CompletedNot Applicable

A Pilot Study of a Low Glycemic Load Diet in Adults With Cystic Fibrosis

United States11 participantsStarted 2021-10-25

Plain-language summary

This pilot study will evaluate the safety and tolerability of a low glycemic load dietary intervention in adult patients with cystic fibrosis (CF) in a rigorous feeding study. Specific emphasis will be placed on changes in weight, body composition, and glycemic measures obtained via continuous glucose monitor (CGM) usage.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Diagnosis of CF
✓. Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement
✓. Oral glucose tolerance test within the past three years showing impaired glucose tolerance (2-hour glucose ≥140 mg/dL) or indeterminate glycemia (1-hour glucose ≥200), HbA1c 5.7-6.4% in the past one year, and/or or documented random glucose ≥200 in the past one year
✓. BMI 21-25 kg/m2
✓. 18 years and above

Exclusion criteria

✕. Current use of insulin
✕. Most recent HbA1c ≥6.5%
✕. History of solid organ transplant or currently listed for solid organ transplant
✕. FEV1 \<50% predicted on most recent pulmonary function testing
✕. Currently receiving enteral nutrition support
✕. Current or anticipated pregnancy in the next 1 year
✕. Hospitalization for CF exacerbation within 1 month of enrollment
✕. Started or stopped treatment with Trikafta or other CFTR modulator within 3 months of enrollment

What they're measuring

Change in weight from baseline and 10 weeks

Timeframe: Baseline and 10 weeks

Change in percent time <54 mg/dL

Timeframe: Baseline and 10 weeks

Patient reported tolerability of dietary intervention, Likert scale

Timeframe: Single measurement at 10 weeks after diet completion

Trial details

NCT IDNCT04519853

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-01

View on ClinicalTrials.gov More Cystic Fibrosis trials