NCT03240757

Brief Summary

In the present study the investigators compared the hormonal and metabolic effects of three meal loads very popular among Italian eating habits, both in the resting- and exercising state. Given the lack of time is considered a common barrier to exercise adherence, we wanted to identify a low dose of exercise capable to produce health benefits in the post-absorptive status elicited by three commonly consumed meal-models in Mediterranean countries. To this end, healthy young volunteers firstly underwent an oral glucose tolerance test (OGTT) and three meal tolerance tests. Secondly, in an extra set of experiments, subjects cycled at low intensity for the last 20 minutes of the same glucose/meal tolerance test. Glycemia, insulinemia, ghrelinemia, lipidemia, and satiety were measured throughout OGTT and each test-meal load.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2010

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

August 1, 2017

Last Update Submit

August 4, 2017

Conditions

Keywords

meal absorptionexerciseenergy balancelipolysis

Outcome Measures

Primary Outcomes (4)

  • Plasma glucose responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.

    Postprandial glycemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.

    The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).

  • Plasma insulin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.

    Postprandial insulinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.

    The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).

  • Plasma ghrelin responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.

    Postprandial ghrelinemic responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.

    The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).

  • Plasma free fatty acids (FFA) responses of a single bout of low-intensity exercise following mixed meals in healthy individuals.

    Postprandial plasma FFA responses elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise.

    The entire study lasted for 9 experimental days (1 day for eligibility, 4 days for resting trial, 4 days for exercise trial).

Study Arms (2)

Breakfast without exercise

ACTIVE COMPARATOR

Each subject of the same arm underwent 2 interventions: breakfast with/without exercise

Dietary Supplement: Breakfast

Breakfast with exercise

EXPERIMENTAL

Each subject of the same arm underwent 2 interventions: breakfast with/without exercise

Dietary Supplement: BreakfastOther: exercise

Interventions

BreakfastDIETARY_SUPPLEMENT

All subjects received a standard 75-g OGTT to assess eligibility for the study. The 19 subjects matching the inclusion criteria completed 2 experimental trials: resting and exercise. During the resting trial, all subjects underwent an OGTT (50-g: A) and 3 meal tolerance tests \[one for each breakfast tested: B1 = milk (125ml) and cereals (30g); B2 = milk (220ml), apple (200g) and chocolate cream-filled sponge cake (30g); B3 = milk (125ml), apple (150g), bread (50g) and hazelnut chocolate cream (15g)\]. In the exercise trial, 100 minutes after the glucose/meal ingestion, participants cycled for 20 min at 40% of maximum oxygen uptake.

Breakfast with exerciseBreakfast without exercise

aerobic exercise at 40% of VO2max, for 20 minutes

Breakfast with exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 40 years
  • normal body weight (BMI =18.5 - 24.9 according to NHLBI)
  • stable diet

You may not qualify if:

  • Diabetes, tipe 1 and 2 (ADA criteria)
  • Glucose intolerance (ADA criteria)
  • Dyslipidemia (ATP III according to NCEP)
  • Metabolic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • R Codella, A Caumo, S Benedini, M Adamo, A Ferrulli, C Macrì, I Terruzzi, L Luzi. Metabolic responses of a single bout of low-intensity exercise following mixed meals in healthy individuals. ADA (American Diabetes Association) 77th Scientific Session, 8-13 giugno 2017, San Diego, CA, USA. Diabetes 2017 Jun; 66 (Supplement 1).

    RESULT

MeSH Terms

Conditions

Nutrition DisordersMotor Activity

Interventions

BreakfastExercise

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Livio Luzi, M.D.

    Gruppo San Donato

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized-crossover in healthy subjects
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Full Professor of Endocrinology

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 7, 2017

Study Start

July 14, 2009

Primary Completion

May 28, 2010

Study Completion

May 28, 2010

Last Updated

August 7, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

De-identified collective participant data for all outcome measures will be made available upon publication