Low-Sugar High-Fat Diet for Cystic Fibrosis
(FEED-CF Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Emory University
Must not be taking: Steroids
Disqualifiers: CFRD, Pregnancy, Lactation, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial will test if a low-sugar diet can reduce diabetes risk and organ fat in adults with cystic fibrosis. Participants will follow either a low-sugar, high-fat diet or their usual CF diet for a few months. The goal is to see if cutting down on sugar improves health outcomes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that your medical regimen, including medications, has not changed for at least 21 days before the study. This suggests that you should not make changes to your medications right before or during the trial.
What data supports the effectiveness of the Low-Sugar High-Fat Diet treatment for Cystic Fibrosis?
Is a low-sugar high-fat diet generally safe for humans?
Research suggests that high-fat diets are associated with obesity, but there is no clear evidence that normal levels of added sugars in the diet uniquely increase the risk of obesity, diabetes, or heart disease. However, the combination of high sugar and high fat may promote obesity and metabolic issues, so caution is advised.46789
How does the low-sugar high-fat diet treatment for cystic fibrosis differ from other treatments?
This treatment is unique because it focuses on reducing added sugars while maintaining a high-fat intake, which is different from typical dietary advice that often restricts both sugar and fat. This approach may help manage energy intake and nutritional needs specific to cystic fibrosis, where maintaining a high-calorie diet is crucial.410111213
Eligibility Criteria
Adults over 18 with confirmed cystic fibrosis, who consume more than 16 teaspoons of added sugar daily and have exocrine pancreatic insufficiency can join. Those with CFRD, recent CFTR modulator use, organ transplant waiting list status, life expectancy under a year, uncontrolled conditions or dietary restrictions that conflict with the study's menu are excluded.Inclusion Criteria
I am 18 years old or older.
I have been diagnosed with cystic fibrosis based on sweat test or genetic testing.
My pancreas does not produce enough digestive enzymes.
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Exclusion Criteria
Current pregnancy or lactation or plans to become pregnant during study period
Any food allergies or intolerances that cannot be accommodated
Actively trying to gain or lose weight (May re-screen at a later date)
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 visit
1 visit (in-person)
Baseline
Baseline visit for an insulin secretion test and MRI testing to measure visceral fat
1 visit
1 visit (in-person)
Treatment
Participants receive either a low-added sugar, high-fat diet or a typical CF diet for 8 weeks
8 weeks
Food delivered every 3-4 days
Midpoint Check-in
4-week visit for an oral glucose tolerance test and in-person check-in
1 visit
1 visit (in-person)
Follow-up
8-week visit for another GPA and MRI to assess changes in risk markers for diabetes and visceral fat
1 visit
1 visit (in-person)
Treatment Details
Interventions
- High-added sugar, high-fat CF diet (Behavioural Intervention)
- Low-added sugar, high-fat diet (Behavioural Intervention)
Trial OverviewThe FEED-CF trial is testing how diet affects diabetes risk in cystic fibrosis patients by comparing two diets: one low in added sugars but high in fats versus the standard high-sugar, high-fat CF diet. Participants will be randomly assigned to one of these diets for 8 weeks.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Low-added sugar, high-fat diet ArmExperimental Treatment1 Intervention
Patients will receive a low-added sugar, high-fat diet for 8 weeks. Study menus will be designed by registered dietitians using the Nutrient Database System for Research (NDSR) software program with a 2-wk rotation.Total kcal provided will be individually tailored to maintain body weight and adjusted throughout as needed. All foods (including snacks and drinks) for 8 wks will be delivered to participants' homes. Menus will be designed so that food will be delivered to subjects' homes every 3-4 days. It will be expected that participants consume only the foods provided by the study.
