N/A
N=36
Application of New Technologies and Tools to Nutrition Research
Obesity · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01684917 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Insulin Sensitivity — 4.2; 7.6; 5.4; 10.4 mg/kg/min — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Metabolomic and Energy Intake Restriction (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Sensitivity |
4.2; 7.6; 5.4; 10.4 | <0.05 sig |
| PRIMARY Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol |
5.6; 5.6; 5.1; 4.9; 5.8; 4.9 | <0.05 sig |
| SECONDARY Body Composition |
28.9; 30.8; 23.5; 29.1; 28.6; 29.2 | <0.05 sig |
| SECONDARY Changes in Adipocyte Morphology |
-10.9; -8.9; -8.5; 3.7 | <0.05 sig |
| SECONDARY Genome Integrity (DNA Methylation and Telomere Length) |
— | — |
| SECONDARY Body Weight |
92.9; 91.9; 78.5; 84.7; 91.6; 87.3 | <0.05 sig |
Summary
The overall objective of the research is to develop new methods for studying the link between diet, health and disease.
Eligibility Criteria
Inclusion Criteria
- Healthy overweight volunteers (body mass index (BMI) of 25-30 kg/m2)
- Age between 50-65 years
Exclusion Criteria
- Weight change of ≥ 3kg in the preceding 3 months
- Current smokers
- Substance abuse
- Excess alcohol intake
- Pregnancy
- Diabetes
- Cardiovascular disease
- Cancer
- Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- Kidney disease
- Liver disease
- Pancreatitis
- Have any metallic or magnetic implants such as pacemakers
- Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
Data sourced from ClinicalTrials.gov (NCT01684917). 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.