NCT02090478

Brief Summary

The purpose of the study is to determine how reducing the amount of simple sugars in the diet affects sweet taste perception. Healthy adult subjects will be assigned to either follow their usual diet, or to replace sugar calories with fats or starch. The investigators hypothesize that eating less sugar will:

  1. 1.cause foods and drinks with a given amount of sugar to taste sweeter
  2. 2.cause people to prefer lower levels of sugar in foods and drinks

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

8 months

First QC Date

March 13, 2014

Last Update Submit

March 14, 2014

Conditions

Sweet Taste Perception

Outcome Measures

Primary Outcomes (2)

  • Change in Sweet Taste Intensity over Five Months

    Subjects rated the sweetness of pudding and beverage samples that varied in sucrose concentration during each study month to determine how perception changes over time with diet manipulations

    Monthly (for five months)

  • Change in Pleasantness Over Five Months

    Subjects rated hedonic value (degree to which the sample was pleasant) for model pudding and beverages that differed in concentration of sucrose once each month over five months to determine how perception changed over time with the diet manipulation

    Monthly (five month participation duration total)

Secondary Outcomes (3)

  • Sucrose detection thresholds

    Every month (for five months)

  • Body mass index

    Every month (five months total)

  • Diet records

    Every month (five month total)

Study Arms (2)

No change in dietary sugar levels

SHAM COMPARATOR

Group met with a dietician as often as the control group to discuss diet, but the dietician gave them advice geared toward no change in dietary sugar levels

Other: Sham diet manipulation

Low sugar group

EXPERIMENTAL

Subjects met with a dietician who discussed diet records. After the first month (baseline, regular diet), the dietician made suggestions geared toward reducing calories from simple sugars by 40%. This will be achieved by replacing sugar calories with complex carbohydrates and fats, while maintaining energy balance (same number of calories as the baseline month).

Other: Low sugar diet

Interventions

Low sugar dietOTHER

All subjects followed their usual diet during month 1. For months 2-4: sham diet intervention for the control group, 40% reduction in sugar calories for the experimental group. All subjects were allowed to chose any diet they wished during month 5.

Low sugar group
Sham diet manipulationOTHER

Subjects in the control group will meet with a dietician and discuss diet records, but the dietician will not instruct the control subjects to reduce the number of calories from simple sugars in the diet

No change in dietary sugar levels

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good general heath (by self report)
  • Consume at least 2 sugar-containing soft drinks/day on average)
  • Able to control diet (select their own foods)

You may not qualify if:

  • Major illness of any kind within the last six months, or any chronic illness
  • Daily use of medication, except for birth control, vitamins, and aspirin
  • Regularly consume non-nutritive sweeteners
  • Pregnant women
  • Gained or lost 10% or more of their body weight in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19014, United States

Location

Related Publications (1)

  • Wise PM, Nattress L, Flammer LJ, Beauchamp GK. Reduced dietary intake of simple sugars alters perceived sweet taste intensity but not perceived pleasantness. Am J Clin Nutr. 2016 Jan;103(1):50-60. doi: 10.3945/ajcn.115.112300. Epub 2015 Nov 25.

    PMID: 26607941DERIVED

Study Officials

  • Paul M Wise, PhD

    Monell Chemical Senses Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Member

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 18, 2014

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

US(1)