Effects of Dried Apple on Metabolic Responses

NCT03227874 | Completed

• 1 other identifier: 2040097
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Individual

Outcome Measures

Primary Outcomes (2)

• blood glucose response

  blood glucose using reagent

  Changes from 0 to 120 minutes after consumption of test food

• serum insulin response

  serum insulin using ELISA

  Changes from 0 to 120 minutes after consumption of test food

Secondary Outcomes (2)

• various cognitive domains

  baseline and two hour after test food consumption

• Satiety

  Changes from 0 to 120 minutes after consumption of test food

Study Arms (2)

Dried apple

EXPERIMENTAL

diced dried apple with 55 g carbohydrate, was consumed by the participants with 220 ml of water.

Dietary Supplement: Dried apple; Dietary Supplement: Muffin

Muffin

EXPERIMENTAL

two muffins, each with 55 g carbohydrate, was consumed by the participants with 220 ml of water.

Dietary Supplement: Dried apple; Dietary Supplement: Muffin

Interventions

Dried apple DIETARY_SUPPLEMENT

diced dried apple with 55 g carbohydrate, was consumed by the participants with 220 ml of water.

Dried apple; Muffin

Muffin DIETARY_SUPPLEMENT

two muffins with 55 g carbohydrate, was consumed by the participants with 220 ml of water.

Dried apple; Muffin

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 20-45 years
• body mass index (BMI; in kg/m2): 18-25.

You may not qualify if:

• past head injuries,
• cigarette smoking,
• pregnancy,
• allergies to test foods,
• chronic use of medications known to affect metabolism,
• presence of any disorder or medications affecting metabolism (e.g., diabetes, hyperthyroidism, phenylketonuria, obesity, glycogen storage diseases, etc.).

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (1)

San Diego State Univeristy

San Diego, California, 92182, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 24, 2017
• Study Start: September 23, 2015
• Primary Completion: November 6, 2015
• Study Completion: January 29, 2016
• Last Updated: July 24, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)