Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels
Investigation Into the Postprandial Effects of Varying Calorie Content of Low-Carbohydrate Diets on Human Metabolic Health
1 other identifier
interventional
12
1 country
1
Brief Summary
This study investigates how different low-carbohydrate diets affect metabolism and hunger in overweight adults. We will measure metabolic rates and blood metabolites.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Nov 2019
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2022
CompletedFirst Submitted
Initial submission to the registry
April 17, 2024
CompletedFirst Posted
Study publicly available on registry
April 29, 2024
CompletedApril 29, 2024
April 1, 2024
5 months
April 17, 2024
April 23, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Biomarkers in blood Measured
Measured with ELISA assay and clinical analyser (INDIKO)
8 hours (fasting and post-meal)
Resting metabolic rate
Measured with indirect calorimetry (GEM)
8 hours (fasting and post-meal)
Secondary Outcomes (2)
Perceived Appetite Scores
8 hours (fasting and post-meal)
Food intake
baseline and after each diet arm for 1 day
Study Arms (3)
normal carbohydrate, energy-balanced diet, (nEB)
ACTIVE COMPARATORprovided participants' 100% daily energy needs, following the balanced Eatwell Guide recommendations.
low-carbohydrate, energy-balanced diet, (LCEB)
ACTIVE COMPARATORdiet contained just 50g of carbohydrates but still met 100% of the participants' estimated daily energy needs.
low-carbohydrate, energy-restricted diet, (LC25)
ACTIVE COMPARATORThe diet consisted of only 50g of carbohydrates and provided 25% of the estimated daily energy needs.
Interventions
nEB diet first, then LC25 and LCEB in random order with a 5 days washout between each diet
LC25 diet first, then nEB and LCEB in random order with a 5 days washout between each diet
LCEB diet first, then LC25 and nEB in random order with a 5 days washout between each diet
Eligibility Criteria
You may qualify if:
- stable weight within ±3 kg over the past three months
- no significant medical history.
You may not qualify if:
- pregnancy
- breastfeeding,
- using medications that could affect the study's outcomes
- high intake of caffeine and alcohol
- existing eating or psychiatric disorders
- adherence to strict dietary regimens like veganism
- high BMI resulting from significant muscle mass
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Surrey
Guildford, GU2 7XH, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Hayriye Biyikoglu
University of Surrey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2024
First Posted
April 29, 2024
Study Start
November 5, 2019
Primary Completion
April 1, 2020
Study Completion
November 20, 2022
Last Updated
April 29, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share