Thermic Effect of Three Different Meals in Healthy Women

NCT04440826 | Completed

• 1 other identifier: 1502-441
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will investigate the acute effect of three isocaloric meals varying in level of food processing, including a whole foods, gluten-free, and highly processed meal on energy metabolism and blood glucose in 8-12 young adult, normal weight females. A secondary aim of this proposed study is to compare palatability, satiety, and perceived energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals.

Conditions

Weight Loss; Obesity

Outcome Measures

Primary Outcomes (1)

• Thermic Effect of Meals (TEM) also known as Postprandial Thermogenesis

  The total amount of calories burned after each meal will be measured using indirect calorimetry with the ventilated hood technique. Specifically, the thermic effect of each meal will be measured for a total of three hours at 45 minute intervals for 15 minutes at a time (45-60; 105-120; and 165-180 minutes)

  TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion

Secondary Outcomes (4)

• Blood Glucose Response

  Baseline line 0 minutes, and 60, 120, 180 minutes postprandial

• Change in Hunger and Palatability Scores and Energy Level

  Baseline 0 minutes, and 60, 120, 180 minutes postprandial

• Heart Rate

  Baseline 0 minutes, 60, 120, and 180 minutes postprandial

• Blood Pressure

  Baseline 0 minutes, 60, 120, and 180 minutes postprandial

Study Arms (3)

Whole Food Meal

ACTIVE COMPARATOR

Whole foods meal - grilled cheese and drink meal

Other: Whole Food Meal

Processed Food Meal

EXPERIMENTAL

Highly processed foods - grilled cheese and drink meal

Other: Processed Food Meal

Gluten-Free and Lactose-Free Meal

EXPERIMENTAL

Gluten-free and lactose-free foods - grilled cheese and drink meal

Other: Gluten-free and lactose-free

Interventions

Whole Food Meal OTHER

Whole foods meal

Whole Food Meal

Processed Food Meal OTHER

Processed food meal

Processed Food Meal

Gluten-free and lactose-free OTHER

Gluten-free and lactose-free food meal

Gluten-Free and Lactose-Free Meal

Eligibility Criteria

• Age: 18 Years - 24 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy females between the ages of 18 and 24 years that have BMIs that fall in the range of 18.5 kg/m2 to 28 kg/m2.

You may not qualify if:

• Those with a history of celiac disease or other food allergies, metabolic disease or heart disease.

Sponsors & Collaborators

• Skidmore College: lead

MeSH Terms

Conditions

Weight Loss; Obesity

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Mary Hoehn, MPH

  Skidmore College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 22, 2020
• Study Start: February 23, 2015
• Primary Completion: May 30, 2015
• Study Completion: May 30, 2015
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share