The Timing of Main Meal Consumption Effect on Gut Microbiota and Host

NCT03949543 | Completed

• 1 other identifier: 200170046
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The interplay between diet and the gut microbiota has been implicated in the onset of cardiovascular disease. The gut microbiota displays diurnal rhythms, which may be influenced by meal timing. This study aimed to investigate the effect of main meal consumption timing on the microbiota and the cardiometabolic factors of the host using a cross-over RCT in healthy adults The main outcome measurements will be: a) changes in gut microbiota composition based on 16S rRNA gene amplicon sequencing and shotgun metagenomics, b) changes in bacterial functional capacity) and urinary/faecal metabolomics, c) changes in targeted bacterial metabolites, d)Inflammatory markers The aim of this study is to explore the effect of the timing of main meal consumption on gut microbiota and immune response in healthy adults.

Conditions

Feeding Behavior; Gastrointestinal Microbiome; Diet; Meal Time

Outcome Measures

Primary Outcomes (2)

• Gut microbiome alpha diversity

  Shannon diversity index

  7 days post-intervention

• Faecal short chain fatty acids

  Short chain fatty acids (umol/g)

  7 days post-intervention

Secondary Outcomes (7)

• HDL

  7 days post-intervention

• LDL

  7 days post-intervention

• Triglycerides

  7 days post-intervention

• Glucose

  7 days post-intervention

• Insulin

  7 days post-intervention

Study Arms (2)

Healthy Adult Participants A

EXPERIMENTAL

Participants who will get two interventional diets, for 7 days each, but allocated to start with large lunch intervention

Other: Large Lunch Intervention; Other: Large Dinner Intervention

Healthy Adult Participants B

EXPERIMENTAL

Participants who will get two interventional diets, for 7 days each, but allocated to start with large dinner intervention

Other: Large Lunch Intervention; Other: Large Dinner Intervention

Interventions

Large Lunch Intervention OTHER

Participants were asked to consume 60% of their daily energy requirements as lunch, between 12:30 and 13:30. Breakfast accounted for 15% of their total daily energy, a morning and evening snack for 5%. 15% was given for light meal either as dinner.

Healthy Adult Participants A; Healthy Adult Participants B

Large Dinner Intervention OTHER

Participants were asked to consume 60% of their daily energy requirements as dinner, between 19:30 and 20:30, each day during their two dietary interventions. Breakfast accounted for 15% of their total daily energy, a morning and evening snack for 5%. 15% was given for light meal either as lunch.

Healthy Adult Participants A; Healthy Adult Participants B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Healthy adult people

You may not qualify if:

• History of gut surgery
• Use of antibiotics or steroids the last 3 months
• Positive or negative energy balance (recent weight gain or loss, ±2 Kg the past month)

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

School of Medicine, University of Glasgow / New Lister Building, Glasgow Royal Infirmary

Glasgow, G312ER, United Kingdom

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Konstantinos Gerasimidis, BSc MSc PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Clinical Nutrition

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 14, 2019
• Study Start: October 10, 2017
• Primary Completion: May 28, 2018
• Study Completion: May 28, 2018
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)