|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
REBEC |
|
Last refreshed on:
|
27 May 2013 |
|
Main ID: |
RBR-3d9kqb |
|
Date of registration:
|
29/06/2011 |
|
Primary sponsor: |
|
|
Public title:
|
Effect of peanut in appetite and diabetes risk
|
|
Scientific title:
|
Acute and second meal effects of peanuts on glycemic response and appetite in obese women a randomized crossover trial |
|
Date of first enrolment:
|
|
|
Target sample size:
|
15 |
|
Recruitment status: |
data analysis completed |
|
URL:
|
http://www.ensaiosclinicos.gov.br/rg/RBR-3d9kqb/ |
|
Study type:
|
Intervention |
|
Study design:
|
Open-Label, Randomized, Crossover, phase II, 3-Arm, clinical trial
|
|
|
Countries of recruitment
|
|
Brazil
| | | | | | | |
|
Contacts
|
|
Name:
|
Rita
Alfenas |
|
Address:
|
Department of Nutrition and Health, Federal University of Viçosa, Brazil
36570000
Viçosa
Brazil |
|
Telephone:
|
+55 31 38993740 |
|
Email:
|
ralafenas@ufv.br |
|
Affiliation:
|
Universidade Federal de Viçosa |
|
|
Name:
|
Caio
Reis |
|
Address:
|
Faculty of Health Sciences, University of Brasilia, Brazil
70910-900
Brasília
Brazil |
|
Telephone:
|
+55 61 33072193 |
|
Email:
|
caioedureis@gmail.com |
|
Affiliation:
|
Universidade de Brasília |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Age 18 - 60 years, body mass index between 30 - 35 kg/m2, not taking medications known to affect glycemia, fat metabolism, or appetite; regular breakfast consumer (?100 kilocalories ingested within 2 hours of waking on ?4d/wk); no body weight fluctuation (<5kg in the past 3 months); willingness to eat all test foods; no self-reported allergy to the foods provided in the study; no self-reported sleep disorders; at least one of the following conditions: waist circumference ? 88 cm; reported family history of type 2 diabetes in first degree relatives; capillary glycemia between 5.5 – 7.0 mmol/L; and/or a 2-hour blood glucose of 7.8 – 11.1 mmol/L (impaired glucose tolerance).
Exclusion criteria: Type 2 diabetes, dyslipidemia or high blood pressure.
Age minimum:
18Y
Age maximum:
60Y
Gender:
F
|
|
Health Condition(s) or Problem(s) studied
|
|
E00-E90
|
Impaired glucose tolerance, Type 2 diabetes mellitus, Obesity
C18.654.726.500
C18.452.394.952.500
|
|
Intervention(s)
|
|
Fifteen obese women with high type 2 diabetes risk participated in a randomized crossover trial lasting 8 hours where 42.5g of whole peanuts (P), peanut butter (PB), or no peanuts (control - C) were added to a 75g available carbohydrate-matched breakfast meal.
|
|
Primary Outcome(s)
|
|
Improvement on glucose homeostasis (Glucose, insulin and free fatty acids)
|
|
Secondary Outcome(s)
|
|
Higher concentration of Glucagon-like peptide-1 , cholecystokinin and Peptide YY; Increase satiety; Reduction of food intake.
|
|
Source(s) of Monetary Support
|
|
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brazil
|
|
Fundação de Amparo à Pesquisa do Estado de Minas Gerais - Brazil
|
|