Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Jan 15, 2020

Keywords

ClinConnect Summary

**Trial Summary: Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial**

This clinical trial is looking at how a low-carbohydrate diet can help manage blood sugar levels and body weight in people who are overweight or obese, particularly those with pre-diabetes or diabetes. The study will take place over six months and will include both healthy individuals and those who are struggling with glucose intolerance. Researchers want to understand how changing what we eat can affect our bodies and how our brains respond to these changes.

To participate, you might qualify if you are between 65 and 88 years old and fit into one of two groups: healthy individuals with a normal weight or those who are obese with pre-diabetes or diabetes. You need to have stable eating habits and a stable body weight for at least three months. Participants will be asked to follow a specific low-carb diet, and they can expect regular check-ins to monitor their health and progress. This study is currently recruiting participants, and taking part could help contribute to important findings about diet and health. If you’re interested, it’s essential to check if you meet the eligibility criteria and discuss with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Group A: HEALTHY LEAN CONTROLS
• • Healthy normal weight subjects with a body-mass index of 19.0-24.9kg/m2, HbA1C \<5.7% and fasting glucose \<5.6 mmol/l
• • Normal eating habits
• • Stable body weight for at least three months
• • Informed Consent as documented by signature
• • Group B: PRE-DIABETIC or DIABETIC OBESE
• • Pre-diabetic/Diabetic obese with a HbA1C \>5.7% and/or fasting glucose \>5.6 mmol/l) and body-mass index \> 30kg/m2, otherwise healthy
• • Normal eating habits
• • Stable body weight for at least three months
• • Informed Consent as documented by signature
• Exclusion Criteria:
• • Group A: HEALTHY LEAN CONTROLS
• • Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates)
• • Pre-existing diet (vegetarian, vegan, gluten-free etc.)
• • Psychiatric illness
• • Alcohol abuse, (smoking allowed)
• • Regular intake of medications, (oral contraceptives allowed)
• • Intake of antibiotics within the last 3 months before inclusion
• • Regular intake of pro- or prebiotics
• • Chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery)
• • Clinically relevant acute or chronic inflammatory disease
• • Pregnancy
• • Participation in another study with investigational drug within the 30 days preceding and during the present study.
• • Group B: PRE-DIABETIC or DIABETIC OBESE
• • Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates)
• • Pre-existing diet (vegetarian, vegan, gluten-free etc.)
• • Psychiatric illness
• • Alcohol abuse, (smoking allowed)
• • Regular intake of medications (except: oral contraceptives, metformin, SGLT-2, statins, and antihypertensive, which are allowed)
• • Intake of antibiotics within the last 3 months before inclusion
• • Regular intake of pro- or prebiotics
• • Chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery)
• • Clinically relevant acute or chronic inflammatory disease
• • Pregnancy
• • Participation in another study with investigational drug within the 30 days preceding and during the present study.