Clinical trial NCT01684332: Postprandial Response to Different Jams
Official title: Study of the Effects of Three Strawberry Jams, Differing in Carbohydrate and Antioxidant Content, on Postprandial Response in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial
Hyperglycemia, Postprandial
Feeding Behaviors
Antioxidant
Lipid Profile
Keywords: Antioxidant
glucose metabolism
jam
polyphenols
postprandial
strawberry
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effects of an acute intake of three different types of strawberry jam, differing in the carbohydrates and antioxidants content, on postprandial glucose metabolism, lipid profile, antioxidant status and satiety indices, in healthy adults.

Detailed description: Study Design: Randomized, postprandial, crossover, double-blind intervention with three arms.

Subjects: Sixteen healthy adults

Product studied: At each arm, participants consume 60g of strawberry jam:

* High-sugar jam (traditional; HS),
* Low-sugar jam (without added-sugar; LS),
* Low-sugar jam including antioxidant extract from strawberry pulp (LSA).

Eligibility criteria: Inclusion Criteria:

* Adult men and women
* Normal weight or overweight (BMI between 18.5 and 29.9 kg/m2)
* Age between 20 and 50 years old.

Exclusion Criteria:

* To suffer from any chronic disease related to metabolism,
* To follow concomitant medications,
* To follow slimming treatments or hormone replacement therapy,
* To have any inability to perform the follow-up,
* Smoking,
* Known food allergies,
* Pregnancy, lactation or menopause

Primary outcomes:
measure: Plasma malondialdehyde (MDA) postprandial measure
timeFrame: up to 120 minutes
Secondary outcomes:
measure: Serum glucose postprandial concentration
timeFrame: Baseline, 30, 60, 90 and 120 minutes
measure: Serum insulin postprandial concentration
timeFrame: baseline, 30, 60, 90 and 120 minutes
measure: HOMA insulin resistance index
timeFrame: Baseline, 30, 60, 90 and 120 minutes
measure: Serum total cholesterol postprandial concentration
timeFrame: Baseline, 30, 60, 90 and 120 minutes
measure: Serum HDL-cholesterol postprandial concentration
timeFrame: Baseline, 30, 60, 90 and 120 minutes
measure: Serum LDL-cholesterol postprandial concentration
timeFrame: Baseline, 30, 60, 90 and 120 minutes
measure: Serum Uric Acid postprandial concentration
timeFrame: Baseline, 30, 60, 90 and 120 minutes
measure: Plasma Glutathione Peroxidase postprandial activity
timeFrame: Baseline, 30, 60, 90 and 120 minutes
measure: Postprandial Plasma Total Antioxidant Capacity
timeFrame: Baseline, 30, 60, 90 and 120 minutes
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Department of Nutrition, Food Science and Physiology
state: Navarra
Study officials:
affiliation: University of Navarra
name: J. Alfredo Martínez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Navarra
name: M. Ángeles Zulet, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Marta Cuervo, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Santiago Navas-Carretero, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Idoia Ibero-Baraibar, MsC
role: STUDY_CHAIR
References:
citation: Ibero-Baraibar I, Cuervo M, Navas-Carretero S, Abete I, Zulet MA, Martinez JA. Different postprandial acute response in healthy subjects to three strawberry jams varying in carbohydrate and antioxidant content: a randomized, crossover trial. Eur J Nutr. 2014 Feb;53(1):201-10. doi: 10.1007/s00394-013-0517-7. Epub 2013 Apr 4.