Acute Amino Acid Response of Proprietary Beverages

ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorShaklee Corporation

About this trial

The primary objective of this study is to evaluate post-meal amino acid in response to a proprietary beverages in generally healthy adults.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males and females, ≥20 to ≤50 years of age.

Body mass index (BMI( ≥18.5 and <25.0 kg/m2.

Self-reported regular consumer (≥5 days/week) of breakfast.

Women who are either pre- or post-menopausal. Premenopausal women that are not using hormonal contraceptives must have a history of regular menstrual cycles (21-35 d per cycle or at the investigator's discretion) for at least 3 months prior.

Disqualifiers

Is currently following, or planning to be on, a weight loss regimen at any time prior to or during the study.

Weight loss or gain >4.5 kg within 90 days.

History of gastrointestinal surgery for weight reducing purposes.

History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) or extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian) at the discretion of the Clinical Investigator.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Test carbonated protein beverage

    Other intervention

    Participants will consume a carbonated test protein beverage

  • Test protein beverage

    Other intervention

    Participants will consume a beverage that contains a test protein.

  • Control protein beverage.

    Other intervention

    Participants will consume a beverage that contains a control protein.

  • Control non-carbonated beverage

    Other intervention

    Participants will consume a non-carbonated beverage that contains a test protein.

Treatment groups

24 Participants
are divided into 4 treatment groups
Group A: Test protein beverage followed by Control protein beverageExperimental treatment 2 interventions
Group B: Control protein beverage followed by Test protein beverageExperimental treatment 2 interventions
Group C: Test carbonated protein beverage followed by Control non-carbonated protein beverageExperimental treatment 2 interventions
Group D: Control non-carbonated protein beverage followed by Test carbonated protein beverageExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum concentration (Cmax) above baseline for essential amino acids

Time frame
Up to 2 hours post-beverage consumption

Secondary outcomes

1

Positive area under the curve (AUC) for essential amino acids

Time frame
Up to 2 hours post-beverage consumption
2

Time to Cmax (Tmax) for essential amino acids

Time frame
Up to 2 hours post-beverage consumption
3

Maximum concentration (Cmax) above baseline for appetite hormones

Time frame
Up to 2 hours post-beverage consumption
4

Positive area under the curve (AUC) for appetite hormones

Time frame
Up to 2 hours post-beverage consumption

Other outcomes

Sponsors and contacts

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

Shaklee Corporation

Lead sponsor

Biofortis Clinical Research, Inc.

Collaborator

Nlumn LLC

Collaborator