NCT01115088

Brief Summary

The purpose of this study is to test the effects that three different types of sweeteners have on food intake, hunger and satiety levels, as well as insulin and glucose measures. The study of whether food or beverages containing Stevia influence food intake to a greater extent than food or beverages sweetened with Aspartame or Sucrose. Also, examining whether taste preference and taste sensitivity influence food intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

4.2 years

First QC Date

April 29, 2010

Last Update Submit

February 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effects of stevia, aspartame, and sucrose on food intake, satiety, and postprandial glucose and insulin levels.

    Test whether preloads of tea and crackers with cream cheese sweetened with Stevia lover postprandial insulin levels compared to preloads of tea and crackers with cream cheese sweetened with Sucrose or Aspartame by measuring blood insulin and glucose levels immediately prior to the lunch preload,immediately before lunch test meal, and at thirty minutes, one hour, and two hours after the lunch test meal.

    24 hours

Secondary Outcomes (2)

  • Hedonic ratings (appearance, aroma, flavor, texture and palatability)with Stevia sweetener compared to Sucrose or Aspartame

    24 hours

  • Satiating effects by examining food consumption

    24 Hours

Study Arms (3)

Aspartame

EXPERIMENTAL

Food or beverages containing Aspartame in comparison to Stevia or Sucrose

Dietary Supplement: Aspartame

Sucrose

EXPERIMENTAL

Food or beverages containing Sucrose in comparison to Aspartame or Stevia

Dietary Supplement: Sucrose

Stevia

EXPERIMENTAL

Food or beverages containing Stevia in comparison to Aspartame or Sucrose

Dietary Supplement: Stevia

Interventions

AspartameDIETARY_SUPPLEMENT

The morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998)

Also known as: equal sweetener
Aspartame
SucroseDIETARY_SUPPLEMENT

The morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998)

Sucrose
SteviaDIETARY_SUPPLEMENT

The morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998)

Stevia

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy and have a body mass index \> 30 kg/m2 and \< 39.9 kg/m2, or have a body mass index \> 20 kg/m2 and \< 24.9 kg/m2
  • If BMI is between 30 and 39.9, waist circumference must be \> 36 for women and \> 40 for men.
  • Age 18 to 45 years
  • Nonsmokers
  • Willing to consume meat products
  • Women on monophasic oral contraceptives or who have physiologically controlled cycles

You may not qualify if:

  • A history of diabetes, cardiovascular disease, or other chronic illnesses
  • Presence of an eating disorder including Anorexia and/or Bulimia Nervosa
  • Other health problems that might interfere with your ability to participate in the study
  • Taking medications, other than monophasic birth control or monophasic (same dose every day) hormone replacement therapy and allergy medication
  • Taking allergy medication for a period of time less than 6 months
  • Dislike of or allergy to foods/sweeteners (Sucrose, Stevia, or Aspartame) used in test meals
  • Smokers
  • High scores on the Dietary Restraint, Disinhibition, and Perceived Hunger scales of the Three Factor Eating Questionnaire
  • Use of oral contraceptives other than monophasic (same dose every day) contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Interventions

AspartameSucrosestevioside

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Stephen D. Anton, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

April 29, 2010

First Posted

May 4, 2010

Study Start

January 1, 2006

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations