether milk protein type influences metabolic responses and whether consuming lactose-free milk affects how the body processes lactose when it is consumed later.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ability/desire to provide informed consent

Are between 18 and 65 years of age

Are generally healthy, with no known metabolic or gastrointestinal conditions that would affect digestion or metabolism

Are willing to consume milk-based beverages and lactose-containing drinks as part of the study

Disqualifiers

You have a known allergy to milk or dairy products

You are currently pregnant, planning to become pregnant, or breastfeeding

You currently smoke or have used tobacco or nicotine-containing products within the past 3 months

You have a history of excessive alcohol use within the past 30 days

Trial design

Design model

Crossover

Treatments tested in this trial

  • Lactose-Containing A1-Free Milk

    Dietary supplement

    A lactose-containing milk beverage containing A2 beta-casein and no A1 beta-casein, consumed during one experimental study visit.

  • Lactose-Containing Conventional Milk

    Dietary supplement

    A lactose-containing conventional milk beverage containing both A1 and A2 beta-casein, consumed during one experimental study visit.

  • Lactose-Free A1-Free Milk With Delayed Lactose Drink

    Dietary supplement

    A lactose-free A1-free milk beverage consumed at the start of the study visit, followed by a lactose drink administered 60 minutes after milk consumption. The lactose drink is matched to the amount of lactose expected in the milk serving.

  • Lactose-Free Conventional Milk With Delayed Lactose Drink

    Dietary supplement

    A lactose-free conventional milk beverage containing both A1 and A2 beta-casein consumed at the start of the study visit, followed by a lactose drink administered 60 minutes after milk consumption. The lactose drink is matched to the amount of lactose expected in the milk serving.

Treatment groups

35 Participants
are divided into 4 treatment groups
Group A: Lactose-Containing A1-Free MilkExperimental treatment 1 intervention
Group B: Lactose-Containing Conventional MilkExperimental treatment 1 intervention
Group C: Lactose-Free A1-Free Milk With Delayed Lactose DrinkExperimental treatment 1 intervention
Group D: Lactose-Free Conventional Milk With Delayed Lactose DrinkExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postprandial Plasma Insulin Incremental Area Under the Curve (iAUC)

Incremental area under the curve (iAUC) for plasma insulin concentrations following consumption of each study condition, measured from serial blood samples collected via an indwelling catheter.

Time frame
0 to 180 minutes post-intervention during each study visit
2

Postprandial Plasma Glucose Incremental Area Under the Curve (iAUC)

Incremental area under the curve (iAUC) for plasma glucose concentrations following consumption of each study condition, measured from serial blood samples collected via an indwelling catheter.

Time frame
0 to 180 minutes post-intervention during each study visit

Secondary outcomes

1

Early-Phase Postprandial Glucose and Insulin Response

Early-phase postprandial response assessed by incremental area under the curve (iAUC) for plasma glucose and insulin concentrations.

Time frame
0 to 60 minutes post-intervention
2

Time to Peak Plasma Glucose and Insulin Concentrations (Tmax)

Time required to reach peak plasma glucose and insulin concentrations following each study condition.

Time frame
0 to 180 minutes post-intervention
3

Circulating Metabolite Responses

Postprandial changes in circulating metabolites, including amino acids and acylcarnitines, measured from plasma samples to assess metabolic responses.

Time frame
0, 30, 60, and 120 minutes
4

Breath Hydrogen Concentrations

Breath hydrogen levels measured as a non-invasive marker of carbohydrate fermentation and lactose maldigestion.

Time frame
Baseline and every 30 minutes from 0 to 180 minutes post-intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Purdue University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: