Effects of Stevia on Satiety and Eating Attitudes in Healthy, Overweight and Obese Adults
This study has been completed.
Sponsor:
Pennington Biomedical Research Center
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01115088
First received: April 29, 2010
Last updated: May 3, 2010
Last verified: April 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity Type 2 Diabetes |
Dietary Supplement: Aspartame Dietary Supplement: Sucrose Dietary Supplement: Stevia |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) |
| Official Title: | Effects of Stevia on Satiety and Eating Attitudes in Healthy, Overweight and Obese Adults: A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Pennington Biomedical Research Center:
Primary Outcome Measures:
- Effects of stevia, aspartame, and sucrose on food intake, satiety, and postprandial glucose and insulin levels. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Hedonic ratings (appearance, aroma, flavor, texture and palatability)with Stevia sweetener compared to Sucrose or Aspartame [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Test whether preloads of tea and crackers with cream cheese sweetened with Stevia have different hedonic ratings compared to preloads of tea and crackers with cream cheese sweetened with Sucrose or Aspartame by examining hunger and satiety ratings after the preload.
- Satiating effects by examining food consumption [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]Test whether preloads of tea and crackers with cream cheese sweetened with stevia have different satiating effects compared to preloads of tea and crackers with cream cheese sweetened with Sucrose or Aspartame by examining food consumption 20 minutes and after lunch and dinner preloads, as well as total food consumption.
| Enrollment: | 30 |
| Study Start Date: | January 2006 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aspartame
Food or beverages containing Aspartame in comparison to Stevia or Sucrose
|
Dietary Supplement: Aspartame
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)
Other Name: equal sweetener
|
|
Experimental: Sucrose
Food or beverages containing Sucrose in comparison to Aspartame or Stevia
|
Dietary Supplement: Sucrose
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)
|
|
Experimental: Stevia
Food or beverages containing Stevia in comparison to Aspartame or Sucrose
|
Dietary Supplement: Stevia
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)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115088
Locations
| United States, Louisiana | |
| Pennington Biomedical Research Center | |
| Baton Rouge, Louisiana, United States, 70808 | |
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
| Principal Investigator: | Stephen D. Anton, PhD | Pennington Biomedical Research Center |
More Information
No publications provided
| Responsible Party: | Stephen Anton PhD / Principle Investigator, Pennington Biomedical Research Center |
| ClinicalTrials.gov Identifier: | NCT01115088 History of Changes |
| Other Study ID Numbers: | PBRC25030 |
| Study First Received: | April 29, 2010 |
| Last Updated: | May 3, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 2 Obesity Overweight Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Overnutrition Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013