Group II: Typical CF diet ArmActive Control1 Intervention
Patients will receive a high-added sugar, high-fat CF diet for 8 weeks. Study menus will be designed by registered dietitians using the Nutrient Database System for Research (NDSR) software program with a 2-wk rotation. Total kcal provided will be individually tailored to maintain body weight and adjusted throughout as needed. All foods (including snacks and drinks) for 8 wks will be delivered to participants' homes. Menus will be designed so that food will be delivered to subjects' homes every 3-4 days. It will be expected that participants consume only the foods provided by the study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Emory University HospitalAtlanta, GA
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Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
How important is the relative balance of fat and carbohydrate as sources of energy in relation to health? [2022]Both the intake of fat, especially saturated trans fatty acids, and refined carbohydrates, particularly sugar, have been linked to increased risk of obesity, diabetes and CVD. Dietary guidelines are generally similar throughout the world, restrict both intake of SFA and added sugar to no more than 10 and 35 % energy for total fat and recommend 50 % energy from carbohydrates being derived from unrefined cereals, tubers, fruit and vegetables. Current evidence favours partial replacement of SFA with PUFA with regard to risk of CVD. The translation of these macronutrient targets into food-based dietary guidelines is more complex because some high-fat foods play an important part in meeting nutrient requirements as well as influencing the risk of chronic disease. Some of the recent controversies surrounding the significance of sugar and the type of fat in the diet are discussed. Finally, data from a recently published randomised controlled trial are presented to show the impact of following current dietary guidelines on cardiovascular risk and nutrient intake compared with a traditional UK diet.
Decreases in High-Fat and/or High-Added-Sugar Food Group Intake Occur when a Hypocaloric, Low-Fat Diet Is Prescribed Within a Lifestyle Intervention: A Secondary Cohort Analysis. [2021]When a hypocaloric, low-fat diet is prescribed, intake of currently consumed foods can decrease, foods naturally low in fat and/or added sugar may increase, or fat- or sugar-modified foods may increase.
Clinical approaches to healthier diet modifications. [2017]There is a strong relation between diet and risk factors for cardiovascular diseases. Generally a high fat consumption will increase the serum cholesterol level. Different fatty acids have different effects on total cholesterol, LDL and HDL lipoproteins and therefore on the risk for cardiovascular diseases. This knowledge was translated into guidelines for a healthy diet and in advices to use less fat. In reality it was not easy for physicians to reach a substantial reduction in total cholesterol by limiting the fat consumption. A recent investigation in Belgium showed that the median reduction obtained by dietary changes through general practitioners was only 3.5%. In medical education not much attention is paid to the communication of the "fat message". In addition, individual patients have frequently multiple risk factors e.g. abdominal obesity, insulin resistance, diabetes, hypertension and a sedentary lifestyle. Therefore in the clinical setting an integrated approach is needed, in which dietary advice is supported by behavioural therapy and suggestions to increase physical activity. Currently there is a debate on the preference of a low fat or a modified fat diet. A low fat diet is rich in carbohydrates and a modified fat diet is rich in mono-unsaturated fatty acids. Recent investigations in diabetic patients are in favour of a modified fat diet. This has the advantage that in practice the possibilities for realizing a low saturated fat diet are increased.
Sugar and body weight regulation. [2018]The need to understand reasons for the high prevalence of obesity in developed countries has led to examination of dietary habits that may contribute to obesity. We consider whether consumption of high amounts of sugars presents a public health problem by contributing to the development of obesity. Metabolic studies show that diets high in fat are more likely to result in body fat accumulation than are diets high in carbohydrate. There is no indication that simple sugars differ from complex sugars in this regard. Epidemiologic data show a clear inverse relation between intake of sugar and fat. Further, although high intake of dietary fat is positively associated with indexes of obesity, high intake of sugar is negatively associated with indexes of obesity. There is ample reason to associate high-fat diets with obesity but, at present, no reason to associate high-sugar diets with obesity.
Associations between added sugar (solid vs. liquid) intakes, diet quality, and adiposity indicators in Canadian children. [2016]Little is known about the influence of different forms of added sugar intake on diet quality or their association with obesity among youth. Dietary intake was assessed by three 24-h recalls in 613 Canadian children (aged 8-10 years). Added sugars (mean of 3-day intakes) were categorized according to source (solid or liquid). Dietary intake and the Canadian Healthy Eating Index (« HEI-C ») were compared across tertiles of solid and liquid added sugars separately as were adiposity indicators (body mass index (BMI), fat mass (dual-energy X-ray absorptiometry), and waist circumference). Cross-sectional associations were examined in linear regression models adjusting for age, sex, energy intake, and physical activity (7-day accelerometer). Added sugar contributed 12% of total energy intake (204 kcal) on average, of which 78% was from solid sources. Higher consumption of added sugars from either solid or liquid source was associated with higher total energy, lower intake of micronutrients, vegetables and fruit, and lower HEI-C score. Additionally liquid sources were associated with lower intake of dairy products. A 10-g higher consumption of added sugars from liquid sources was associated with 0.4 serving/day lower of vegetables and fruit, 0.4-kg/m(2) higher BMI, a 0.5-kg higher fat mass, and a 0.9-cm higher waist circumference whereas the associations of added sugars from solid sources and adiposity indicators tended to be negative. In conclusion, higher consumption of added sugar from either solid or liquid sources was associated with lower overall diet quality. Adiposity indicators were only positively associated with added sugars from liquid sources.
