Clinical trial NCT01413126: Peanuts Second Meal Glycemic Response
Official title: Acute and Second Meal Effects of Peanuts on Glycemic Response and Appetite in Obese Women With High Type 2 Diabetes Risk: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Peanut
Blood glucose
Insulin
Non-esterified free fatty acids
Glucagon-like peptide-1
Peptide YY
Cholecystokinin
Appetitive
Food intake
Lead sponsor: Federal University of Vicosa
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
name: United States Agency for International Development (USAID)
First posted: 2011-08-10
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Nut consumption is associated with reduced risk of Type 2 diabetes. The aim of this study was to assess the effects of peanut (whole or peanut butter) to breakfast meals on glycemic, insulinemic and selected gut hormone responses, appetite, and food intake over two consecutive meals in obese women with high Type 2 diabetes risk. Fifteen women participated in a randomized crossover trial 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. Postprandial concentrations of blood glucose, insulin, non-esterified free fatty acids (NEFA), glucagon-like peptide-1 (GLP-1), peptide YY (PYY), cholecystokinin (CCK), appetitive sensations and food intake were assessed after breakfast treatments and a standard lunch (75g available carbohydrate).


Eligibility criteria: Inclusion Criteria:

* 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 mellitus
* Dyslipidemia
* High blood pressure

Primary outcomes:
measure: Change from baseline in glucose homeostasis at eight hours
timeFrame: Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430 and 490 minutes
Secondary outcomes:
measure: Change from baseline in incretin hormones at four hours
timeFrame: Baseline (-10), 15, 45, 60, 90, 120, 180 and 240 minutes
measure: Change in food intake over 24 hours
timeFrame: 24 hours
measure: Change from baseline in appetitive sensations at twelve hours
timeFrame: Baseline (-10), 15, 45, 60, 90, 120, 180, 240, 265, 295, 310, 340, 370, 430, 490, 550, 610, 670 and 730 minutes
Other outcomes:
Locations:
city: Viçosa
country: Brazil
facility: Federal University of Viçosa
state: Minas Gerais
Study officials:
affiliation: University of Brasília, Brazil
name: Caio EG Reis, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Viçosa, Brazil
name: Daniela N Ribeiro, M.Sc.
role: STUDY_CHAIR
affiliation: Federal University of Espírito Santo, Brazil
name: Neuza MB Costa, Ph.D.
role: STUDY_CHAIR
affiliation: Federal University of Viçosa, Brazil
name: Josefina Bressan, Ph.D.
role: STUDY_CHAIR
affiliation: Federal University of Viçosa, Brazil
name: Rita CG Alfenas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Purdue University
name: Richard D Mattes, Ph.D.
role: STUDY_DIRECTOR
References: