NCT03227874

Effects of Dried Apple on Metabolic Responses

Completed NA Last updated 24 July 2017

What this trial tests

NA trial testing Dried apple in Healthy Individual in 21 participants. Completed in 29 January 2016.

Timeline

23 September 2015

Primary endpoint
6 November 2015

29 January 2016

Quick facts

Lead sponsor	San Diego State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	21
Start date	23 September 2015
Primary completion	6 November 2015
Estimated completion	29 January 2016
Sites	1 location across United States

Drugs / interventions tested

• Dried apple
• Muffin

Conditions studied

• Healthy Individual — all drugs for Healthy Individual →

Sponsor

San Diego State University

Who can join

Adults 20 to 45, any sex, with Healthy Individual. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Metabolic syndrome is a combination of metabolic comorbidities associated with obesity, which include impaired glucose tolerance and regulation, hypertension, dyslipidemia, and increased cardiovascular disease risk. Metabolic syndrome is highly prevalent with the growing trend of obesity that characterizes the US, with 34% of adults 20 years of age and older meeting the criteria. The number of people with diabetes is expected to increase dramatically over the next decades, coinciding with rising obesity rates in many countries. Recent studies have highlighted the beneficial effects of apple and apple products in reducing the risk of chronic disease due to their rich content of fiber, nutrients and various phytochemicals. The primary objective of the proposed research is to determine the acute effect of consumption of 240 kcal servings of dried apples versus a lowfat/high fiber muffin on blood glucose, serum insulin, and fullness (satiety). The secondary objective of the proposed research is to determine the acute effect of consumption of dried apple versus a low-fat muffin on various cognitive domains. As with any organ, the brain requires nutrients to build and maintain its structure and function, in order to perform in a harmonious manner and avoid damage from aging. Epidemiological, clinical and basic research studies suggest protective effects of several classes of nutrients against cognitive decline and risk of dementia. Twenty five male and female participants between the ages of 20-45 years with a body mass index (BMI) between 18 and 25 will be recruited to participate in the study at San Diego State University. Each participant will consume both test foods, the dried apple and muffin, on two separate visits to the lab at least a week apart. The participants will come to each lab visit after a 10 hour overnight fast. After arriving at the laboratory, the participant's will complete a cognitive pre-test (Concussion Vital Signs Test Battery) consisting of eight short cognitive tests on a computer. Next After arriving at the lab, blood samples will be collected from warmed hands by finger-prick into large (250 microliter) heparinized Natelson tubes to obtain an ample blood collection for analysis of baseline plasma concentrations of glucose and insulin. The participants will then be given 5 minutes to consume the test food. Subsequent finger-prick blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes. The participants will also rate their feelings of fullness on a visual scale prior to consumption of the test food and every 15 minutes for two hours after consumption. After the completion of the finger-prick blood samples and satiety questionnaires the participants will complete a cognitive post-test which will be a different version of the cognitive pre-test battery. Concentrations of glucose will be assessed by a handheld glucose monitor as well as an enzymatic kit. Insulin will be assessed by ELISA or radioimmunoassay. Differences in all dependent variables between the trials will be determined using a repeated measures ANOVA and followed post-hoc when appropriate using paired T-tests to take advantage of the higher statistical power provided by paired comparisons. Data will be reported as means +/- SD. Significance will be selected at an alpha level of P \< 0.05. These data may be useful as finding a snack source that produces a lower glycemic response and a greater satiating effect could be valuable in dietary counseling for blood glucose maintenance. For the cognitive portion of this research, these data may be useful because there is considerable room for improvement and for expanding evidence-based knowledge on the link between nutrition and cognition.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.