The Effect of Nutrient Intake on the Microbiome, Weight, and Glucoregulation (NI-MWG)

Obesity Clinical Trial

— NI-MWG  

Official title:

Is Weight Change and Glucoregulation Related to Dietary Intake, the Gut Microbiome or the Interaction Between The Two Variables?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076424
• Other study ID #: NDSU-PS
• Status: Completed
• Start date: March 8, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2018
• Source: North Dakota State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate a persons dietary intake and its effect on the gut microbiome and the association of those two variables on weight and glucoregulation. Specifically, the investigators will compare the gut microbiota, fasting glucose and insulin, c-peptide and hemoglobin A1-c in three groups of subjects: obese patients (BMI ≥ 30 kg/m2) with type 2 diabetes mellitus (T2DM), obese patients without T2DM, and normal weight lean controls without T2DM. Each patient will also complete a detailed dietary recall (ASA-24) to investigate the association with diet, microbiome and weight/glucoregulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Female

2. Age 18-65 (inclusive, at time of informed consent)

3. BMI = 30 kg/m2 with T2DM

4. BMI = 30 kg/m2 without T2DM

5. Normal weight lean controls without T2DM

Exclusion Criteria:

1. Tobacco use in past three months - will add unnecessary confound to the data.

2. Taking a medication on a routine/recent basis which is known to significantly influence gastrointestinal transit time or affect the microbiome or other variables significantly (as determined by study pharmacist/MD)

3. Has taken an oral or injectable antibiotic in the past 3 months

4. Has taken a commercially prepared probiotic and/or prebiotic agent in the 3 months

5. History of significant intestinal disease or disorder (e.g., crohn's disease, ulcerative colitis)

6. History of gastrointestinal surgery that may impact measures of biological variables, as determined by the investigator

7. Medical condition expected to impact the biological variables of interest or interfere with providing a sample, as determined by the investigator.

8. Unable to speak/read English

9. Breastfeeding, pregnant, or planning to become pregnant within the duration of the study as assessed through self-report on medical history

10. Unwilling to use a medically acceptable form of contraception during study involvement. Medically acceptable forms of contraception include oral contraception, physical barrier methods and/or abstinence.

11. Any known infectious disease such as Viral Hepatitis or HIV (as determined by study pharmacist/MD)

Related Conditions & MeSH terms

• Obesity
• Type2 Diabetes

Intervention

Other:
• no intervention used
Patients will be giving a blood sample after 8 hours of fasting.

Locations

Country	Name	City	State
United States	Neuropsychiatric Research Institute (NRI)	Fargo	North Dakota

Sponsors (2)

Lead Sponsor	Collaborator
North Dakota State University	Neuropsychiatric Research Institute, Fargo, North Dakota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal Microbiome Composition	The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.	One sample collected upon study enrollment
Secondary	Fasting Glucose	Serum glucose (fasting) will be measured from collected blood sample and compared between the 3 subject groups.	One sample collected upon study enrollment
Secondary	Fasting Insulin	Plasma insulin (fasting) will be measured from collected blood sample and compared between the 3 subject groups.	One sample collected upon study enrollment
Secondary	C-peptide	c-peptide will be measured from collected blood sample and compared between the 3 subject groups.	One sample collected upon study enrollment
Secondary	Hemoglobin A1-c	hemoglobin A1-c will be measured from collected blood sample and compared between the 3 subject groups.	One sample collected upon study enrollment