Low Glycemic Load Diet for Cystic Fibrosis

Boston Children's Hospital, Boston, MA
Cystic Fibrosis+2 More ConditionsLow Glycemic Load Diet - Behavioral
18 - 70
All Sexes

Study Summary

This trialwill test if a low glycemic diet is safe and helpful for adults with CF, looking at changes in weight, body composition and glucose levels.

Eligible Conditions
  • Diabetes-Related Cystic Fibrosis
  • Cystic Fibrosis with Intestinal Manifestations
  • Cystic Fibrosis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

3 Primary · 19 Secondary · Reporting Duration: Baseline to 10 weeks

Baseline and 10 weeks
Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) score
Change in Modified Activity Questionnaire (MAQ) score
Change in Patient Assessment of Constipation (PAC) questionnaire score
Change in Patient Assessment of Gastrointestinal Symptom (PAGI-SYM) questionnaire score
Change in c-reactive protein (CRP)
Change in erythrocyte sedimentation rate (ESR)
Change in intestinal fatty acid binding protein (I-FABP)
Change in lean and fat mass
Change in percent time <54 mg/dL
Change in weight from baseline and 10 weeks
Number of episodes of symptomatic hypoglycemia
Baseline to 10 weeks
Change in CGM average glucose
Change in CGM coefficient of variation (CV)
Change in CGM glucose management indicator (GMI)
Change in CGM standard deviation (SD)
Change in percent time 70-180 mg/dL on CGM
Change in percent time >140 mg/dL
Change in percent time greater than 180 mg/dL on CGM
Change in percent time greater than >250 mg/dL on CGM
Change in percent time less than 50 mg/dL on CGM
Change in percent time less than 70 mg/dL on CGM
Week 10
Patient reported tolerability of dietary intervention, Likert scale

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Low Glycemic Load Diet
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Low Glycemic Load Diet · No Placebo Group · N/A

Low Glycemic Load Diet
Experimental Group · 1 Intervention: Low Glycemic Load Diet · Intervention Types: Behavioral
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Glycemic Load Diet

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 10 weeks

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
726 Previous Clinical Trials
5,432,042 Total Patients Enrolled
16 Trials studying Cystic Fibrosis
1,665 Patients Enrolled for Cystic Fibrosis
Melissa S Putman, MD,MSPrincipal InvestigatorBoston Children's Hospital; Massachusetts General Hospital

Eligibility Criteria

Age 18 - 70 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your body mass index (BMI) is between 21 and 25 kilograms per square meter.