Ketohexokinase-C regulates global protein acetylation to decrease carnitine palmitoyltransferase 1a-mediated fatty acid oxidation. [2023]The consumption of sugar and a high-fat diet (HFD) promotes the development of obesity and metabolic dysfunction. Despite their well-known synergy, the mechanisms by which sugar worsens the outcomes associated with a HFD are largely elusive.
Added sugars and risk factors for obesity, diabetes and heart disease. [2022]The effects of added sugars on various chronic conditions are highly controversial. Some investigators have argued that added sugars increase the risk of obesity, diabetes and cardiovascular disease. However, few randomized controlled trials are available to support these assertions. The literature is further complicated by animal studies, as well as studies which compare pure fructose to pure glucose (neither of which is consumed to any appreciable degree in the human diet) and studies where large doses of added sugars beyond normal levels of human consumption have been administered. Various scientific and public health organizations have offered disparate recommendations for upper limits of added sugar. In this article, we will review recent randomized controlled trials and prospective cohort studies. We conclude that the normal added sugars in the human diet (for example, sucrose, high-fructose corn syrup and isoglucose) when consumed within the normal range of normal human consumption or substituted isoenergetically for other carbohydrates, do not appear to cause a unique risk of obesity, diabetes or cardiovascular disease.
Weight classification does not influence the short-term endocrine or metabolic effects of high-fructose corn syrup-sweetened beverages. [2014]Obesity and high-fructose corn syrup (HFCS)-sweetened beverages are associated with an increased risk of chronic disease, but it is not clear whether obese (Ob) individuals are more susceptible to the detrimental effects of HFCS-sweetened beverages. The purpose of this study was to examine the endocrine and metabolic effects of consuming HFCS-sweetened beverages, and whether weight classification (normal weight (NW) vs. Ob) influences these effects. Ten NW and 10 Ob men and women who habitually consumed ≤355 mL per day of sugar-sweetened beverages were included in this study. Initially, the participants underwent a 4-h mixed-meal test after a 12-h overnight fast to assess insulin sensitivity, pancreatic and gut endocrine responses, insulin secretion and clearance, and glucose, triacylglycerol, and cholesterol responses. Next, the participants consumed their normal diet ad libitum, with 1065 mL per day (117 g·day(-1)) of HFCS-sweetened beverages added for 2 weeks. After the intervention, the participants repeated the mixed-meal test. HFCS-sweetened beverages did not significantly alter body weight, insulin sensitivity, insulin secretion or clearance, or endocrine, glucose, lipid, or cholesterol responses in either NW or Ob individuals. Regardless of previous diet, Ob individuals, compared with NW individuals, had ∼28% lower physical activity levels, 6%-9% lower insulin sensitivity, 12%-16% lower fasting high-density-lipoprotein cholesterol concentrations, 84%-144% greater postprandial triacylglycerol concentrations, and 46%-79% greater postprandial insulin concentrations. Greater insulin responses were associated with reduced insulin clearance, and there were no differences in insulin secretion. These findings suggest that weight classification does not influence the short-term endocrine and metabolic effects of HFCS-sweetened beverages.
