Metabolic Disease Clinical Trial
Official title:
Gut, Grain and Greens (3G): The Effect of Wholegrain on Gut Microbiome and Metabolic Health
Objective: To identify how specific changes of the whole grain content in the diet affect
the host-gut microbiome interactions with implications for metabolic health .
Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting
of two 8-week intervention periods, separated by a 6-week wash-out period. A total of 60
participants will be included.
Intervention: low vs. high whole grain intake.
The study is designed as a randomized, controlled, single-blinded, cross-over intervention
trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period.
A total number of 60 participants will be included. Participants consume, in randomized
order, a diet rich in whole grain in the active treatment period and a refined grain diet
during the control period.
Measurements: Insulin sensitivity will be assessed by means of a meal challenge test and by
the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) which is the primary
outcome of this study. Secondary outcomes include metabolic and inflammatory markers,
appetite hormones, transit time, and GM composition. Furthermore, selected control measures
are included; 4-day food records and a study intervention diary.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06188728 -
Husk Fiber Intervention on Metabolic Health of Centrally Obese School Teachers
|
N/A | |
| Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
| Recruiting |
NCT05081037 -
Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)
|
N/A | |
| Recruiting |
NCT05318196 -
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
|
||
| Not yet recruiting |
NCT05461144 -
AI Models for Non-invasive Glycaemic Event Detection Using ECG in Type 1 Diabetics
|
||
| Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
| Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A | |
| Active, not recruiting |
NCT05505994 -
The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin
|
Phase 3 | |
| Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
| Completed |
NCT03675360 -
Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
|
N/A | |
| Recruiting |
NCT05711758 -
Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
|
||
| Recruiting |
NCT05112029 -
Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females
|
||
| Recruiting |
NCT03682640 -
Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes
|
Phase 2 | |
| Completed |
NCT04854603 -
Dairy Products With Reduced Sugar and Blood Glucose
|
N/A | |
| Recruiting |
NCT06024291 -
Reducing Circulating Sphingolipid Levels to Optimise Cardiometabolic Health - The SphingoFIT Trial
|
N/A | |
| Recruiting |
NCT04904601 -
Freeze-dried Kale to Reduce Metabolic Risk in Saudi Subjects
|
N/A | |
| Recruiting |
NCT04109586 -
Diet and Fat Mass After Traumatic Spinal Cord Injury
|
N/A | |
| Recruiting |
NCT06009653 -
Effect of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
|
Phase 4 | |
| Completed |
NCT03067012 -
Nutritional Safety and Metabolic Benefits of Oncometabolic Surgery for Obese Gastric Cancer Patients
|
N/A | |
| Recruiting |
NCT03309423 -
Is Venous to Arterial Conversion (v-TAC) of Blood Gas Reliable in Critical Ill Patients in the ICU?
|
N/A |