Development of a Marker of Adherence for Tracking Consumption of Nutrient Supplements

University of California (UC) Davis

Status: Completed

Conditions: Adherence, Treatment

Treatments: Dietary Supplement: lipid-based nutrient supplement not containing adherence markers; Dietary Supplement: lipid-based nutrient supplement containing or not containing adherence markers; Dietary Supplement: lipid-based nutrient supplement containing adherence markers

Study type: Interventional

Funder types: Other

Identifiers

NCT04040543

1410234

Details and patient eligibility

About

The purpose of this study is to determine whether selected adherence markers can be used to track daily or intermittent consumption of nutrient supplements.

Full description

The investigators will assess whether urinary concentrations of selected adherence markers can be used to distinguish between daily or intermittent consumption of lipid-based nutrient supplements.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• non-pregnant, non-lactating women

Exclusion criteria

• BMI <18.5kg/m2 or >25.0 kg/m2
• Diagnosis of chronic disease
• Use of medication that can affect gastrointestinal mobility
• Consumption of more than 7 alcoholic drinks per week
• Smoking
• Unwillingness to refrain from consuming dietary sources of the marker compound(s) 3 days prior to, and during the 12 day urine collection period
• Unwillingness to adhere to the study protocol
• Peanut allergy
• Cow milk allergy
• Soy allergy
• Almond allergy
• Allergy to adherence markers
• Pregnancy

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups, including a placebo group

Daily

Experimental group

Description:

Daily supplementation with product containing markers

Treatment:

Dietary Supplement: lipid-based nutrient supplement containing adherence markers

Intermittent

Experimental group

Description:

Daily supplementation with either the product containing markers or the product not containing markers

Treatment:

Dietary Supplement: lipid-based nutrient supplement containing or not containing adherence markers

Control

Placebo Comparator group

Description:

Daily supplementation with product not containing markers

Treatment:

Dietary Supplement: lipid-based nutrient supplement not containing adherence markers