NCT03164200

Brief Summary

Aging is associated with an increased risk for metabolic diseases, such as type 2 diabetes and cardiovascular disease. There is reason to believe that the time of day when specific food groups are eaten affects this risk. The investigators propose that eating foods made up of fat and protein (such as eggs) in the morning for breakfast, rather than foods made up of carbohydrates (such as white-bread toast or sugary cereal) may promote a healthier metabolism. This is because the body is designed to burn fat during times of fasting, such as overnight, during sleep. Thus, the body is not prepared to burn sugar early in the morning, when most people eat breakfast. Studies with mice have shown that a sugary breakfast meal inhibits the ability of the body to burn fat for the entire day. In contrast, a breakfast meal with more fat enabled the animals to burn fat as well as other fuels throughout the day. The ability to burn fat is thought to minimize risk for obesity, as well as related diseases such as type 2 diabetes and heart disease. The purpose of this study is to determine if, in older adult humans, consumption of a lower-carbohydrate breakfast meal (relative to a higher-carbohydrate meal) is associated with a healthier metabolism.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Dec 2011

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

December 14, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

May 15, 2017

Last Update Submit

May 22, 2017

Conditions

DiabetesHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • Respiratory quotient (RQ, a measure of substrate oxidation)

    24 hour respiratory quotient will be measured using whole-room indirect calorimetry

    4 weeks

Study Arms (2)

High fat breakfast

EXPERIMENTAL

45% fat 35% Carbohydrate 20% protein

Other: High fat breakfast

Higher carbohydrate breakfast

EXPERIMENTAL

60% carbohydrate 20% fat 20% protein

Other: Higher carbohydrate breakfast

Interventions

High fat breakfastOTHER

High fat breakfast

High fat breakfast
Higher carbohydrate breakfastOTHER

Higher carbohydrate breakfast

Higher carbohydrate breakfast

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55-75
  • Body mass index 24-29 kg/m2

You may not qualify if:

  • Current practice of greater than 2h/wk of moderate intentional exercise
  • Uncontrolled diabetes
  • Unwillingness to eat study diets
  • Use of any medication known to affect metabolism
  • History of eating disorder
  • Difficulty chewing and swallowing solid food
  • Digestive diseases
  • Cognitive impairment
  • Depression
  • Recent weight change (+/- 10 lbs. in the last 12 mo.)
  • Poorly controlled blood pressure (SBP \> 159 or DBP \>95 mm Hg)
  • History of non-skin cancer in the last 5 y
  • Cardiovascular disease event in the past 6 mo.
  • Severe pulmonary disease
  • Renal failure
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bush NC, Resuehr HES, Goree LL, Locher JL, Bray MS, Soleymani T, Gower BA. A High-Fat Compared with a High-Carbohydrate Breakfast Enhances 24-Hour Fat Oxidation in Older Adults. J Nutr. 2018 Feb 1;148(2):220-226. doi: 10.1093/jn/nxx040.

    PMID: 29490097DERIVED

MeSH Terms

Conditions

Diabetes MellitusHeart Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCardiovascular Diseases

Study Officials

  • Barbara Gower, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Patients were randomized to either a egg breakfast or a carbohydrate breakfast
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 23, 2017

Study Start

December 14, 2011

Primary Completion

October 30, 2013

Study Completion

October 30, 2013

Last Updated

May 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share