N/A
Completed N=60
Dietary Carbohydrate Manipulation and Energy Balance: RCT
Physical Activity · Diet Modification
Source: ClinicalTrials.gov NCT03574987 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Physical Activity Energy Expenditure (kJ/Day or kcal/Day) — 1229; 1096; 1275; 1142 kcal/d
Summary
This study will investigate how dietary sugar and carbohydrates influence metabolism and health across a 12-week period, with a focus on physical activity. One third of participants will eat a diet with typical amounts of sugar and carbohydrate, one third of participants will eat a diet with sugar intake restricted, and the final third of participants will eat a diet where both sugar and total carbohydrates are restricted and replaced with fat.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Activity Energy Expenditure (kJ/Day or kcal/Day) |
1229; 1096; 1275; 1142; 1077; 1136 | — |
| SECONDARY Time Spent in Different Physical Activity Intensities (MET Categories) (Minutes) |
— | — |
| SECONDARY Energy Expended in Different Physical Activity Intensities (MET Categories) (kJ or kcal) |
— | — |
| SECONDARY Energy Intake and Dietary Macronutrient Composition |
— | — |
| SECONDARY Body Mass |
— | — |
| SECONDARY Bone Mineral Density |
— | — |
| SECONDARY Bone Mineral Content |
— | — |
| SECONDARY Fat Mass |
— | — |
| SECONDARY Fat-free Mass |
— | — |
| SECONDARY Android Fat Mass |
— | — |
| SECONDARY Gynoid Fat Mass |
— | — |
| SECONDARY Resting Metabolic Rate |
— | — |
| SECONDARY Substrate Oxidation |
— | — |
| SECONDARY Waist and Hip Circumference |
— | — |
| SECONDARY Step Count |
— | — |
| SECONDARY Fasting Metabolite/Hormone Profile |
— | — |
| SECONDARY Postprandial Metabolite/Hormone Profile |
— | — |
| SECONDARY Blood Pressure |
— | — |
| SECONDARY Food Preference Ratings |
— | — |
| SECONDARY Subjective Appetite and Mood Ratings |
— | — |
| SECONDARY Interstitial Glucose Concentrations |
— | — |
| SECONDARY Adipose Tissue Gene Expression |
— | — |
| SECONDARY Adipose Tissue Protein Expression |
— | — |
| SECONDARY Muscle Tissue Gene Expression |
— | — |
| SECONDARY Muscle Tissue Protein Expression |
— | — |
| SECONDARY Muscle Glycogen Concentrations |
— | — |
| SECONDARY Gut Microbiome Characterisation |
— | — |
| SECONDARY Urinary Acetoacetate Concentrations |
— | — |
| SECONDARY Urine Urea Nitrogen Excretion |
— | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index 18.5-29.9 kg∙m-2
- Age 18-65 years
- Able and willing to provide informed consent and safely comply with study procedures
- Females to maintain record of regular menstrual cycle phase/contraceptive use
- No anticipated changes in physical activity during the first 4 weeks of the study (e.g. holidays or training programmes)
Exclusion Criteria
- Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
- Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
- Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- Any reported recent (<6 months) change in body mass (± 3%)
- Use of antibiotic medication in the last 3 months
- Use of prebiotic or probiotic products in the last month
Data sourced from ClinicalTrials.gov (NCT03574987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.