Commercial complementary food consumption is prospectively associated with added sugar intake in childhood. [2018]Given that commercial complementary food (CF) can contain high levels of added sugar, a high consumption may predispose to a preference for sweet taste later in life. This study examined cross-sectional associations between commercial CF consumption and added sugar intake in infancy as well as its prospective relation to added sugar intake in pre-school and primary-school age children. In all, 288 children of the Dortmund Nutritional and Anthropometric Longitudinally Designed Study with 3-d weighed dietary records at 0·5 and 0·75 (infancy), 3 and 4 (pre-school age) and 6 and 7 years of age (primary-school age) were included in this analysis. Individual commercial CF consumption as percentage of total commercial CF (%cCF) was averaged at 0·5 and 0·75 years. Individual total added sugar intake (g/d, energy percentage/d) was averaged for all three age groups. Multivariable logistic and linear regression models were used to analyse associations between %cCF and added sugar intake. In infancy, a higher %cCF was associated with odds for high added sugar intake from CF and for high total added sugar intake (>75th percentile, P
Is a low fat diet the optimal way to cut energy intake over the long-term in overweight people? [2006]Successful weight loss depends on maintaining a sustained negative energy balance. This can be achieved on diets with a normal (40% energy) fat content as well as on low fat diets. Using a 'modified fat' (MF) diet enriched with monounsaturated fat (MUFA), body weight may be lost either by calorie counting, or by allowing ad libitum food intake with careful food selection. In the latter approach high energy, high MUFA foods (predominantly olive oil, but also may include nuts and avocado) should contribute no more than 20% total energy to the diet, and other foods should be selected to minimise meal energy density. This can be achieved simply by the consumption of a wide variety of vegetables and whole grain cereal foods. It is also important to restrict foods high in saturated fat and to encourage regular exercise. Such a 'modified fat' low energy diet designed for weight loss should also contribute numerous health benefits in relation to improved metabolic control in Type 2 diabetes and reduced cardiovascular disease risk (as the diet is not only rich in MUFA but also in a range of dietary antioxidants and other bio-active phytochemicals).
Covert manipulation of the dietary fat to carbohydrate ratio of isoenergetically dense diets: effect on food intake in feeding men ad libitum. [2014]High-fat, high energy-density (HF, HED) diets promote an increase in energy intakes relative to low-fat lower-energy density diets (LF, LED). This study examined whether HF diets promote higher levels of energy intake when isoenergetically dense (IE) relative to LF (high carbohydrate) diets, as predicted by glucostatic and glycogenostatic models for energy intake regulation.
Are high-fat, high-sugar foods and diets conducive to obesity? [2019]Restriction of both dietary fat and extrinsic sugars is standard advice for weight reduction. It has been suggested that foods, and diets, that combine high levels of sugars and fat particularly contribute to overconsumption. Weighed dietary data on 1087 men and 1110 women aged 16-64 who took part in the Dietary and Nutritional Survey of British Adults were examined for evidence of this hypothesis. Consumption of the main sugary fatty foods (cakes, biscuits, confectionery and puddings) averaged 12% of energy for men, 14.9% for women. Intake of these foods (as a proportion of total energy) was inversely related to BMI (adjusted for age and smoking). After exclusion of the substantial number who were dieting or unwell or who may have under-reported their intakes, the association remained significant only in men. Consumption of sugary fatty foods showed a positive association with intakes of fibre, a negative association with vegetables and no relationship with percentage of energy from fat. For the investigation of diet composition, men and women were divided into four groups, high or low in extrinsic sugars energy (cut point 15%) and fat energy (cut point 40%). For men consuming high fat diets (> 40% energy) mean BMI was higher in the low sugar group. After exclusion of dieters and unwell, men with low sugar intakes still had a higher mean BMI than men with high sugar intakes. BMI and extrinsic sugars energy were still negatively but weakly correlated (r = -0.10; P
Individual Diet Modeling Shows How to Balance the Diet of French Adults with or without Excessive Free Sugar Intakes. [2023]Dietary changes needed to achieve nutritional adequacy for 33 nutrients were determined for 1719 adults from a representative French national dietary survey. For each individual, an iso-energy nutritionally adequate diet was generated using diet modeling, staying as close as possible to the observed diet. The French food composition table was completed with free sugar (FS) content. Results were analyzed separately for individuals with FS intakes in their observed diets ≤10% or >10% of their energy intake (named below FS-ACCEPTABLE and FS-EXCESS, respectively). The FS-EXCESS group represented 41% of the total population (average energy intake of 14.2% from FS). Compared with FS-ACCEPTABLE individuals, FS-EXCESS individuals had diets of lower nutritional quality and consumed more energy (2192 vs. 2123 kcal/day), particularly during snacking occasions (258 vs. 131 kcal/day) (all p-values < 0.01). In order to meet nutritional targets, for both FS-ACCEPTABLE and FS-EXCESS individuals, the main dietary changes in optimized diets were significant increases in fresh fruits, starchy foods, water, hot beverages and plain yogurts; and significant decreases in mixed dishes/sandwiches, meat/eggs/fish and cheese. For FS-EXCESS individuals only, the optimization process significantly increased vegetables and significantly decreased sugar-sweetened beverages, sweet products and fruit juices. The diets of French adults with excessive intakes of FS are of lower nutritional quality, but can be optimized via specific dietary changes.