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Completed

NCT Number: NCT05010408

Liking Adaptation to Beverages of Varying Sweetness Levels Following Prolonged Exposure

This is a double-blind, controlled, parallel, randomized sensory study. The study will consist of two cohorts; habitual regular full-calorie Carbonated Soft Drink (CSD) consumers and habitual low-calorie CSD consumers. Each cohort will be randomized to one of 3 interventions for six months (24 weeks):

* Intervention 1: Control (full sweetness) beverage * Intervention 2: Step-wise sweetness reduction series of beverages * Intervention 3: Moderate sweetness (reduced sweetness) beverage

The primary outcome is to assess the perception changes in sweetness (magnitude scale) and sweetness liking (Likert scale) of a test product and a control product over a period of six months. The study endeavors to explore whether consumers of sweetened carbonated beverages can adapt liking to lower sweetness beverages after prolonged exposure of daily consumption of beverages with step-wise reduction of sweetness, or maintenance at reduced (moderate) sweetness.

Additional analysis will be to assess dietary compensation for sweetness in the step-wise and moderate reduction arms compared to the control arms (the full calorie and low calorie control beverages). Dietary analysis of calories and intakes of total sugar, added sugar, and servings of low-/non-calorie sweeteners will be assessed using a 3-day diet record pre-intervention and monthly for 6 months.

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Key information

Conditions

Sweetness Liking Adaptation

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mérieux NutriSciences (MXNS), Electrón No. 28, Parque Industrial Cition

Mexico City, Naucalpan De Juárez, C.P. 53470, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults 25-55 years of age
  • Habitually consume regular or diet CSD
  • Willing and able to consume at least one orange CSD beverage daily for a total of 6 months and abstain from other sweetened beverages
  • Willing and able to complete questionnaires regarding dietary intake and sensory perception
  • Has internet access via computer, phone or other device and is able to maintain internet access throughout the trial in order to complete daily online questionnaires.
  • Participant is judged to be in good health based on a verbal health query and the general health and lifestyle questionnaire.
  • Participant is willing to maintain his or her habitual diet, smoking habits and physical activity patterns, including habitual use of study approved medications and/or dietary supplements throughout the study period.
  • Participant understands the study procedures and signs forms providing informed consent to participate in the study.

Exclusion criteria

  • Regular smoker (more than 1 cigarette per week)
  • History or presence of type 1 or 2 diabetes mellitus
  • Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet, gluten-free, low-carb, vegan, ketogenic, and intermittent fasting (defined as intentional fasting for longer than 16 hours or alternate day fasting)
  • Extreme changes to physical activity
  • Females who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
  • Recent history (within 12 months of screening; Visit 1) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
  • Individual has a condition that would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the participant at undue risk.
  • Dislike of citrus flavored CSDs
  • Participation in another clinical trial within past 30 days
  • People who have phenylketonuria (low calorie sweetened beverages contain aspartame)

Treatment and study plan

Flavored carbonated soft drink (CSD) at different sweetness levels

Other

Beverage

Primary outcomes

  1. Sweetness liking

    Time frame: Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6

    Likert Scale, 9 point scale from 1=Dislike extremely to 9=Like extremely, to explore adaptation to lower sweetness beverages after prolonged exposure of daily consumption of beverages with step-wise reduction of sweetness versus maintenance at reduced (moderate) sweetness. Adaptation is better than no adaptation, and faster adaptation is better than slower adaptation.

  2. Sweetness intensity perception

    Time frame: Time Frame: Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6

    Magnitude scale ranging from barely perceptible to strongest imaginable sweetness, to explore sweetness intensity perception over prolonged exposure to daily consumption of beverages of varying sweetness levels at either step-wise reduction of sweetness or maintenance at reduced (moderate) sweetness.

Other outcomes

  1. Dietary compensation for sweetness

    Time frame: Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6

    3-day diet record to assess calories and intake of total sugar, added sugar, low-/non calorie sweeteners 3-day diet record to assess calories and intake of total sugar, added sugar, low-/non calorie sweeteners 3-day diet record to assess calories and intake of total sugar, added sugar, low-/non calorie sweeteners

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2021
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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